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Informex 2014 .......................... 3<br />
Partnerships Key to Success. .............. 3<br />
Conference schedule. .................... 4<br />
Show-at-a-Glance. ....................... 5<br />
SOCMA Management Services. ............ 6<br />
ChemStewards Program Serves Up Benefits. . 7<br />
Showcases: Part 2 ..................... 4–5<br />
Five Minutes With…<br />
Denis Geffroy, VP,<br />
Business Development, Almac. .......... 9<br />
Steward Tipson, VP, DrM. ................ 11<br />
Edward S. Price, President, PCI Synthesis. ... 17<br />
At Deadline: Late Breaking <strong>News</strong>. ......... 20<br />
Exhibitor <strong>News</strong>. ...................... 8–21<br />
Exhibition Map, List of Exhibitors ...... 12–13<br />
Exhibitor Photos. ....................... 22<br />
Advertiser Index. ....................... 21<br />
Knowing the<br />
Territory is Crucial<br />
for API Sourcing in<br />
Emerging Markets<br />
The hurdles of doing business in Asian countries<br />
require understanding the eclectic cultures<br />
and the serpentine regulations as well as<br />
assessing the capabilities of individual companies. “API<br />
Sourcing in Emerging Markets” presented perspectives<br />
on market growth in India and China, according to<br />
experts on Wednesday.<br />
India has had roots in the pharmaceutical market<br />
since the government started a company there in 1901.<br />
Thomas Speace, president of Neuland Laboratories<br />
described the benefits of doing business with India as<br />
relatively low cost manufacturing, abundant scientific<br />
talent, English being the lingua franca, strong informa-<br />
See API Sourcing page 23<br />
Early Start Adds<br />
to Green Chemistry<br />
Success, Efficiency<br />
Commitment to green chemistry means assessing<br />
the world’s “finite and diminishing resources,”<br />
according to David C. Constable, director of<br />
the <strong>American</strong> <strong>Chemical</strong> Society (ACS) Green Chemistry<br />
Institute, who presented a session on “Differentiating<br />
Yourself from the Competition in the Green Supply<br />
Chain” on Wednesday. Chemists should think about<br />
human and environmental impact, and companies have<br />
to design green chemistry into processes and find ways<br />
to assess its effectiveness, he said.<br />
“For instance, phosphorus is critical to the food<br />
supply,” he said. “There is only a 300-year supply, and<br />
we have no way to recycle it.” Green chemistry has<br />
focused on eliminating toxin usage and eliminating or<br />
reducing waste.<br />
See Green Chemistry page 23
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 3<br />
InformEx 2014—A High Value Event<br />
Pearl is the traditional gift<br />
Throughout the year,<br />
for 30th anniversaries—<br />
Informex’s key audiences will<br />
and like this precious<br />
be interviewed and surveyed<br />
gemstone—this milestone<br />
and their valuable insight will<br />
anniversary of InformexUSA will<br />
help shape the 30th Anniversary<br />
be a high value event in 2014.<br />
event as well as future editions.<br />
Taking place Jan. 21-24,<br />
The most popular ideas, top<br />
2014 in Miami, FL at the Miami<br />
interests and objectives will<br />
Beach Convention Center, this<br />
be incorporated into the 30th<br />
desirable venue is a convenient<br />
anniversary event. In addition,<br />
destination for Informex’s growing<br />
educational programming, new<br />
international audience.<br />
show features and networking<br />
This year, 34 percent of the<br />
and business-building opportunities<br />
will reflect the valuable<br />
Informex audience is international<br />
and that number is expected<br />
research and insight shared by<br />
to grow higher as Informex<br />
the Informex community.<br />
continues to be the global<br />
The 30th anniversary is<br />
marketplace for the chemical<br />
already shaping up to be a<br />
industry.<br />
memorable event, with more<br />
As Anaheim is in full swing,<br />
than 80 companies re-signing<br />
planning has already begun<br />
for 2014 booths so far, an<br />
for next year’s event. Show<br />
increase over last year’s rebookings.<br />
management is meeting with key<br />
stakeholders and industry participants, as well as committed to investing time and Attendees at this year’s InformexUSA are invited to stop by Informex Booth 1709<br />
resources to insure that the event stays at the forefront of market demands and to learn more about the show in Miami and how they can share their insight and<br />
continues to meet the needs of the industry.<br />
provide feedback on their Informex experience.<br />
Intelligence, Association Partnerships for Industry Success<br />
Informex is committed to working closely with key industry associations and<br />
market research firms to promote the event, as well as foster industry growth<br />
and attendees’ professional development.<br />
With its on-going partnership with SOCMA, InformEx meets with the association<br />
and many of its members throughout the year to ensure Informex is building a<br />
high value and relevant event for the chemical industry. Informex also attends and<br />
supports SOCMA’s events and participates in member activities throughout the year.<br />
Recently, InformEx & PIERS, The Standard in Trade Intelligence, partnered<br />
to create a one-of-a-kind report available for free download that examined top<br />
markets for U.S. chemical exports based on the volume of waterborne shipments.<br />
The report, Market Opportunities for U.S. <strong>Chemical</strong> Exports: An Examination of<br />
Growth Across Major Markets, examined top markets for U.S. chemical exports<br />
classified under chapters 28 & 29 of the harmonized tariff schedule.<br />
In each of these markets, the report provides a macro-assessment of selected<br />
commodities that have shown significant growth between 2007 and 2011 and<br />
are traded in relatively high volume. The report was designed to give chemical<br />
manufacturers, distributors, end users, and those servicing the chemical supply<br />
chain, a high-level of view of top markets based on aggregate data for U.S.<br />
chemical exports.<br />
At the show this year, Informex partnered with BIOCOM, the largest regional life<br />
science association in the world, representing more than 550 member companies in<br />
Southern California. The association focuses on initiatives that positively influence<br />
the region’s life science community in the development and delivery of innovative<br />
products that improve health and quality of life. Its members where invited to<br />
attend Informex and benefit from the networking, sourcing, and educational<br />
opportunities that are presented here.<br />
Informex also works with the <strong>Chemical</strong> Educational Foundation to promote and<br />
enhance science education among every generation.<br />
RX-360 and Green Chemistry Institute of the <strong>American</strong> <strong>Chemical</strong> Society help to<br />
develop content and foster industry collaboration and awareness.<br />
In the coming year, Informex will be working with even more associations and<br />
content providers to extend its reach and best serve the needs of the industry.<br />
P u b l i s h e d b y A m e r i c a n C h e m i c a l S o c i e t y<br />
Publisher Kenneth M. Carroll<br />
Editor Sharon Donovan<br />
Reporter Ilene Schneider<br />
Art Director Connie Hameedi<br />
Photographers Peter Cutts<br />
Advertising Sales USA<br />
Dean Baldwin, Robert LaPointe,<br />
Thomas Scanlan<br />
Europe Uwe Riemeyer,<br />
Paul Barrett, Nadia Liefsoens<br />
Asia Minghua Lu, Angel Zu,<br />
Mai Hashikura, Shigamaro Yatsui,<br />
Faredoon Kuka<br />
Production Manager<br />
Joseph Davis<br />
ACS Publications<br />
Advertising Sales Group<br />
480 East Swedesford Road<br />
Wayne, PA 19087<br />
Phone 610.964.8061/Fax<br />
610.964.8071<br />
http://cen.acs.org/onsite.html
4 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
Part 2: Showcases Highlight Company Strengths, Growth<br />
Editor’s Note: This roundup of InformexUSA Showcases is a Part 2 followup to<br />
Tuesday’s presentations aimed at briefing attendees on companies’ most recent<br />
developments within the industry. More showcase coverage will appear in the<br />
InformexUSA Show Daily wrap edition.<br />
Catalent is into heavy metal<br />
Michelle Cree, a senior scientist at Catalent<br />
Pharma Solutions, discussed new regulatory<br />
expectations and solutions related to toxic<br />
metals in the harmaceutical supply chain.<br />
She related that pharmaceutical testing<br />
for elemental impurities in excipients,<br />
API (active pharmaceutical ingredient)<br />
and drug products is necessary to ensure<br />
product quality and consumer safety. USP<br />
General Chapter 231 has been used since<br />
1905 to assess “heavy metal” content in<br />
pharmaceutical products.<br />
Michelle Cree,<br />
The talk discussed the reasons for<br />
senior scientist, Catalent<br />
replacing General Chapter 231 and outlined<br />
the new requirements for USP Elemental Impurities testing as described in General<br />
Chapters 232 and 233. Cree described strategies for compliance with these new<br />
requirements and provided development and validation examples from case studies<br />
performed in Catalent’s laboratories.<br />
Headquartered in Somerset, NJ, the company serves thousands of innovators,<br />
large and small, in more than 100 markets, including 36 of the top 50 biotech<br />
companies and 49 of the top 50 pharmaceutical companies. Catalent employs<br />
9,000 people and its team of more than 1,000 scientists supports 40 percent of<br />
recent new drug approvals.<br />
Chiral Quest announces future direction<br />
Chiral Quest announced its new CEO<br />
James Wu and its merger with Jiang Xi<br />
Long Life Biopharmaceuticals, a commercial<br />
manufacturing plant near Nanchang, in<br />
Jiangxi Province, China.<br />
Chiral Quest is a U.S.-based company<br />
founded in 2000 and Jiangxi Long Life<br />
was founded in 2009. While Chiral Quest<br />
Suzhou is focused on R&D and pilot plant<br />
operations, Chiral Quest Long Life is focused<br />
on commercial scale manufacture. The<br />
combined company has more than 100,000<br />
L of manufacturing capacity, with expertise<br />
Ian Lennon, senior VP, Chiral Quest<br />
in high pressure asymmetric hydrogenation<br />
and cryogenic reactions. The company has successfully developed and scaled<br />
up many processes for the commercial manufacture of both chiral and achiral<br />
intermediates.<br />
Cambrex makes potent statement<br />
Cambrex’s showcase highlighted its custom development and manufacturing<br />
capabilities, including analytical development, process validation, and finished<br />
dosage form manufacture.<br />
John Michnick, associate director of sales and business development, said the<br />
company’s high potency development center provides containment and rigorous controls<br />
to reliably and safely develop and manufacture a wide range of high- and ultra-high<br />
potency APIs and intermediates, including<br />
oncologics and controlled substances.<br />
Globally, Cambrex offers a variety of<br />
technology-driven products and services<br />
that accelerate the development of small<br />
molecule therapeutics from custom<br />
development to commercial manufacturing,<br />
including high potency APIs and drug<br />
intermediates. The company manufactures<br />
more than 120 generic and branded<br />
APIs, as well as advanced pharmaceutical<br />
intermediates. The company’s commitment<br />
John Michnick,<br />
to quality, safety and regulatory compliance<br />
associate director, Cambrex<br />
allows Cambrex to seamlessly support its<br />
clients’ API needs from clinical trials through commercial launch.<br />
Founded in 1981 as CasChem, the company was renamed Cambrex in 1987.<br />
Cambrex entered the pharmaceutical market in 1994 with the acquisition of<br />
Nobel Pharma Chemistry. Through multiple acquisitions during the late 1990s, the<br />
company entered the bioscience and chiral enzymatic catalyst markets.<br />
Senn discusses practical peptide considerations<br />
Senn <strong>Chemical</strong>s highlighted the synthetic<br />
challenges of peptide-based therapeutics<br />
at its showcase. According to Richard<br />
Pariza, peptide-based therapeutics, as well<br />
as peptidiomimetic drugs, present unique<br />
challenges to synthetic chemists. New<br />
reagents and techniques, as well as the<br />
expertise of experienced peptide chemists,<br />
are essential to the research-scale as well as<br />
the manufacturing of these important new<br />
drugs. The session focused on the practical<br />
considerations that can ensure efficiency<br />
and success in biotech/pharma peptide<br />
