Flexible Facilities

IBC Life Sciences Presents State-of-the-Art… 

Flexible Facilities 

7 Case Studies 

Illustrate How 

to Enhance Your 

Production 

Strategies 

Innovative Biopharmaceutical Manufacturing Solutions for Multi-Product Pipelines, 

Global Markets, On-Demand Scale-Up/Scale-Down and Capacity Optimization 

FLEXIBLE BIOPROCESS 

FACILITIES 

BPOG BEST PRACTICES 

BIOPHARMA 

PRODUCT TRENDS 

INTEGRATED CONTINUOUS 

BIOPROCESSING 

FLEXIBLE & EFFICIENT 

GLOBAL MANUFACTURING 

James P. Miller, 

Vice President and Head, 

Biologics Drug Substance 

Manufacturing, 

Genentech, Inc. 

Joerg Heidrich, 

Senior Vice President, Global Head, 

Product Supply-Biotech, Berkeley 

Site Head, Bayer HealthCare 

Pharmaceuticals 

Johannes Roebers, Ph.D., 

Executive Vice President, 

Head of Operations, 

Elan Pharma International 

Limited, Ireland 

Konstantin Konstantinov, Ph.D., 

Vice President, Technology 

Development, Genzyme, 

a Sanofi company 

Jens Vogel, Ph.D., 

Executive Director, Process 

Science & Technology Officer, 

Boehringer Ingelheim 

Fremont, Inc. 

Collaborate and Prepare for the Rapidly Changing Landscape 

of Biomanufacturing Facility Needs 

Rapid Deployment/ 

Globalization 

M+W Group 

Pfizer 

BARDA 

Novel Facility Designs 

Biologics Modular 

GE Healthcare 

Bayer Healthcare 

Single-Use 

Implementations 

Janssen 

Sanofi Pasteur 

CMC Biologics 

Facility Case Studies 

Biogen Idec 

NNE Pharmaplan 

Lonza 

and more…. 

Global Coverage - Speaker 

Faculty from 7 Countries 

April 2-4, 2013 • The W Hotel • San Francisco, CA 

www.IBCLifeSciences.com/Facilities 

Premier Publication: Principal Sponsors: Associate Sponsors: Corporate Sponsors: 

Event Partner:

A New Paradigm of Flexible Bioproduction to Meet Diverse 

PREPARE Your Facility or CMO to Meet the Needs of a 

Changing Biomanufacturing Landscape 

n Diverse product portfolios, lower volumes and personalized medicines 

n Global product deployment in BRIC regions and other emerging markets 

n Multi-product facilities with low cross-contamination risk 

n Flexible production for changing market conditions and product demand 

DISCOVER Exciting New Concepts 

in Facility Design and Deployment 

n Rapid scale-up/down, modular and plug & play designs 

n Multi-product concepts, open ballrooms and closed systems 

n 100% disposable, hybrid and retrofitting stainless steel facilities 

LEARN Practical Lessons, Advantages and Limitations 

of Disposables in Biomanufacturing 

n The do’s and don’ts of facility design using single-use technologies 

n Getting the most out disposables and understanding the range of use 

n Understanding E&L, quality considerations and vendor supply realities 

n Case studies of 100% disposable or hybrid facilities and experiences to date 

EVALUATE the Technical, Regulatory and Economic 

Considerations of Flexible Facilities 

n Technologies available/required to deliver on facilities and processes of the future 

n The economics of stainless vs. disposables and other flexible designs 

n Regulatory and quality impact and risk of facility of the future concepts 

Register Today for a Look at State-of-the-Art Facilities, Technologies and 

Processes to Optimize Your Future Production Needs 

2 Register Early for Best Savings • www.IBCLifeSciences.com/Facilities • 800-390-4078

Market Needs, Products and Geographies Is Rapidly Emerging 

Tuesday, April 2, 2013 

7:00 Registration and Coffee 

8:00 Chairman’s Remarks 

Thomas Seewoester, Ph.D., Executive Director, Clinical Drug Substance 

Manufacturing, Amgen, Inc. 

Changing Industry Dynamics That Are Driving the 

Need for Flexible Facilities 

8:05 Impact of Integrated Continuous Bioprocessing on the 

Design of the Manufacturing Facility of the Future 

Abstract not available at time of print. Please visit 

www.IBCLifeSciences.com/Facilities for updates. 

Konstantin Konstantinov, Ph.D., Vice President, Late Stage Process 

Development, Genzyme, a Sanofi company 

8:40 Current and Future Trends in Biopharmaceuticals: 

Biosimilars, Biosuperiors and Novel Biopharmaceuticals 

This presentation discusses past and current sales of biopharmaceuticals, 

biosimilars and biobetters. The current product trend will then be expanded 

by looking into the future and the pipeline of biosimilars, biosuperiors 

and novel biopharmaceuticals. Specific product and therapeutic examples 

will be given. The current and future product trend will then be analyzed 

and predictions about the demands of biopharmaceutical development, 

operations and facilities will be made. 

