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4 INFORMEX Show Daily | Thursday February 21 2013 | Anaheim Convention Center Anaheim California
Part 2: Showcases Highlight Company Strengths, Growth
Editor’s Note: This roundup of InformexUSA Showcases is a Part 2 followup to
Tuesday’s presentations aimed at briefing attendees on companies’ most recent
developments within the industry. More showcase coverage will appear in the
InformexUSA Show Daily wrap edition.
Catalent is into heavy metal
Michelle Cree, a senior scientist at Catalent
Pharma Solutions, discussed new regulatory
expectations and solutions related to toxic
metals in the harmaceutical supply chain.
She related that pharmaceutical testing
for elemental impurities in excipients,
API (active pharmaceutical ingredient)
and drug products is necessary to ensure
product quality and consumer safety. USP
General Chapter 231 has been used since
1905 to assess “heavy metal” content in
pharmaceutical products.
Michelle Cree,
The talk discussed the reasons for
senior scientist, Catalent
replacing General Chapter 231 and outlined
the new requirements for USP Elemental Impurities testing as described in General
Chapters 232 and 233. Cree described strategies for compliance with these new
requirements and provided development and validation examples from case studies
performed in Catalent’s laboratories.
Headquartered in Somerset, NJ, the company serves thousands of innovators,
large and small, in more than 100 markets, including 36 of the top 50 biotech
companies and 49 of the top 50 pharmaceutical companies. Catalent employs
9,000 people and its team of more than 1,000 scientists supports 40 percent of
recent new drug approvals.
Chiral Quest announces future direction
Chiral Quest announced its new CEO
James Wu and its merger with Jiang Xi
Long Life Biopharmaceuticals, a commercial
manufacturing plant near Nanchang, in
Jiangxi Province, China.
Chiral Quest is a U.S.-based company
founded in 2000 and Jiangxi Long Life
was founded in 2009. While Chiral Quest
Suzhou is focused on R&D and pilot plant
operations, Chiral Quest Long Life is focused
on commercial scale manufacture. The
combined company has more than 100,000
L of manufacturing capacity, with expertise
Ian Lennon, senior VP, Chiral Quest
in high pressure asymmetric hydrogenation
and cryogenic reactions. The company has successfully developed and scaled
up many processes for the commercial manufacture of both chiral and achiral
intermediates.
Cambrex makes potent statement
Cambrex’s showcase highlighted its custom development and manufacturing
capabilities, including analytical development, process validation, and finished
dosage form manufacture.
John Michnick, associate director of sales and business development, said the
company’s high potency development center provides containment and rigorous controls
to reliably and safely develop and manufacture a wide range of high- and ultra-high
potency APIs and intermediates, including
oncologics and controlled substances.
Globally, Cambrex offers a variety of
technology-driven products and services
that accelerate the development of small
molecule therapeutics from custom
development to commercial manufacturing,
including high potency APIs and drug
intermediates. The company manufactures
more than 120 generic and branded
APIs, as well as advanced pharmaceutical
intermediates. The company’s commitment
John Michnick,
to quality, safety and regulatory compliance
associate director, Cambrex
allows Cambrex to seamlessly support its
clients’ API needs from clinical trials through commercial launch.
Founded in 1981 as CasChem, the company was renamed Cambrex in 1987.
Cambrex entered the pharmaceutical market in 1994 with the acquisition of
Nobel Pharma Chemistry. Through multiple acquisitions during the late 1990s, the
company entered the bioscience and chiral enzymatic catalyst markets.
Senn discusses practical peptide considerations
Senn Chemicals highlighted the synthetic
challenges of peptide-based therapeutics
at its showcase. According to Richard
Pariza, peptide-based therapeutics, as well
as peptidiomimetic drugs, present unique
challenges to synthetic chemists. New
reagents and techniques, as well as the
expertise of experienced peptide chemists,
are essential to the research-scale as well as
the manufacturing of these important new
drugs. The session focused on the practical
considerations that can ensure efficiency
and success in biotech/pharma peptide
Richard Pariza, Senn Chemicals
manufacturing.
Senn Chemicals was founded in 1963 and has been specializing in customized,
cost-effective solutions to a variety of compound, process and manufacturing
challenges. Senn’s cGMP manufacturing facilities, based outside of Zurich,
Switzerland, support its primary development, production and analytical capabilities.
The company currently has offices in Menlo Park and San Diego, California.
Senn Chemicals has been providing custom manufacturing services to
pharmaceutical, biotechnology, diagnostic and cosmeceutical companies worldwide.
With specific emphasis on peptides and complex organic molecules, Senn possesses
deep expertise of both development and production.
APC adds value to peptide production
American Peptide Company is dedicated to serving the life science community by
providing tools for peptide research. At its showcase presentation APC described
how it offers comprehensive selections of pre-manufactured catalog peptides,
custom synthesis, and GMP peptide active pharmaceutical ingredients.
The company’s California-based manufacturing facilities offer synthesis services
under non GMP (Sunnyvale) and cGMP (Vista) conditions. American Peptide’s cGMP
manufacturing is performed under strict adherence to FDA Regulations 21 CFR parts
210, 211 and ICH Guidance Q7A. Its total peptide management services support
clients in the drug development process from pre-clinical through commercial stage.
Value added services include process development, scale up production, analytical/