Richard Pariza, Senn <strong>Chemical</strong>s<br />
manufacturing.<br />
Senn <strong>Chemical</strong>s was founded in 1963 and has been specializing in customized,<br />
cost-effective solutions to a variety of compound, process and manufacturing<br />
challenges. Senn’s cGMP manufacturing facilities, based outside of Zurich,<br />
Switzerland, support its primary development, production and analytical capabilities.<br />
The company currently has offices in Menlo Park and San Diego, California.<br />
Senn <strong>Chemical</strong>s has been providing custom manufacturing services to<br />
pharmaceutical, biotechnology, diagnostic and cosmeceutical companies worldwide.<br />
With specific emphasis on peptides and complex organic molecules, Senn possesses<br />
deep expertise of both development and production.<br />
APC adds value to peptide production<br />
<strong>American</strong> Peptide Company is dedicated to serving the life science community by<br />
providing tools for peptide research. At its showcase presentation APC described<br />
how it offers comprehensive selections of pre-manufactured catalog peptides,<br />
custom synthesis, and GMP peptide active pharmaceutical ingredients.<br />
The company’s California-based manufacturing facilities offer synthesis services<br />
under non GMP (Sunnyvale) and cGMP (Vista) conditions. <strong>American</strong> Peptide’s cGMP<br />
manufacturing is performed under strict adherence to FDA Regulations 21 CFR parts<br />
210, 211 and ICH Guidance Q7A. Its total peptide management services support<br />
clients in the drug development process from pre-clinical through commercial stage.<br />
Value added services include process development, scale up production, analytical/
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 5<br />
process validation, stability studies, CMC, DMF, and regulatory support.<br />
The company’s GMP facilities are designed for large-scale manufacturing of<br />
pharmaceutical drug substances for clinical research. Manufacturing under cGMP<br />
is performed under strict adherence to U.S. FDA regulations CFR 21 parts 210 and<br />
211 and ICH guideline Q7 for Active Pharmaceutical Ingredients. SOPs (Standard<br />
Operating Procedures) are strictly followed and meticulously documented during the<br />
manufacturing process by a trained staff of highly qualified specialists. The company<br />
provides complete documentation and regulatory support for your IND, NDA, and<br />
other regulatory body submissions.<br />
Delmar <strong>Chemical</strong>s is adding capabilities<br />
Headquartered in LaSalle, Quebec, Canada, Delmar specializes in process<br />
development and custom cGMP synthesis of APIs for pharma and biotech clients<br />
that are either developing new drug candidates or that are already marketing<br />
commercial products. In business for more than seventy years, Delmar has<br />
established a reputation as an innovative and experienced company.<br />
Delmar offers its clients a seamless range of integrated development solutions<br />
for every project phase, from discovery, to proof of concept and beyond. Clients can<br />
access Delmar’s full suite of products and services or choose from selected offerings.<br />
The company has the expertise, the technology and the know-how to compress<br />
timelines, maintain quality and reduce the cost of bringing drugs to market on a<br />
global scale.<br />
Delmar has well-equipped process R&D and analytical laboratories, a cGMP pilot<br />
plant and commercial-scale cGMP production capabilities. In addition, Delmar offers<br />
a full range of custom development and manufacturing services including process<br />
development and validation.<br />
Show-at-a-Glance<br />
T h u r s d a y , T o d a y<br />
7:30 am–5:30 pm Registration Open—Lobby C<br />
7:30–10 am Networking Breakfast—Exhibition Floor Hall C & D<br />
8–10 am Morning Conference Sessions—Marriott Anaheim<br />
10–11am Conference Break/Exhibit Time<br />
9 am–5 pm Exhibits Open—Halls C & D<br />
11 am–2 pm Afternoon Conference Sessions—Marriott Anaheim<br />
11:30 am–2 pm Networking Lunch—Exhibition Floor Hall C & D<br />
3–4 pm Informex Speed Networking—Networking Lounge<br />
5–6:30 pm Informex Networking Reception—Lobby D—<br />
Sponsored by C&EN<br />
F r i d a y , F e b r u a r y 2 2<br />
8 am–Noon Registration Open—Lobby C<br />
7:30–10 am Networking Breakfast—Exhibition Floor Hall C & D<br />
9 am–Noon Exhibits Open—Halls C & D<br />
Conference Schedule—Today<br />
All sessions at Marriott Anaheim<br />
8 am<br />
Bio-based <strong>Chemical</strong>s: Going Commercial—Orange County 1<br />
Implementing Green Chemistry Initiatives Through Open Innovation—<br />
Orange County 2<br />
Leaders Need Real-World Crisis Training—Elite Ballroom—Salon 2<br />
Innovations in Formulation, Manufacturing of Emulsions—<br />
Elite Ballroom—Salon 3<br />
9 am<br />
Market Regulation: How It Affects Your Business, How to Fight Back—<br />
Orange County 1<br />
Non cGMP Manufacturing: What I Look for in a Toller—Orange County 2<br />
Attn Suppliers: What Keeps Me Up at Night—How Rx-360 Helps (Me Sleep<br />
Better)—Orange County 3 and 4<br />
Lead Optimization to First in Man Studies—Elite Ballroom—Salon 1<br />
10 am<br />
API Manufacturing in U.S. is Dead—Or Is it<br />
Leaders of U.S.-based API Manufacturers Provide Their Perspectives on the<br />
Present, Future of API Manufacturing in the U.S.—Orange County 3 and 4<br />
11 am<br />
Regulatory, Judicial Extremes: China vs. California—Orange County 1<br />
Hedge Your Bets: Add Market Research to New Product Development<br />
Process—Orange County 2<br />
Monitoring the Biopharmaceutical Raw Material Supply—Elite Ballroom—<br />
Salon 1<br />
Business Valuation and the Exit Planning and Sale-of-Business Process—Elite<br />
Ballroom—Salon 2<br />
Noon<br />
REACh—Preparing for May 30, 2013 and Beyond—Orange County 1<br />
The Secret Language of Influence: Your Passport to Powerful Persuasion—<br />
Orange County 2<br />
Meeting the Challenge of Phase 1 Development of APIs—Elite Ballroom—<br />
Salon 1<br />
Leading Edge Ophthalmic Sensor Technologies for Diabetes Management—<br />
Elite Ballroom—Salon 3<br />
1 pm<br />
Regulatory Challenges, Trends in Finished Dosage Manufacturing: A CMO<br />
Perspective—Orange County 1<br />
Market and Technology Trends in Biopharmaceutical Contract<br />
Manufacturing—Orange County 2<br />
Enhancing Process Economics by Combining Unit Operations—A Global<br />
Approach to the Purification ‘Problem’—Elite Ballroom—Salon 1<br />
Accelerating Innovation Through Strategic Outsourcing—Elite Ballroom—<br />
Salon 2<br />
Structure-Based Sourcing of Research <strong>Chemical</strong>s—Elite Ballroom—<br />
Salon 3
6 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
SOCMA’s Management Services<br />
Sees Growth, Key Advocacy<br />
Results in 2012<br />
Members of the Bulk Pharmaceuticals Task Force met in SOCMA’s Washington, D.C., office to discuss issues important to the pharmaceutical industry,<br />
among them the Generic Drug User Fees, which the task force was successful in advocating and seeing it become law in 2012.<br />
SOCMA’s Association Management Services (AMS), a group of affiliated<br />
associations and consortia that address specific issues of interest to the<br />
chemical industry, welcomed two new members and saw continued growth<br />
among existing members and key results from their advocacy efforts that will lead to<br />
a safer drug supply chain.<br />
One of the most significant accomplishments of the year came from the AMS<br />
affiliate, the Bulk Pharmaceuticals Task Force, which finalized negotiations with the<br />
Food and Drug Administration on a bill including Generic Drug User Fees. The FDA<br />
Safety and Innovation Act makes it possible for the federal government to speed<br />
approval of lifesaving medicines, reduce drug shortages, and improve the quality<br />
and availability of drugs in the U.S.<br />
AMS also managed four different testing consortia in 2012 in response<br />
to the Environmental Protection Agency’s (EPA) Toxic Substances Control Act<br />
(TSCA) Section 4 test rules for High Production Volume (HPV) chemicals. “We are<br />
anticipating another HPV test rule in 2013 with more chemicals to be tested,” said<br />
Dr. Tucker Helmes, managing director of AMS. “This will allow us to set up new<br />
testing consortia, which we enjoy managing.”<br />
AMS kicked off 2012 by welcoming the Flexible Vinyl Alliance (FVA), which<br />
promoted the wide-ranging uses for flexible vinyl, inclusive of automotive, roofing,<br />
flooring, and medical applications. FVA was visible in efforts to educate and inform<br />
policy makers at both the state and federal levels on the economic and utility of<br />
vinyl—a $20 billion U.S. industry.<br />
SCD-iBIO, a group aiming to advance the commercialization of industrial<br />
biotechnology, was also launched in 2012. It gives member companies an<br />
opportunity to share best practices, have access to educational opportunities,<br />
and take part in networking functions, held its First International Forum:<br />
Commercializing Global Green at the <strong>Chemical</strong> Heritage Foundation (CHF) in<br />
November. Because of the success of the first event, a second forum will be held in<br />
November 2013 at CHF.<br />
The Bio-Process Systems Alliance saw increases in 2012 in both numbers<br />
and influence, as the market for disposable bio-processing platforms utilizing<br />
plastics-technologies continued to expand. BPSA saw growth not only in the<br />
adoption of single-use technologies in the biotechnology sectors, but also in<br />
the adoption of single-use in traditional bio-based drug manufacture, as more<br />
pharmaceutical companies focus on “personalized” medicines that require more<br />
flexible, economical, and discrete manufacturing platforms. BPSA has grown from<br />
a membership base of 38 companies when it first aligned with SOCMA in 2009 to<br />
nearly 50 corporate members as of 2012. Visit SOCMA at Booth 2357.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 7<br />
Members Reaping Benefits from ChemStewards Program<br />
These days, it is imperative that<br />
products to big multi-national chemical<br />
chemical companies have systems,<br />
companies.<br />
practices and procedures in<br />
“Our members’ customers are<br />
place to safely and effectively operate<br />
recognizing the value of ChemStewards<br />
in a manner that protects and gains<br />
and are including the program in their<br />
the confidence of stakeholders. In just<br />
customer audit preferences,” Jordan said.<br />
eight years, SOCMA’s ChemStewards<br />
“This cuts down the paperwork for our<br />
program has gained a reputation as an<br />
members by more than 50 percent.”<br />
efficient and highly effective management<br />
Some 50 SOCMA members are also<br />
system for batch, custom, and specialty<br />
taking advantage of a discount on insurance<br />
manufacturers.<br />
rates from AIG. In addition to crediting<br />
As an industry-developed<br />
verification costs, AIG offers participants a<br />
environmental, health, safety, and security<br />
number of benefits, including underwriting<br />
program based on a three-tier system<br />
risk management credits on policy<br />
with key performance requirements per<br />
premiums for the successful completion of<br />
tier, it is the only management system<br />
ChemStewards audits.<br />
that is totally facility based and provides SOCMA member Dixie <strong>Chemical</strong> employees show their ChemStewards pride with arm This year, the program will focus<br />
patches on their uniforms.<br />
participants with adaptability to conform<br />
greater attention on process and<br />
while still maintaining high standards for compliance.<br />
occupational safety, Jordan said. On May 22, ChemStewards will host the National<br />
ChemStewards managing director Dr. J. Holland Jordan says the program is <strong>Chemical</strong> Safety Symposium in Houston, TX. National and local authorities on<br />
helping companies bolster safety and security at their facilities while improving process and occupational safety will present the latest trends and methodologies<br />
their bottom line. Currently, 98 percent of participants are in compliance with the used to create a safe and secure manufacturing environment. Dr. M. Sam Mannan,<br />
program’s requirement.<br />
director of the Mary K. O’Connor Process Safety Center at Texas A&M University,<br />
“Our members are starting to see the payoff from a safety standpoint as well as will be the keynote speaker. An expert industry panel will discuss new techniques<br />
a business standpoint,” said Jordan.<br />
designed to address plant safety. Also, ChemStewards staff will address best<br />
As specialty chemical makers, ChemStewards participants typically supply<br />
practices in the area of process and occupations safety.