Johannes Roebers, Ph.D., Executive Vice President, Head of Operations, 

Elan Pharma International Limited, Ireland 

9:15 Trends in Biomanufacturing Facility Design and Operation – 

Integrating the People, Technical, Regulatory and Procedural 

Elements to Provide Flexible, Cost-Effective and High 

Quality Capability 

Bioprocessing of bulk drug substance biologics has changed and developed 

significantly over the past decade. Industry capacity comprising large 

scale facilities are being supplemented with a new generation of smaller 

scale, highly flexible multi-product plants. This evolution is challenging 

but technical and procedural innovations are enabling them to be met 

economically whilst potentially improving product quality and patient safety. 

This presentation describes how diverse concepts and technologies are 

coming together and how new skills and capabilities are critical to success. 

Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom 

9:45 Panel Discussion: What Defines a Flexible Facility 

• Does it mean easier facility validation and fewer regulatory hurdles 

• Does it mean quick facility deployment and production ramp up 

• Does it mean disposables Or modular Or open ballroom 

• Does it mean multi-product facilities Or easier scale-up capability 

• What does “flexible” mean for stainless steel production facilities 

Moderator: 

Thomas Seewoester, Ph.D., Executive Director, Clinical Drug Substance 

Manufacturing, Amgen, Inc. 

10:15 Networking Refreshment Break with Exhibit and Poster Viewing 

Hosted by: 

New Concepts in Flexible Biomanufacturing Facility Design 

10:45 Continuous Processing in Biotech Production as an 

Alternative to a Modern Batch, Single-Use Facility 

Drug, and in particular, process development during clinical phases is 

required to be fast and flexible. As a result, the current operation mode 

in biotech processing is batch. The addition of single use, skid-mounted 

and closed systems in a ballroom type concept are introduced, keeping in 

mind flexibility and time to market. Is biotech continuous processing an 

option What are the potential advantages of a fully single-use continuous 

process and can this be an alternative to the modern, smaller scale batch 

operation This presentation discusses these questions and anticipates the 

opportunities and challenges. 

Thomas Daszkowski, Ph.D., Vice President, Process Technology, 

Bayer Healthcare, Germany 

11:15 CASE STUDY Flexible Facilities – What Does it Mean from a 

Design Perspective 

Today’s challenge is to create flexible biopharmaceutical operations to meet 

internal research, clinical and market-entry requirements while minimizing 

cost and maximizing speed, flexibility and efficiency. DSM has designed 

a blueprint for commercial manufacturing facilities to produce 500kg of 

biopharmaceuticals annually on a footprint as low as 87.000 ft². This case 

study discusses some of these facility design implications: 

• Open plan approach to clean room design; mobile equipment 

• Flexibility in handling a variety of cell culture processes and bioreactor sizes 

• 100% Single-Use upstream equipment 

• Minimal cleaning/sterilization validation needed 

• HVAC units design to prevent cross-contamination of the air 

• Increased process effectiveness while minimizing environmental impact 

• Less water and energy consumption 

• Lower waste production 

Francis B. Maddalo, Vice President Operations/Facility Development, 

DSM Biologics 

11:45 Accelerate Local Production: Quality and Speed with Cost 

Control for the Biopharmaceuticals of the Future 

The development of modular biomanufacturing facilities presents an 

opportunity to meet local healthcare challenges of the future. Scalable 

production of multiple biotherapeutics using single-use technology 

platforms reduces capital costs and drives process efficiencies while 

increasing operational flexibility and production capacity. Pre-fabricated 

units and shorter assembly times improve planning and enable potentially 

life-saving treatments to be delivered where they are needed more quickly. 

Daniella Kranjac, Business Development Manager North America, 

GE Healthcare Life Sciences 

12:15 Networking Luncheon with Exhibit and Poster Viewing 

Hosted by: 


Kenneth Green, Ph.D., Director, Technical Services, Pfizer, Inc. 

Rapid Deployment and Global Market Localization 

1:30 Portable Manufacturing Solutions for Market Localization 

With the advent of single-use technologies, the opportunity to couple process 

steps within closed systems is feasible. Furthermore modularization of 

manufacturing platforms could enable rapid start-up and flexibility for localized 

manufacturing operations with replication in other markets. This presentation 

discusses current experiences in market localization and associated challenges. 

Kenneth Green, Ph.D., Director, Technical Services, Pfizer, Inc. 