8 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
LIST’s Dry Processing Technology<br />
Reduces Plant Size, Cuts Energy Consumption<br />
LIST USA focuses on processes that operate without the<br />
use of solvents, or processing in the concentrated phase.<br />
It develops and industrializes solutions for the chemical,<br />
polymer, food, and fiber industries that are setting new<br />
standards for modern, efficient and sustainable processing.<br />
Its Dry Processing technology enables customers to be more<br />
competitive by avoiding or greatly reducing the need to buy,<br />
handle, and recycle solvents. It reduces plant size and cuts<br />
energy consumption—shrinking capital and operating costs.<br />
The benefits of LIST Dry Processing include: high continuous<br />
production capacities, high degree of processing flexibilities—<br />
changing grades, changing processing parameters; and high<br />
efficiency operation—maximization of process yield to process<br />
volume, energy savings. It also has ecological benefits with low<br />
emissions and economical advantages with energy savings, low<br />
maintenance, reduced utilities, fewer process steps and smaller<br />
footprint. Due to its high product quality, there is no overheating,<br />
side reactions, or contamination with degraded product.<br />
Founded in 1966 by Heinz List, a pioneer of modern industrial processing<br />
technology, LIST’s experience spans 45 years, including thousands of trials with a<br />
broad range of products, and hundreds of successfully executed industrial-scale<br />
installations.<br />
LIST technology also provides health, safety and environmental benefits—<br />
reducing CO2 emissions, eliminating solvents, and increasing safety through precise<br />
thermal management.<br />
LIST’s focus on innovation, backed by a commitment to research and<br />
development, is evident with an expansion and modernization of their testing<br />
facility. The expansion includes a new customer center featuring a pilot-scale, fullyautomated,<br />
proof-of-concept system to demonstrate their two-stage continuous<br />
process. These additions increase the process testing capabilities available to<br />
customers, providing the ability to conduct feasibility studies, process optimization,<br />
and scale-up evaluation, among many other things.<br />
Visit LIST at Booth 2419.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 9<br />
Five Minutes With…<br />
Denis Geffroy<br />
Vice President of Business Development<br />
Almac<br />
Among the challenges the industry<br />
faces, which do you think are the<br />
most pressing<br />
There continues to be an ongoing<br />
funding challenge for pharmaceutical<br />
development. Increasing complexity of<br />
treatments, combined with increase safety<br />
testing, and increased price controls, creates<br />
a major challenge in developing a profitable drug. Although the science continues<br />
to advance, we are reaching a stage at which funding development of life-saving<br />
treatments may become unsustainable. Creative solutions for cost control are being<br />
implemented throughout the industry.<br />
And what do you believe are the most creative solutions<br />
Partnerships and collaborations are being implemented to take advantage of<br />
strengths of various organizations. Big pharma is partnering with academics (for<br />
example, decisions by Pfizer and Novartis among others, to move drug discovery<br />
to Cambridge, MA to take advantage of proximity to academic excellence) and<br />
BioTechs to increase the efficiency and reduce cost and timelines of early drug<br />
development. Big pharma seems to have finally embraced outsourcing of significant<br />
CMC work as a way to reduce overhead and costs. These two strategies have<br />
provided opportunities and challenges to CMOs and CROs. Although development<br />
pipelines have been slashed, increased outsourcing has kept the flow of CMC<br />
development work reasonably healthy.<br />
Although ‘one stop shop’ has carried significant negative connotations in our<br />
industry for many years, the reality is that an efficient offering of related services<br />
applied throughout the development cycle from a single provider has been shown<br />
to result in significant efficiencies in both time and cost savings. The key element<br />
is that the provider of the related services must operate a near seamless process of<br />
delivering these services.<br />
For example, at Almac a project can enter our business at the earliest phase<br />
of development and benefit from chemical development and physical form<br />
optimization (both salt and / or polymorph), analytical methods development and<br />
biomarker or companion diagnostic development. Undertaking these early clinical<br />
development activities can also help to reduce attrition rate – common for many<br />
new compounds. As the compound advances into clinical trials, biocatalysis might<br />
be employed to greatly improve the manufacturing process. The early formulation<br />
can be quickly and efficiently developed and GMP supplies of API and Drug Product<br />
supplied. During clinical development a radiolabeled API and DP can be provided<br />
for ADME studies and the API process and formulation can be further refined and<br />
scaled-up. The clinical product can be packaged, labeled and distributed worldwide<br />
using sophisticated Drug Supply Management programs and Interactive Voice/<br />
Web Response Systems (IXRS). Finally, the process and analytical methods will<br />
be validated, and ultimately commercial quantities manufactured, packaged and<br />
See 5 Minutes With…Almac page 15
10 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
Organic Technologies Posts<br />
Positive Business Outlook Based on Expanding Product Mix<br />
Organic Technologies begins<br />
2013 with an expanding product<br />
mix and planned capacity<br />
increases. The Coshocton, OHbased<br />
fine chemicals producer<br />
and custom manufacturer comes<br />
to Informex with a positive<br />
business outlook and an interest<br />
in featuring new product growth<br />
areas.<br />
The privately held firm, formerly known in the industry as Wiley Organics, has<br />
grown beyond its historical catalog business and now focuses on four key areas:<br />
food and nutritional ingredients, fine chemicals and specialty gas components, toll<br />
distillation and custom manufacturing.<br />
CEO and President David B. Wiley noted that Organic Technologies’ diversity<br />
of product mix is unusual but purposeful: “As a company with experience in both<br />
synthetic chemistry and separations, we saw a unique opportunity to produce a<br />
fully <strong>American</strong> sourced and manufactured omega-3 product to the highest purity<br />
and quality standards. This was made possible by our experience in high efficiency<br />
distillation and other purification techniques.”<br />
In fiscal year 2012, sales revenue hit a record level and employment increased by<br />
about 12 percent, as validation of the company’s strategy.<br />
The functional food area has been accompanied by growth in the fine chemicals and<br />
specialty gas components business. Jack Etheridge, VP, cited three specific developments:<br />
“First, we have been able to step in and supply some products no longer<br />
supplied by larger firms. Secondly, we are producing higher purity items, especially<br />
specialty gas components. Thirdly, we are increasing our scale of production of certain<br />
acetylenics, such as 1-butyne.”Visit Organic Technologies at Booth 1247.<br />
PharmaCore’s In-House Analytical Chemistry<br />
Department Supports Scale-Up Projects<br />
PharmaCore GMP Analytical believes that it is critical to focus on supporting<br />
projects from the ground up. PharmaCore’s team of analytical scientists interfaces<br />
directly with scientists and process chemists from the start of each project.<br />
From testing incoming raw materials against strictly controlled standards, through<br />
in-process and intermediate testing support, to GMP release of final product—and<br />
beyond, to qualification of Reference Standards and in-house support to ICH Stability<br />
Studies—PharmaCore’s GMP analytical laboratory provides support to all projects.<br />
With more than 100 years of combined pharmaceutical experience, the lab<br />
now employs six full-time analytical chemists and supports all phases of in-house<br />
contract API production from eight separate production suites. The recently<br />
expanded 40,000 sq. ft. facility has the capability to produce 50+ Kg batch sizes<br />
for materials in phases up to and including Phase 3.<br />
PharmaCore’s pharmaceutical analytical services also are available on a contract<br />
basis. In this vein, PharmaCore’s GMP analytical laboratory focuses on the API arena<br />
and provides expertise in and support for: analytical methods development, validation<br />
(including Residual Solvents), and transfer; cleaning validation; and consultation<br />
Visit PharmaCore at Booth 1508.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 11<br />
Five Minutes With…<br />
Stewart<br />
Tipson<br />
Vice President<br />
DrM<br />
What are your major<br />
concerns within your<br />
market over the next two<br />
years<br />
Maintaining a balance<br />
between current production<br />
output efficiency, longterm<br />
economic benefits and<br />
sustainable environmental and<br />
personnel protection. Some<br />
new or emerging technologies<br />
for fine chemical, biotech and<br />
energy try to use an older<br />
antiquated technology due to convenience. There seem to be too many low cost<br />
fixes that do not address the problem but rather fix a symptom.<br />
engineered solutions are simple rubber-stamped or “boiler plate” processes that do<br />
not always have the most efficient operating and reliability characteristics of well<br />
planned solution. Tight time constrains and budgets can limit what is available to<br />
the client.<br />
And what do you believe are the most creative solutions<br />
The most creative solutions are ones that address multiple concerns in one<br />
elegant design. Often these innovations involve planning ahead with scalable<br />
laboratory testing, finding innovative products and solutions to meet more stringent<br />
quality requirements or regulations.<br />
What should be the common goals within the industry and/or<br />
marketplace<br />
Balancing short term goals and long term solutions. Often the tendency due<br />
to short term cost factors is for replication of existing processes that often are not<br />
able to adequately meet new quality or regulatory requirements over the long term.<br />
When stringent cost analysis is undertaken it is often shown that investment in<br />
technology today will ultimately result in a larger pay back over time. The culture<br />
of purchasing to meet the needs of today needs to be addressed and a more<br />
balanced approach taken to select the most relevant technology for the long-term<br />
requirements.<br />
Among the challenges the industry faces, which do you think are<br />
the most pressing<br />
Finding value-based solutions through the education of the client. Some<br />
DrM is an international leader in providing filtration systems for solid/liquid<br />
separation in the processing industries for the past 30 years.
2Y-Chem, Ltd, Booth 2405<br />
Aaron Equipment Company, Booth 1424<br />
Aarti Industries Ltd, Booth 1660<br />
ABA <strong>Chemical</strong>s Corp, Booth 2033<br />
ABCR GmbH & Co KG<br />
Ace Glass, Booth 1913<br />
ACES Pharma Inc, Booth 2043<br />
Aceto Corporation, Booth 1201<br />
Acoris Research Ltd, Booth 2410<br />
ACS Green Chemistry Institute, Booth 1044<br />
Adesis Inc, Booth 1420<br />
Advance Research <strong>Chemical</strong>s, Inc, Booth 2532<br />
Advanstar Communications, Booth 1053<br />
AGC <strong>Chemical</strong>s Americas Inc, Booth 1612<br />
Agno Pharma, Booth 2006<br />
Air Liquide Electronics, U.S.L.P, Booth 2415<br />
Albemarle Corporation, Booth 1430<br />
Alfa Aesar, a Johnson Matthey Company, Booth 2310<br />
AllessaChemie GmbH, Booth 2101<br />
AllyChem Co, Ltd, Dalian China, Booth 1408<br />
Almac Group ltd, Booth 1313<br />
Alphora Research Inc, Booth 1406<br />
Altiras Industrial Services, Booth 1529<br />
Alzchem LLC, Booth 1909<br />
Amano Enzyme USA Co Ltd, Booth 2430<br />
AmbioPharm, Inc, Booth 1158<br />
<strong>American</strong> Custom Drying Co, Booth 1301<br />
<strong>American</strong> Peptide Company Inc, Booth 1418<br />
AminoLogics Co Ltd, Booth 2059<br />
Ampac Fine <strong>Chemical</strong>s, Booth 2257<br />
Ampac Fine <strong>Chemical</strong>s, Booth MR26<br />
AMRI, Booth 1001<br />
Amsyn Inc, Booth 1307<br />
Anthem Biosciences Pvt Ltd, Booth 2201<br />
APC Ltd, The Applied Process Company, Booth 2056<br />
Apollo Scientific, Booth 2161<br />
Apotex Fermentation, Inc, Booth 1344<br />
Aptuit, Booth 1619<br />
ARRAN <strong>Chemical</strong> Co, Booth 1639<br />
Artisan Industries Inc, Booth 1021<br />
Ash Stevens, Inc, Booth 1552<br />
Ash Stevens, Inc, Booth MR7<br />
A-Star <strong>Chemical</strong> Co, Ltd, Booth 1219a<br />
Astatech, Inc, Booth 1011<br />
Asymchem Laboratories (Tianjin) Co, Ltd, Booth 2138<br />
Asymchem Laboratories (Tianjin) Co, Ltd, Booth MR25<br />
Aurora Filters, Booth 1150<br />
Austin <strong>Chemical</strong> Company, Inc, Booth 1225<br />
BASF Corporation, Booth 1439<br />
BASF Corporation, Booth MR3<br />
BCN Peptides SA, Booth 1029<br />
Beijing Century RICHAP Chemistry Co, Ltd,<br />
Booth 1359<br />
Beijing Laviana Pharmatech Co, Ltd, Booth 2124<br />
Beijing Odyssey <strong>Chemical</strong>s Co, Ltd, Booth 2009<br />
Beijing Tianqing <strong>Chemical</strong>s.Co,Ltd, Booth 2015<br />
Benzo Chem Industries Pvt. Ltd, Booth 2423C<br />
Bharavi Laboratories, Booth 921H<br />
Biazzi SA, Booth 1758<br />
BioReliance Corporation, Booth 921L<br />
Biovectra Inc, Booth 2156<br />
Boehringer Ingelheim Pharma GmbH & CoKG,<br />
Booth 2351<br />
Boron Molecular USA, Booth 1421<br />
Boron Specialties LLC, Booth 1608<br />
Borregaard Synthesis, Booth 1038<br />
Boulder Scientific Company, Booth 1309<br />
Browz, LLC, Booth 1620<br />
Buchiglas USA Corp, Booth 2301<br />
Buckman Laboratories, Booth 1912<br />
C&EN/ACS Publications, Booth 2447<br />
CABB AG, Booth 2350<br />
CAC <strong>Chemical</strong> Co Ltd, Booth 1533<br />
CalaChem Ltd, Booth 1119<br />
Calaire Chimie S.A.S., Booth 1501<br />
Cambrex Corporation, Booth 1539<br />
Cambrex Corporation, Booth MR2<br />
Cambridge Major Laboratories, Booth 2225<br />
CAP Intelligence, Booth 2260<br />
CARBOGEN AMCIS AG, Booth 2529<br />
CARBOGEN AMCIS AG, Booth MR36<br />
Carbosynth Ltd, Booth 2423E<br />
Cardolite Corporation, Booth 2221<br />
Carus Corporation, Booth 2423D<br />
CAS, Booth 1009<br />
Catalent Pharma Solutions, Booth 2414<br />
CatSci, Booth 921C<br />
CCPIT Sub-Council of <strong>Chemical</strong> Industry, Booth 1521<br />
CCR Containers, Booth 1355<br />
Cedarburg Pharmaceuticals Inc, Booth 1207<br />
Cedarburg Pharmaceuticals Inc, Booth MR5<br />
CellMark <strong>Chemical</strong>s, Booth 1258<br />
Centauri Technologies LP, Booth 1658<br />
Central Glass International, Inc, Booth 2157<br />
Changzhou EST <strong>Chemical</strong> Co Ltd, Booth 1459<br />
Changzhou Sunlight Fine <strong>Chemical</strong> Co,Ltd, Booth 2011<br />
Charkit <strong>Chemical</strong> Corporation, Booth 1649<br />
CHEM Group, Inc, Booth 1746<br />
Chemada / ICL-IP, Booth 1561<br />
ChemCon GmbH, Booth 1501<br />
ChemDesign Products, Inc, Booth 1603<br />
ChemFuture PharmaTech (Jiangsu) Ltd, Booth 2144<br />
Chemglass Life Sciences, Booth 2409<br />
<strong>Chemical</strong> Week, Booth 1946<br />
<strong>Chemical</strong>s Incorporated, Booth 1957<br />
CHEMIK Co, Ltd, Booth 1402<br />
Chemindustry.com, Inc, Booth 2028<br />
Chemlex Pharmaceuticals LLC, Booth 2445<br />
ChemNexus Inc, Booth 2230<br />
Chemoswed, Booth 2201<br />
Chempacific Corporation, Booth 1907<br />
Chemspec API Corp., Booth 2450<br />
Chemtura Corp., Booth 1548<br />
Chevron Phillips, Booth 1712<br />
Chifeng Yingfa Pharmaceutical Co, Ltd, Booth 1128<br />
China Chamber of Commerce of Med. & Heal,<br />
Booth 1147a<br />
China National Pharmaceutical Foreign Co,<br />
Booth 2446<br />
Chiral Quest Inc, Booth 1522<br />
Chiral Technologies, Inc, Booth 2432<br />
Chiral Technologies, Inc, Booth MR27<br />
CiNet, Booth 1626<br />
CiVentiChem, LLC, Booth 2153<br />
Clean Harbors Environmental Services, Inc, Booth 1354<br />
Colonial Metals Inc, Booth 2047<br />
CompareNetworks Inc, Booth 1048<br />
Contract <strong>Chemical</strong>s Ltd, Booth 1447<br />
Corden Pharma International GmbH, Booth 1801<br />
Corning SAS, Booth 933<br />
CorsiTech, Booth 2331<br />
COSMOSS VU Ltd, Booth 2110<br />
CRI, Booth 1644<br />
Crystallics BV, Booth 1252<br />
CU Chemie Uetikon GmbH, Booth 1545<br />
Custom Granular, Inc, Booth 1407<br />
Cymer, LLC, Booth 1744<br />
Dae Hwa Pharmaceutical Co, Ltd, Booth 1047<br />
Daewoong Bio Inc, Booth 1144<br />
Dalchem, Booth 2444<br />
Dalian Joinking Bio<strong>Chemical</strong> Tech Co, Ltd,<br />
Booth 1249<br />
Dalian Richfortune <strong>Chemical</strong>s Co, Ltd, Booth 1206<br />
DanChem Technologies, Inc, Booth 2012<br />
Danyang Wanlong <strong>Chemical</strong> Co,Ltd, Booth 1214<br />
DavosPharma, Booth 2201<br />
DCAT (Drug, <strong>Chemical</strong> & Associated Tech,<br />
Booth 1947<br />
Deepwater <strong>Chemical</strong>s Inc, Booth 1461<br />
DELMAR <strong>Chemical</strong>s INC, Booth 2049<br />
Digital Specialty <strong>Chemical</strong>s, Booth 1160<br />
Dishman USA, Booth 2531<br />
Dixie <strong>Chemical</strong> Company, Inc, Booth 2231<br />
Dottikon Exclusive Synthesis AG (USA), Booth 2119<br />
Dr. M Inc, Booth 1758<br />
Dr. Reddy’s Laboratories Ltd, Booth 1901<br />
Drug Development & Delivery, Booth 1010<br />
DSL <strong>Chemical</strong>s (Shanghai) Co, Ltd, Booth 1546<br />
DSM Pharmaceutical Products Inc, Booth 1401<br />
DyStar L.P., Booth 1926<br />
Eastar <strong>Chemical</strong> Corp., Booth 2133<br />
eChinaChem, Inc, Booth 1948<br />
Enzyme Works Inc , Booth 2423B<br />
Enzymicals AG, Booth 1014<br />
Equinox <strong>Chemical</strong>s, LLC, Booth 1748<br />
Esteve Quimica, S.A., Booth 2238<br />
Euticals, Inc, Booth 1633<br />
Euticals, Inc, Booth MR6<br />
Evonik Degussa Corp, Booth 1239<br />
Evonik Degussa Corp, Booth MR8<br />
Exova, Booth 1119<br />
F.I.S.–Fabbrica Italiana Sintetici SpA, Booth 2049<br />
F.I.S.–Fabbrica Italiana Sintetici SpA, Booth MR28<br />
Far <strong>Chemical</strong>, Inc, Booth 1139<br />
Fareva, Booth 2046<br />
Farmabios SpA, Booth 1253<br />
Farmhispania S.A., Booth 1259<br />
Federal Equipment, Booth 2030<br />
Fermion Oy, Booth 2231<br />
Ferro Pfanstiehl Laboratories, Booth 2232<br />
Flamma Spa, Booth 1802<br />
FMC Lithium, Booth 1438<br />
Fontarome <strong>Chemical</strong> Inc, Booth 1351<br />
Frau Pharma srl, Booth 921O<br />
Fuji <strong>Chemical</strong> Industry Co, Ltd, Booth 1654<br />
Fuji Silysia <strong>Chemical</strong> Ltd, Booth 2347<br />
FutureFuel <strong>Chemical</strong> Co, Booth 1653<br />
Fuzhou Sanhe Pharmachem Co, Ltd, Booth 1618<br />
Gabriel Performance Products, Booth 1423<br />
Galbraith Laboratories Inc, Booth 1002<br />
Gelest Inc, Booth 1318<br />
GFS <strong>Chemical</strong>s Inc, Booth 1930<br />
GL Filtration Ltd, Booth 1150<br />
Grace/Synthetech, Booth 2039<br />
Gran Formosa Inc, Booth 921P<br />
Guangzhou Runhua Food Additive Co, Ltd, Booth 2244<br />
GVK Biosciences Pvt. Ltd, Booth 1509<br />
Halocarbon Products Corp, Booth 1155<br />
Hamari <strong>Chemical</strong>s Ltd, Booth 2401<br />
Haviland Products Co, Booth 2061<br />
Hebei Chengxin Co, Ltd, Booth 2128<br />
Helsinn Advanced Synthesis SA, Booth 1809<br />
Helsinn Advanced Synthesis SA, Booth MR9<br />
HERBRAND Pharma<strong>Chemical</strong>s GmbH, Booth 1014<br />
Heritage Environmental Services, Booth 2424<br />
Hodogaya <strong>Chemical</strong> (USA) Inc, Booth 1261<br />
Hongye <strong>Chemical</strong> Co, Ltd, Booth 2108<br />
Hopax Tawain <strong>Chemical</strong> Mfg, Booth 1015<br />
Hovione, LLC, Booth 2330<br />
Huaian MDC Pharmaceutical Co, Ltd, Booth 1120<br />
Hubei Greenhome Fine <strong>Chemical</strong> Co, Ltd, Booth 2248<br />
Hydrite <strong>Chemical</strong> Co, Booth 1610<br />
ICO Polymers North America, Booth 1621<br />
InChem Corp, Booth 1652<br />
InCon Processing, LLC, Booth 1613<br />
Ind Swift Laboratories Ltd, Booth 1960<br />
Indoco Remedies Ltd, Booth 2253<br />
Indofine <strong>Chemical</strong> Company Inc, Booth 2206<br />
INFA Group SpA, Booth 1225<br />
Informex Global Pharma Sourcing, Booth 1709<br />
Informex Sales Booth, Booth 1709<br />
Informex Specialty <strong>Chemical</strong> Forum, Booth 1709<br />
Ingenza Ltd, Booth 1119<br />
Insight High Technology Co, Ltd, JiangSu, Booth 2122<br />
Interchem Corporation, Booth 1501<br />
International Process Plants (IPP), Booth 1908<br />
Iofina <strong>Chemical</strong> Inc, Booth 2333<br />
IRIX Pharmaceuticals Inc, Booth 1813<br />
IRIX Pharmaceuticals Inc, Booth MR10<br />
IRIX Pharmaceuticals Inc, Booth MR11<br />
ISOCHEM, Booth 1738<br />
Italian Trade Commission, Booth 1705<br />
J&W Pharmlab, Booth 1027<br />
Jan Ramakers Fine <strong>Chemical</strong>s Consulting, Booth 1119<br />
Jiangsu Huifeng Agrochemical Co, Ltd, Booth 2001<br />
Jiangsu Lanfeng Biochemical Co, Ltd, Booth 2104<br />
Jiangsu Medicines & Health Prod. I&E Gro, Booth 2005<br />
Jiangxi Renming Pharmaceutical Co, Ltd, Booth 2023<br />
Jiangxi Time <strong>Chemical</strong> Co, Ltd, Booth 1147a<br />
Jinhong Fine <strong>Chemical</strong>s, Booth 1361<br />
Johann Haltermann Ltd, Booth 2307<br />
Johnson Matthey, Booth 2310<br />
Johnson Matthey, Booth 2311<br />
Johnson Matthey Catalysis and Chiral, Booth 2311<br />
J-Star Research, Inc, Booth 1343<br />
J-Star Research, Inc, Booth MR12<br />
Julabo USA, Inc, Booth 1559<br />
Kalexsyn, Inc, Booth 1552<br />
Kingchem Inc, Booth 1450<br />
Kingfirst <strong>Chemical</strong> (Nanjing) Co, Ltd, Booth 2246<br />
KMCO Inc, Booth 1929<br />
Kodak Specialty <strong>Chemical</strong>s, Booth 1742<br />
Lacamas Laboratories Inc, Booth 2325<br />
Lacamas Laboratories Inc, Booth MR13<br />
Laohekou Jinghong <strong>Chemical</strong> Co, Ltd, Booth 1628<br />
LAUDA-Brinkmann, LP, Booth 1607<br />
Laurus Pvt. Ltd, Booth 1924<br />
Laviana Corp, Booth MR23<br />
LCI Corporation, Booth 2247<br />
Lianhe <strong>Chemical</strong> Technology Co, Ltd, Booth 1413<br />
Lishui Nanming <strong>Chemical</strong> Co, Ltd, Booth 2112<br />
LIST USA Inc, Booth 2419<br />
LOBA Chemie PVT Ltd, Booth 2024<br />
Lonza, Booth 1052<br />
Lonza, Booth MR15<br />
Lonza, Booth MR16<br />
Louisiana <strong>Chemical</strong> Equipment Co, Booth 1345<br />
Louston International Inc, Booth 1700<br />
Lundbeck Pharmaceuticals Italy SpA, Booth 1800<br />
Manchester Tank & Equipment Company, Booth 1153<br />
McGean,Inc, Booth 1511<br />
Metallix,Inc, Booth 1448<br />
MFG <strong>Chemical</strong>, Inc, Booth 2438<br />
Micromacinazione SA, Booth 1225<br />
Micron Technologies, Booth 2418<br />
Minakem, LLC, Booth 2320<br />
Mitrychem, Booth 1919<br />
Mitsubishi International PolymerTrade, Booth 2500<br />
Mitsui & Co (USA), Inc, Booth 2321<br />
Mitsui & Co (USA), Inc, Booth MR29<br />
Molekula Group, LLC, Booth 2423G<br />
Monomer-Polymer & Dajac Labs, Booth 2045<br />
Morre-tec Industries, Inc, Booth 2107<br />
MP Biomedicals LLC, Booth 1953<br />
MRIGlobal, Booth 1314<br />
MSU Bioeconomy Institute, Booth 2142<br />
Muller Group, Booth 1961<br />
Na Fluorochem(H.K) International Co, Li, Booth 1521<br />
Nagase & Co, Ltd, Booth 2411<br />
Nanjing Pharmatechs, Co, Ltd, Booth 2208<br />
Nantong Kaixin Pharma <strong>Chemical</strong> Co, Ltd, Booth 1622<br />
Nation Ford <strong>Chemical</strong> Co, Booth 1518<br />
Navin Fluorine International Ltd, Booth 1409<br />
Neuland Laboratories, Booth 1159<br />
Newreka Green & Synth Technologies Pvt.,<br />
Booth 2423F<br />
Niels Clauson-Kaas A/S, Booth 2201<br />
Norac Pharma, Booth 1039<br />
Noramco, Inc, Booth 1143<br />
Norquay Technology Inc, Booth 1032<br />
Northeast Pharmaceutical Group Co, Ltd, Booth 2100<br />
Nova Molecular Technologies, Inc, Booth 1442<br />
Novasep Inc, Booth 1939<br />
Oakwood Products Inc, Booth 1109<br />
Olon Spa, Booth 1703<br />
OmegaChem, Booth 1023<br />
ONYX Scientific, Booth 1910<br />
Optima <strong>Chemical</strong> Group, LLC, Booth 1639<br />
Organic Technologies, Booth 1247<br />
Ortec Inc, Booth 1238<br />
Panjin Xingfu <strong>Chemical</strong> Industrial Co, L, Booth 1553<br />
Parchem Fine & Specialty <strong>Chemical</strong>s, Booth 2240<br />
Patheon, Booth 1107<br />
Paul O Abbe, Booth 1424<br />
PCAS, Booth 1601<br />
PCAS, Booth MR14<br />
PCI Synthesis, Booth 1059<br />
Pennakem, Booth 2318<br />
PepTech Corp, Booth 2057<br />
Perry Videx LLC, Booth 2327<br />
Pharmachem, Booth 2251<br />
Pharmacore, Inc, Booth 1303<br />
Pharmax, Booth 2224<br />
PharmaZell, Inc, Booth 1253<br />
PHT International Inc, Booth 1419<br />
Pierre Fabre Medicaments, Booth 1353<br />
PIERS, Booth 1950<br />
PII Pharmaceutics International Inc, Booth 2426<br />
Piramal Healthcare, Booth 2439<br />
POLAQUIMIA S.A. DE C.V., Booth 1312<br />
Polypeptide Laboratories, Booth 2127<br />
Polysciences Inc, Booth 1242<br />
Pope Scientific Inc, Booth 1254<br />
Porton Fine <strong>Chemical</strong>s Ltd, Booth 1453<br />
Powdersize, Inc, Booth 1215<br />
Pressure <strong>Chemical</strong> Co, Booth 1458<br />
Procos USA (CBC Group), Booth 2226<br />
PYOSA S.A. DE C.V., Booth 1526<br />
Qi-Chem Co Ltd, Booth 1630<br />
Qingdao Union Fine <strong>Chemical</strong> Co Ltd, Booth 1219b<br />
Quanzhou Sanwei <strong>Chemical</strong> Industry Co, L,<br />
Booth 2250<br />
R.S.A. Corporation, Booth 1213<br />
Regis Technologies Inc, Booth 1339<br />
Rhodes Technologies, Booth 1706<br />
Ricerca Biosciences, Booth 2060<br />
Rieke Metals, Inc, Booth 2348<br />
RightAnswer.com, Inc, Booth 1624<br />
Robatel Inc, Booth 1352<br />
Robinson Brothers, Booth 2219<br />
Robinson Pharma, Booth 921G<br />
Rockwood Lithium, Booth 1659<br />
Rodman Publishing, Booth 2146<br />
Rohner Inc, Booth 2215<br />
Rondaxe Pharma LLC, Booth 1648<br />
Ropella, Booth 1346<br />
Rx-360, Booth 2152<br />
SABIC Innovative Plastics, Booth 1449<br />
Sai Life Sciences Ltd, Booth 2109<br />
Sai Life Sciences Ltd, Booth MR24<br />
Saltigo GmbH, Booth 2131<br />
Saltigo GmbH, Booth MR30<br />
SantoLubes Mftg., dba Blackman Uhler,<br />
Booth 1920<br />
SAS Institute Inc, JMP Division, Booth 2443<br />
Scottish Development International, Booth 1119<br />
Scynexis Inc, Booth 2339<br />
Senn, Booth 1058<br />
Senn, Booth MR18<br />
Shaanxi Dasheng Pharmaceutical Tech Co, Booth 1110<br />
Shamrock Technologies, Inc, Booth 2423P<br />
Shandong Hexing Pharmacy Co, Ltd, Booth 1212<br />
Shandong Jiuheng Int’l Trade Co, Ltd, Booth 2252<br />
Shanghai AQBioPharma Co, Ltd, Booth 1141<br />
Shanghai Chemspec Corp., Booth 2450<br />
Shanghai Record Pharmaceuticals Co, Ltd, Booth 2029<br />
Shanghai Shyndec(Modern) Pharmaceutical , Booth 1108<br />
Shanghai Sinofluoro <strong>Chemical</strong>s Co, Ltd, Booth 1631<br />
Shanghai T&W Pharmaceutical Co, Ltd,<br />
Booth 1609<br />
Shenyang Photosensitive <strong>Chemical</strong> Research,<br />
Booth 2126<br />
Shenzhen Nexconn Pharmatechs Ltd, Booth 921K<br />
Shijiazhuang No 4 Pharmaceutical Co, Ltd,<br />
Booth 1114<br />
Shouguang Fukang Pharmaceutical Co, Ltd,<br />
Booth 1147b<br />
Siegfried (USA), Inc, Booth 1101<br />
Silar Laboratories, Booth 2045<br />
Siltech Corporation, Booth 1349<br />
Sinobright Pharmaceutical Company Ltd, Booth 2403<br />
Sinochem Lantian Co, Ltd, Booth 1523<br />
SK Life Science, Inc, Booth 1506<br />
SOCMA, Booth 2357<br />
SOCMA Member Lounge, Booth 2457<br />
Solid Form Solutions Ltd, Booth 1925<br />
Solvay Fluorides LLC, Booth 2239<br />
Solvias Inc, Booth 2211<br />
Spectrum <strong>Chemical</strong> Mfg, Corp, Booth 1944<br />
SSI Chusei, Inc, Booth 2346<br />
SST Corporation, Booth 2231<br />
Strem <strong>Chemical</strong>s Inc, Booth 1319<br />
Sumitomo <strong>Chemical</strong> Europe S.A. / N.V., Booth 2413<br />
Suven Life Sciences USA, Booth 2125<br />
Suzhou Everfortune Imp.&Exp. Co, Ltd, Booth 1246b<br />
Suzhou Highfine Biotech Co, Ltd, Booth 1208<br />
Synasia Inc, Booth 1400<br />
Syngene International, Booth 2050<br />
SynQuest Laboratories, Inc, Booth 2159<br />
SYNTHON <strong>Chemical</strong>s GmbH & Co KG, Booth 1922<br />
T10 <strong>Chemical</strong>s, Booth 921D<br />
Takasago International Corp, Booth 2148<br />
Takasago International Corp, Booth MR33<br />
TCG Lifesciences, Booth 2147<br />
TCI America, Booth 1940<br />
Tekno Scienze SRL, Booth 2412<br />
The <strong>Chemical</strong> Company, Booth 2400<br />
Thomson Reuters, Booth 1000<br />
Tianjin Jingye Fine <strong>Chemical</strong>s Co, Ltd, Booth 2019<br />
TM <strong>Chemical</strong>s LP, Booth 2256<br />
Topharman Shanghai Co, Ltd, Booth 2145<br />
Tosoh USA Inc, Booth 1625<br />
TrustChem Co, Ltd, Booth 2139<br />
Ubichem Pharma Services, Booth 2433<br />
UBM Live, Booth 1709<br />
Umicore AG & Co KG, Booth 1131<br />
United Biochemicals, Booth 1954<br />
Upscale Microwave Inc, Booth 1525<br />
US EPA Green Chemistry Program, Booth 2423i<br />
Valsynthese S.A, Booth 1501<br />
VanDeMark <strong>Chemical</strong>, Inc, Booth 1321<br />
Varsal Inc, Booth 1224<br />
Veolia Environmental Services, Booth 2008<br />
Vertellus Specialties Inc, Booth 1113<br />
Virto/Elcan Industries, Booth 2453<br />
Waterstone Pharmaceuticals Inc, Booth 1558<br />
Weatherford, Booth 1358<br />
Weihai NewEra <strong>Chemical</strong> Co, Ltd, Booth 2258<br />
Western States Machine Corp., Booth 2345<br />
WeylChem Corporation, Booth 1801<br />
WIL Research, Booth 1513<br />
Wilmington Pharma Tech Co, LLC, Booth 1702<br />
Wockhardt Ltd, Booth 1125<br />
WuXi AppTec Inc, Booth 2113<br />
Xi’an Ruilian Modem Electronic <strong>Chemical</strong>s,<br />
Booth 1006<br />
Xiangfan Goto <strong>Chemical</strong> Co, Ltd, Booth 1126<br />
Yangzhou <strong>Chemical</strong> Co ltd, Booth 1527<br />
Yixing Qiancheng Bio-<strong>Engineering</strong> Co, Ltd, Booth 1122<br />
Yizheng City East <strong>Chemical</strong> Co, Ltd, Booth 1112<br />
Zach System S.P.A., Booth 1701<br />
Zepol, Booth 1030<br />
Zhangjiagang Feihang Industry Co, Ltd, Booth 2027<br />
Zhejiang Apeloa Kangyu Pharmaceutical Co,<br />
Booth 1915<br />
Zhejiang Charioteer Pharmaceutical Co, L, Booth 2132<br />
Zhejiang Jianfeng Haizhou Pharmaceutical,<br />
Booth 2319<br />
Zhejiang Medicines & Health Products I/E, Booth 2005<br />
Zhejiang Taizhou Qingquan Medical & Chem,<br />
Booth 2013<br />
Zhejiang Tianyu Pharmaceutical Co, Ltd, Booth 2118<br />
Zhejiang Tongfeng Pharma & Chem. Co, Ltd,<br />
Booth 2025<br />
Zhejiang Yongning Pharmaceutical Co, Ltd ,<br />
Booth 1246a<br />
Zhongdan Group, Booth 1549<br />
Zhong dan Group, Booth MR4
14 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
Nova Molecular Adds<br />
New Distillation Capacity<br />
Nova Molecular Technologies has completed its latest capital expansion project<br />
adding new distillation and reaction capacity at the Pasadena, TX, manufacturing<br />
site. This new capacity will support Nova Molecular’s growth in its current specialty<br />
chemical product portfolio and custom manufacturing business.<br />
In addition to manufacturing capacity onsite, Nova has added strategic<br />
products to its portfolio: 2-Methyltetrahydrofuran, Acetonitrile, and an<br />
amine based line of Epoxy Curing Agents. These products fit well with the<br />
Tetrahydrofuran, Tetrahydrofurfuryl Alcohol, and amine-based products<br />
currently being produced.<br />
To support Nova’s belief in having sound technology behind both<br />
its proprietary and custom products, upgrades to the onsite research<br />
and development lab have been implemented with a quality control lab<br />
expansion planned in 2013. The capabilities of both labs are designed<br />
around being able to support the hydrogenation, pressure reactions, and<br />
fractional distillation unit operations that have become Nova’s specialty. To<br />
complement the labs, the R&D and technical staff have experience and focus<br />
on the implementation of safe, cost effective, and efficient processes.<br />
Nova strives to be an extension to the customer’s supply chain. The<br />
company’s goal starts with the sales and business development team<br />
understanding the needs/goals of each project and product requirements.<br />
This is followed by Nova’s technical staff evaluating and integrating the<br />
process into its facility.<br />
Visit Nova Molecular at Booth 1442.<br />
Ricerca Biosciences Enhances<br />
<strong>Chemical</strong> Development and<br />
Manufacturing Capabilities<br />
Ricerca Biosciences, a U.S.-<br />
based CRO, is committed to<br />
maintaining its reputation as a<br />
supplier of Active Pharmaceutical<br />
Ingredients (APIs) and Specialty<br />
<strong>Chemical</strong>s. This includes<br />
production of material to<br />
support market development<br />
and clinical activities in addition<br />
to commercial supply. The<br />
company’s extensive process chemistry, analytical chemistry, and engineering<br />
expertise provides a synergy that excels at first-time scale-ups and subsequent<br />
development of safe, reliable, robust and cost-effective manufacturing processes.<br />
Meeting the needs of the client has been the foundation of Ricerca’s business<br />
philosophy and is second only to its commitment to safety and regulatory<br />
compliance.<br />
Ricerca continues to strategically increase its chemical development and<br />
manufacturing capabilities to meet the needs of its clients through improved<br />
efficiency and cost-effective delivery of services. Recent upgrades to its plant facility<br />
include the addition of 200- and 400-liter glass-lined steel reaction systems capable<br />
of low-temperature operation. The additional reactor capacity increases the nominal<br />
reactor volume of its cGMP plant facility to 17,000 liters.<br />
Visit Ricerca at Booth 2060.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 15<br />
Umicore Builds a New Facility<br />
for its Precious Metals Chemistry Business Unit<br />
In response to a series of new business<br />
opportunities identified by the U.S. Marketing<br />
and Business Development team,<br />
Umicore’s Precious Metals Chemistry<br />
(PMC) business unit will significantly<br />
expand its manufacturing capabilities by<br />
constructing a new production facility at<br />
the Umicore campus in Tulsa, OK.<br />
This facility will be based on the<br />
latest technologies and is designed to<br />
manufacture Umicore’s entire portfolio<br />
of precious metal-based catalysts and<br />
chemicals including advanced products,<br />
such as ruthenium metathesis catalysts<br />
and palladium cross-coupling catalysts.<br />
“The ability to operate on a global<br />
basis is one of our primary drivers.<br />
Building the Tulsa production facility<br />
will allow PMC to supply our customers<br />
in North America with today’s most<br />
advanced organometallic catalysts<br />
and chemicals conveniently and costeffectively,”<br />
said Matthias Grehl, VP,<br />
Precious Metals Chemistry.<br />
Production is scheduled to begin in<br />
the fourth quarter of 2013 and will be<br />
fully operational in early 2014.<br />
When completed, the facility<br />
will include a range of reactor sizes<br />
allowing PMC to provide customers<br />
with uninterrupted supply of catalysts<br />
from early development through<br />
commercial-scale production. It will<br />
be constructed using flexible-design<br />
infrastructure and equipment so that<br />
both current and future organometallic<br />
catalysts developed by Umicore’s R&D<br />
group can be readily produced. The<br />
facility also has additional square<br />
footage designated for a second-phase<br />
plant expansion and sits on a 53-acre<br />
campus with significant room for added<br />
manufacturing capacity.<br />
Umicore PMC’s current operation in<br />
South Plainfield, NJ, will be phased-out<br />
and activities will be integrated into the<br />
new facility.<br />
Visit Umicore at Booth 1131.<br />
Cambrex<br />
Inks Facility<br />
Expansion<br />
Cambrex has entered into an<br />
agreement to supply an active<br />
pharmaceutical ingredient for a<br />
customer’s Phase 3 program during<br />
2013 and 2014. Under this nonexclusive<br />
supply arrangement, Cambrex<br />
will manufacture and deliver Phase<br />
3 and pre-launch quantities of this<br />
product candidate.<br />
Cambrex currently is expanding its<br />
Charles City, IA, facility to increase its<br />
multi-purpose cGMP production capabilities<br />
related to this opportunity. The<br />
expansion started in August 2012 with<br />
anticipated completion in late February.<br />
Cambrex is a life sciences company<br />
that provides products, services<br />
and technologies to accelerate the<br />
development and commercialization of<br />
small molecule therapeutics.<br />
Visit Cambrex at Booth 1539.<br />
From Almac page 9<br />
distributed. All of these services are<br />
provided from a single Almac site with<br />
integrated technical teams managing<br />
the process from earliest development<br />
through launch.<br />
Almac provides a comprehensive range<br />
of services extending from research<br />
through pharmaceutical and clinical<br />
development to commercialisation of<br />
product.
16 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
J-Star Expands<br />
Its Research<br />
Horizons<br />
J-STAR Research, a contract research and small scale manufacturing<br />
CRO based in South Plainfield, NJ, has significantly strengthened its<br />
capabilities in the areas of cGMP manufacturing, analytical support,<br />
quality assurance, and chemistry personnel over the past year as a way to<br />
continuously provide clients a “Center of Excellence” in the field of small<br />
molecule process research and cGMP manufacturing.<br />
Areas that have been expanded include hiring of additional analytical<br />
chemists to support analytical method development and method<br />
qualification/validation supporting cGMP manufacturing, and bringing<br />
additional key quality assurance personnel with decades of industrial<br />
experience to assist in ensuring high quality assurance standards.<br />
The company has also brought on board chemistry personnel from<br />
some of the leading process research groups at major pharmaceutical<br />
companies in the New Jersey area. In addition, the company has acquired<br />
extensive equipment to broaden the technical capabilities of the company<br />
including an RC1 and a 20L high pressure hydrogenator. Visit J-STAR at<br />
Booth 1523.<br />
Oakwood Responds<br />
to Clients’ Needs<br />
Oakwood <strong>Chemical</strong> is a supplier of chemicals for research and development<br />
for more than 20 years. Its new facility on a 42-acre campus in Estill, SC.<br />
houses a seasoned staff of manufacturing chemists. Oakwood responds<br />
rapidly to the client’s needs for synthesis of non-GMP intermediates, from<br />
grams to multiple kilos. Since Oakwood maintains an inventory of reagents,<br />
solvents and intermediates, time and costs of projects can be reduced.<br />
Oakwood’s laboratories handle difficult materials and reactions. The<br />
high-pressure area routinely uses Sulfur Tetrafluoride and Hydrogen Fluoride<br />
to Fluorinate and catalyzed Hydrogen for reductions. The labs can utilize<br />
high hazard materials, such as Hydrogen Sulfide, Thionyl Chloride, N-Butyl<br />
Lithium, Chlorine, Bromine, Phosphorous Oxychloride and others.<br />
Whether clients are looking for a blocking reagent, such as Boc<br />
Anhydride, or a transportation sensitive compound, such as Trichloroacetyl<br />
Chloride, Oakwood carries an inventory in the U.S., as well at Hadfield,<br />
U.K. The company’s products are backed by its own in-house Quality<br />
Control department, using GC, GC-Mass, Chiral analysis, LC, NMR, and wet<br />
methods. Oakwood <strong>Chemical</strong> understands its clients’ needs as it is owned<br />
and managed by chemists.<br />
Visit Oakwood <strong>Chemical</strong> at Booth 1109.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 17<br />
Five Minutes With…<br />
Edward S. Price<br />
President<br />
PCI Synthesis<br />
What are your major concerns<br />
within your market over the next<br />
two years<br />
I’ve got two concerns about trends<br />
affecting the industry. The first is whether<br />
funding for small, emerging companies will<br />
continue. For a while small biotechs got<br />
funding from both the public markets and<br />
venture capital. When the funding from the public markets dried up, the small<br />
biotechs revamped their business model, became more virtual and developed<br />
a greater dependence on VCs for funding. The greater shift to reliance on VC<br />
funding has had a significant impact on the size, scope and approach that emerging<br />
biotechs now take to develop their products. We’re also seeing that VC funding is<br />
slowing as well. So where does that leave small biotechs Right now the primary<br />
exit strategy for VC-backed biotechs is to get acquired by big pharma.<br />
The problem, and my second concern, is that big pharma continues to<br />
consolidate. Pfizer and Wyeth merged; Merck and Schering-Plough merged;<br />
AstraZeneca bought Ardea Biosciences and Bristol-Myers Squibb and AstraZeneca<br />
jointly bought Amylin Pharmaceuticals.<br />
Today most VC-based biotechs’ exit strategy is to be acquired by big pharma<br />
player. With big pharma focused on merging with former competitors, there<br />
are fewer and fewer big pharma firms remaining. This thus limits the number of<br />
potential acquirers that will drive down prices, and, in turn, could drive down<br />
funding. The net result: loss of creativity and dwindling access to funding which will<br />
make value creation even more challenging.<br />
Among the challenges facing the industry, which one do you think<br />
is the most pressing—and why<br />
I think big pharma consolidation is the most pressing challenge facing the<br />
industry. The question is: Will there be enough opportunities for promising biotechs<br />
to sell their technologies Fewer big pharma companies mean fewer companies<br />
looking to acquire small companies. Aside from the business implications, this<br />
means that we may be missing out on the kinds of research that small biotechs can<br />
undertake—research that could lead to breakthroughs but that, at the outset, look<br />
unlikely to generate the kind of blockbuster returns that drive big pharma.<br />
What innovation (not your own company’s) do you believe has<br />
addressed a problem with a creative solution<br />
There is a great deal of work going on with continuous manufacturing. It is very<br />
innovative and inspiring because it seeks to dramatically change pharmaceutical<br />
manufacturing for both drug substance and drug product and has the potential<br />
to greatly improve efficiencies. But at the end of the day, a significant part of the<br />
challenge with continuous manufacturing won’t be the technological issues but<br />
regulatory issues such as how the process will be managed and how to deal with<br />
See 5 Minutes With…PCI Synthesis page 19
18 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
DFI Pharma to Represent CU in North America Region<br />
CU Chemie<br />
Uetikon, a<br />
custom research<br />
and manufacturer<br />
of Active<br />
Pharmaceutical<br />
Ingredients (NCEs<br />
and Generic<br />
Drugs), has<br />
appointed DFI<br />
Pharma, as<br />
representative of<br />
Chemie Uetikon’s<br />
business in North America. The change became effective last summer.<br />
DFI Pharma will represent CU for specialty fine chemicals, pharmaceutical<br />
intermediates, contract research—custom synthesis with supporting development;<br />
and custom manufacturing of new chemical entities.<br />
For more than 14 years, Faghani served Chemie Uetikon as a director of North<br />
America region. He will now continue his co-operation with CU as an independent<br />
representative and authorized distributor in the same region.<br />
Registered in April 2012, David Faghani Inc. is a legal entity, a New Jersey corporation<br />
with a principal place of business at 65 Richmond Drive, Skillman, NJ 08558.<br />
CU’s new representative office is a milestone in the company’s strategy to affirm<br />
its commitment to fine chemicals and pharmaceutical markets and to provide better<br />
service and support to all CU’s customers, agents and distributors.<br />
DFI Pharma will offer customers options to choose how they wish to be served.<br />
The main focus will be to provide direct commercial support to CU’s customers<br />
in collaboration with CU’s agents and distributors and to develop new business<br />
opportunities in the America market.<br />
DFI Pharma offers many services to exclusive principal<br />
David Faghani Incorporated (DFI Pharma), a privately held multi-national sourcing and<br />
supplier of pharmaceutical ingredients, specializes in sales, marketing, distribution, and<br />
commercial development (market segments & research analysis) for high quality products<br />
and services offered by its exclusive principal.<br />
Their products and services include: specialty fine chemicals; GMP<br />
pharmaceutical intermediates; advanced intermediates; contract research—<br />
custom synthesis with supporting development, analytics, quality and regulatory<br />
documentations; APIs (NCEs) manufactured under full cGMP—contract<br />
development and manufacturing of new chemical entities and niche generic<br />
representing an increasing part of our business; new developmental of generic APIs<br />
manufactured under full cGMP; and out-licensing of new generic APIs through a<br />
network of pharmaceutical drug manufacturers having a strong compliance system<br />
in place, as well as, meeting all regulatory requirements.<br />
With 30 years of experience serving the specialty chemical and pharmaceutical<br />
markets, from early stage development to commercial, DFI Pharma has gained<br />
an understanding of its sectors while creating strong and long-term business<br />
partnerships. Intellectual properties rights will remain a fundamental factor in the<br />
development of NCEs or new generic drugs.<br />
DFI Pharma actively promotes and defends the right of its clients and principal<br />
partners with regard to patent and regulatory issues.<br />
Visit Chemie Uetikon and DFI Pharma at Booth 1545.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 19<br />
From PCI Synthesis page 17<br />
it from a quality assurance and quality<br />
control perspective. As in other areas<br />
of technology—like driverless cars—the<br />
regulations will be lagging behind the<br />
technology.<br />
What should be the common<br />
goals within the industry and/<br />
or marketplace<br />
There are two areas at least where I<br />
see the industry should work together.<br />
The first is to help attract and train<br />
employees to the industry. We should<br />
all embrace as a common goal the<br />
need to get behind training people in<br />
the skills they need to be employed.<br />
We need more qualified technical folks<br />
to do the work that we all need to<br />
get done. This shortage of qualified<br />
employees is going to get worse over<br />
the next few years.<br />
The second area is dealing with<br />
regulations. Perhaps if, as an industry,<br />
we worked to raise standards, we could<br />
achieve the same goals without incurring<br />
the costs of meeting new regulations.<br />
On the one hand, we’re trying<br />
to drive down the cost of health care<br />
while we’re increasing the demands<br />
and costs of manufacturing. Those are<br />
incompatible goals. As an industry,<br />
we’re going to have to figure a way to<br />
balance out the demands and the costs.<br />
development. That’s going to be a<br />
significant issue impacting all of us.<br />
What are two strategies—either<br />
personal or professional—you<br />
feel important to initiate this<br />
yearCost-cutting Additional<br />
capital expenditure Additional<br />
marketing investments Team<br />
building More emphasis on<br />
social media<br />
Due to increasing regulations,<br />
we’re seeing that our projects are<br />
getting to be more complicated from<br />
a technical, GMP, and regulatory<br />
paperwork perspective. There’s more<br />
for us to manage. We’re going to have<br />
to develop more resources to manage<br />
projects, and the details of around<br />
those projects. So that’s going be to a<br />
strategic focus for us. The other focus<br />
is to prepare for a number of product<br />
launches that we’re expecting over the<br />
next 18 months. We’re working on<br />
getting the organization ready for when<br />
those products launch. Because of the<br />
increasing levels of new regulations and<br />
our own new product launches, we’re<br />
expecting to have to hire more people.<br />
We will need to boost the training of<br />
our current employees to be able to<br />
execute and meet the needs of our<br />
customers.<br />
PCI Synthesis is a pharmaceutical<br />
manufacturer of new chemical entities<br />
(NCEs), generic active pharmaceutical<br />
ingredients (APIs), and other specialty<br />
chemical products.<br />
What is one relevant question<br />
(and your answer) that you<br />
believe no one is addressing<br />
adequately<br />
Right now, aside from the funding<br />
issue, the big question is this: Where<br />
are the next generation of employees<br />
going to come from It’s harder today<br />
than ever to find qualified people.<br />
Three quarters of the prospective<br />
technical employees we see are<br />
foreign born. We see a lot of talented<br />
candidates from India and China. But<br />
because quality of life, including salaries<br />
and job opportunities, are improving<br />
in those countries, fewer candidates<br />
are seeking jobs in this country. The<br />
skills gap is only going to widen as<br />
similarly smart kids in the U.S. seem<br />
to prefer working for Google or Apple<br />
or an app company, which is seen as<br />
“cooler” than working in biotech or<br />
pharmaceutical manufacturing and
20 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
A t D e a d l i n e<br />
<strong>Chemical</strong>s Incorporated Posts Extensive Experience<br />
For more than 30 years, <strong>Chemical</strong>s Incorporated has provided<br />
the specialty chemicals industry with custom manufacturing<br />
and chemical intermediates at the lowest possible cost. With<br />
two Texas facilities—Baytown and Bay City—and rail capabilities,<br />
CI can manage supply chain requirements efficiently. CI’s<br />
extensive experience with a broad spectrum of chemical reactions,<br />
significant R & D lab expertise, pilot plant, and scale up<br />
capabilities can facilitate fast commercialization and market introduction of projects. CI is<br />
ISO 9000 registered and has advanced processing equipment and highly qualified staff<br />
to create value meeting your expectations. For details on chemicals toll manufacturing,<br />
private brand capabilities, or cost/performance advantage, contact: www.chemicalsinc.<br />
com/(281) 576 5000—Rich Miskowski, Chuck Castley, or Pal Arjunan. Visit <strong>Chemical</strong>s<br />
Incorporated at Booth 1957.<br />
Biazzi Features In-house Test Center<br />
Biazzi is a leading global provider of engineering, technologies, services, and hardware<br />
systems for the manufacture of explosives, for the nitration of aromatics, and for catalytic<br />
gas-liquid reactions. Scale-up and process and optimization for gas-liquid reactions are<br />
performed in its in-house test center and build the basis for the design of the industrial<br />
plant, with associated process guarantees. Industrial plants are provided with a size of up<br />
to 50m3 reactor volume. Pressure and temperature limits are 200bar and 300°C. Biazzi’s<br />
scope of supply ranges from the delivery of the basic engineering and the key-equipment<br />
up to the delivery of complete modular plants (SKIDs) for all areas of the chemical, pharmaceutical,<br />
plastic industry, and for parts of food industry. Visit Biazzi at Booth 1758.<br />
Pope Scientific Showcases Wide Range of Services<br />
Pope Scientific offers distillation toll processing services and equipment,<br />
including wiped film molecular (short-path), evaporation, and novel hybrid<br />
fractional column distillation technologies for heat sensitive materials with close<br />
boiling points. The company provides lab, pilot plant, and production scale<br />
capabilities. Toll services for kosher and GMP requirements are available. Pope<br />
Scientific has batch and continuous type turnkey fractional column distillation<br />
sytems and components in stainless steel and Hastelloy, as well as Nutsche<br />
filter-dryers, benchtop size, pilot, and production sizes. There are pressure<br />
vessels and turnkey process vessel systems, reactors, fermenters, mixing,<br />
blending, dispensing, and other processes, custom designed and built to suit the<br />
application, as well as pressurizable sanitary mixers. Visit Pope Scientific<br />
at Booth 1254.<br />
DrM On-going Filtration Systems Leader<br />
DrM, Dr. Müller AG, and its U.S. subsidiary DrM Inc. have been and continue<br />
to be one of the international leaders in providing filtration systems for solid/<br />
liquid separation in the processing industries for the last 30 years. DrM has more<br />
than 2800 of its main products—the FUNDABAC and CONTIBAC Filters—in<br />
operation worldwide and approximately 130 new systems are put in place every<br />
year. Applications and uses are widespread in various industries, such as chemicals,<br />
polymers, oil and gas, steel, pharmaceuticals, food and food additives, and<br />
electronics. DrM has added the FUNDAMIX to its family of products. It is a universal<br />
device for mixing liquids in open or closed vessels, under vacuum or pressure, even<br />
under sterile conditions. Visit DrM at Booth 1758.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 21<br />
Federal Equipment’s<br />
Experience Translates<br />
into Buying Power<br />
Federal Equipment offers an array of<br />
services, including the liquidation and<br />
auction of process lines and manufacturing<br />
facilities, equipment appraisals, among<br />
others. It provides extensive buying and<br />
selling experience, purchasing power, and<br />
global marketing reach, supplies API and<br />
specialty chemical machinery.<br />
Experience in various specialized<br />
markets enables it to provide clients with<br />
asset disposition solutions, regardless of<br />
the size, location, or complexity of the<br />
project. With its value-added strategies<br />
that advance clients’ investment recovery<br />
goals, its customized solutions maximize<br />
profitability.<br />
A strategic relationship with Pfizer<br />
provides Federal Equipment with stock<br />
that includes the used process and<br />
packaging equipment. Visit Federal<br />
Equipment at Booth 2030.<br />
Advertisers<br />
Index<br />
AMPAC Fine <strong>Chemical</strong>s, Booth 2257,<br />
www.ampacfinechemicals.com ...........2<br />
Ash Stevens, Inc., Booth 1552,<br />
www.ashstevens.com .............. Cover<br />
BioVectra Inc., Booth 2156,<br />
www.biovectra.com ....................8<br />
Cambridge Major Laboratories, Inc.,<br />
Booth 2225, www.c-mlabs.com ..........19<br />
C&EN, Booth 2447, cen.acs.org .......17, 18, 20<br />
Chemtura Corp., Booth1548,<br />
www.chemtura.com ...................8<br />
DFI Pharma, Booth 1545,<br />
www.dfipharma.com ...................9<br />
Evonik, Booth 1238,<br />
www.evonik.com/pharma ..............24<br />
Fabbrica Italiana Sintetici SpA,<br />
Booth 2049, fisvi.com .................11<br />
Federal Equipment Co., Booth 2030, www.<br />
fedequip.com .......................17<br />
Helsinn Advanced Synthesis S.A., Booth 1809,<br />
www.helsinn.com ....................10<br />
J-Star, Booth 1343,<br />
www.jstar-research.com ...............14<br />
LIST USA Inc., Booth 2419, www.list.us .......21<br />
Nova Molecular Technologies, Inc.,<br />
Booth 1442, www.novamolecular.com ......9<br />
Oakwood Products, Inc., Booth 1109,<br />
www.oakwoodchemical.com ............23<br />
Organic Technologies, Booth 1247,<br />
www.organictech.com .................14<br />
PCI Synthesis.com, Booth 1059,<br />
www.pcisynthesis.com .................16<br />
PharmaCore, Inc., Booth 1303,<br />
www.pharmacore.com ................15<br />
Ricerca Biosciences, Booth 2060,<br />
www.ricerca.com .....................21<br />
Siegfried USA, Inc., Booth 1101,<br />
www.siegfried.ch .....................16<br />
Umicore AG & Co. KG, Booth 1131,<br />
www.umicore.com ....................7<br />
Zach Stystem S.P.A., Booth1701,<br />
www.zachsystem.com .................18
22 INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California<br />
History is in the making at C&EN this year, as the publication celebrates its<br />
90th anniversary with a variety of landmark initiatives, including a special<br />
Sept. 9 issue profiling significant chemistry milestones. Additionally, its vast<br />
archives are spotlighted online each week, where a pictorial blog features<br />
provoking chemistry-related contests.
INFORMEX Show Daily | <strong>Thursday</strong> February 21 2013 | Anaheim Convention Center Anaheim California 23<br />
In a session Wednesday, Lalit Baregama, CEO and president of Syngeny, briefed the audience<br />
about the latest applications of specialty chemicals to drive technical innovation.<br />
From API Sourcing page 1<br />
tion technology skills for data and customer management, and political stability.<br />
Due to regulatory challenges and escalating costs, Speace suggested that<br />
companies wanting to do business with India consider the environmental, health,<br />
and safety records of suppliers there. Additionally, they should find out whether<br />
the drug is licensed by the Indian government, whether the company has ISO<br />
certifications and regulatory inspections. “When asking how committed your<br />
supplier is, you should determine operating and regulatory history, investments in<br />
facilities and talent, presence in your market, and customer support programs in<br />
place,” he said.<br />
From Green Chemistry page 1<br />
In the pharmaceutical supply chain, outsourcing is driven by cost, flexibility<br />
requirements, and increasing capabilities of contract manufacturing organizations.<br />
Companies must design sustainability into products and processes from inception<br />
and have early, frequent assessment, Constable said, adding “Finding the right<br />
balance is challenging.”<br />
Green chemistry spurs innovation when companies think about improving the<br />
environment while obtaining equal or better performance from green processes and<br />
remaining economically viable. The principles of green chemistry are maximizing<br />
resource efficiency, eliminating or minimizing hazards, designing systems holistically,<br />
and using life cycle thinking, according to Constable.<br />
Last year’s National Science Foundation’s Sustainable Chemistry Workshop concluded<br />
that systems level thinking is required, more fundamental research should be<br />
use-inspired, and green is not synonymous with sustainable. Furthermore, efficiency<br />
is necessary but not sufficient, and sustainability research and education should be<br />
multi-disciplinary and collaborative. “We have to develop a different set of skills,”<br />
Constable said, adding that the process can be streamlined by finding the right metrics<br />
“that are simple, meaningful, essential, and based on systems already in place.”<br />
The business of green chemistry has to emphasize how new or replacement markets<br />
will affect revenues, how greater efficiency and automation will reduce costs, how<br />
business and government processes will impact risks, how intangibles will affect the<br />
company’s image, and how new strategies will affect value and quality.<br />
ACS roundtables are showing companies how to collaborate non-competitively,<br />
address technical challenges, develop decision-making tools, and add resources to<br />
the supply chain.<br />
“<strong>Chemical</strong> companies have to understand that the risks are real, early<br />
design makes green chemistry workable, and resources are available,”<br />
Constable concluded.<br />
Thomas Speace, president and CEO of Neuland Laboratories<br />
India’s high degree of government control lends itself to bureaucracy and<br />
corruption, Speace said. “Patience is more than a virtue,” he added. “Invest the<br />
time to build relationships.”<br />
China is even bigger and more diversified, with unique cultures and languages<br />
in different provinces, according to Hui-Yin (Harry) Li, president of Wilmington<br />
PharmaTech Co. Most API production takes place along the Pacific coast where<br />
water for manufacturing is vital.<br />
Li cautioned that sometimes doing business depends on how <strong>American</strong> companies<br />
can support the capabilities of API suppliers in China to overcome deficiencies.<br />
“You need to know the boss and how he operates the place,” he said. “You have<br />
to understand the company’s relationship with the local government, the suppliers’<br />
resources, and whether they can invest in facilities and sustain growth.”<br />
API producers in China evolved from small town-owned chemical shops, cityowned<br />
local pharmaceutical companies, trading companies, new ventures managed<br />
by “returnees,” shops run by academics, and a combination. Some companies fail<br />
quickly, so companies doing business with them have to be vigilant regarding recent<br />
performance, current assets and capabilities, as well as the backgrounds of the<br />
people and organizations running them.