2:00 Panel Discussion: A Comparison of 

Sponsored by: 

Real World Flexible Facility Approaches 

Based on M+W Group experience in the delivery of 

Flexible Facilities around the world, a comparison of 

executed projects illustrates the pros and cons as well 

as the commonalities of the various approaches (stand-alone modules, 

component construction and conventional construction) to Flexible Facilities 

for biomanufacturing that are being applied in the marketplace. The analysis 

is made, using three recently delivered projects, by the project executives that 

led the project teams. The panel discusses: 

• How fast is fast Is the rapid development of GMP process suites and 

facilities (9 to 12 months to engineering lots) really possible 

• How flexible are these “standard” approaches 

• What are the real economics of the various approaches 

• What are the limits to the various approaches 

• What are the regulatory and quality hurdles that need to be addressed 

Panelists: 

Peter Cramer, Vice President - Life Sciences Facility Design, M+W Group 

H. Steven Kennedy, Director, Life Sciences + Chemicals, M+W Group 

William Jacobsen, BioProcess Specialist, M+W Group 

George Wiker, Principal, LifeTek 

For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/Facilities 3

Tuesday, April 2, 2013 (continued) 

Flexible Bioproduction Strategies for Vaccines, 

Pandemics and Biothreats 

2:30 CASE STUDY Increasing Flexibility in Vaccine 

Manufacturing Processes and Facilities with 

Disposable/Single-Use Technologies 

This presentation discusses specific examples of the use of single-use 

disposable technologies in the downstream purification and the formulation 

and filling of our vaccine clinical products. In addition to increasing the 

speed of process development, single-use disposable technologies are less 

technically complex, have lower investment costs and offer a wide variety of 

flexibility and ease in facility change-over. 

Tony D’Amore, Ph.D., Vice President, Bioprocess Research & Development, 

North America, Sanofi Pasteur, Canada 


Hosted by: 

3:30 CASE STUDY Case Study of a Flexible, Multi-Product Vaccine 

Facility: Medigen, Taiwan 

Medigen is a company that is planning to produce a number of different 

vaccine products in a new green field facility in Taipei, Taiwan. This case 

study discusses: Level of flexibility required for two production lines; 

Changeover from BSL2 to non-BSL functions of various process areas; 

Uni-directional flow as a tool for process segregation; Modular versus nonmodular 

facility design; Manufacturing logistic challenges by operation in a 

multi-product facility. The presentation is based on the basic design study 

that will finalized in March, 2013. 

Niels Guldager, Senior Technology Partner, NNE Pharmaplan, Denmark 

Klaus Hermansen, Senior Technology Partner, NNE Pharmaplan, Denmark 

4:10 Flexible and Nimble Manufacturing in the Centers for 

Innovation in Advanced Development and Manufacturing 

In June 2012, HHS/BARDA established three new Centers for Innovation in 

Advanced Development and Manufacturing to assist developers of biodefense 

medical countermeasures to produce vaccines and biological products in the 

event of an influenza pandemic or an emerging disease outbreak. The Centers are 

public-private partnerships that utilize novel flexible and nimble manufacturing 

approaches coupled to modern cell-, recombinant-, and molecular-based vaccine 

and biological product technologies. The Centers train scientists and technicians 

who will operate these facilities and meet the national need for more highlyskilled 

personnel for the biotech and pharmaceutical industries. 

Robin Robinson, Ph.D., Director, Biomedical Advanced Research 

and Development Authority (BARDA); Deputy Assistant Secretary for 

Preparedness & Response, U.S. Department of Health and Human Services 

4:40 Panel Discussion: Deploy Ready Facilities 

Sponsored by: 

• Cost effective, pre-engineered facility structures 

• Rapid deployment capabilities to create manufacturing process flexibility 

• Replication – how to replicate multi-site manufacturing strategies 

• Transportability of facilities for global deployment 

Panelists: 

Clark Byrum, President and CEO, Biologics Modular 

Peter Bell, Scientist, EMD Millipore 

5:10 Networking Wine and Cheese Reception 

with Exhibit and Poster Viewing 

6:10 Close of Day One 

7:30 Coffee 

7:45 Morning Presentation Sponsorship Opportunity 

For more information, please contact Sherry Johnson at sjohnson@ibcusa.com 


Konstantin Konstantinov, Ph.D., Vice President, Late Stage Process 

Development, Genzyme, a Sanofi company 

Flexible Facilities for Flexible Production Needs 

8:20 Flexible Bioprocess Facilities of the Future 

Instead of a one-size-fits-all approach to biomanufacturing, the Roche/ 

Genentech vision for facilities of the future encompasses several different 

types of factories to fit a diverse product portfolio and a global market. This 

presentation discusses a number of different facility concepts that Roche/ 

Genentech deployed throughout the world including traditional stainless 

steel, hybrid, modular, etc. Perspectives and learnings gained in various 

facilities to enhance flexibility in both clinical and commercial manufacturing 

will be presented. 

James P. Miller, Vice President and Head, Global Biologics Drug Substance 

Manufacturing, Genentech/Roche 

9:00 Flexible & Efficient Global Manufacturing Platforms for 

Clinical Supply & Launch 

While the pipelines of the biopharmaceutical industry are dominated by 

monoclonals today, therapeutic proteins, fusion proteins, bi-specifics, 

ADCs and other formats present enormous therapeutic and economic 

potential. Therefore, flexible platforms and facilities are needed to manage 

a wide range of material demand and variability in unit operations. This 

presentation discusses BI’s approach, including the establishment of our 

global disposables platform, which allows us to efficiently meet the demands 

of global clinical trials and markets. 

Jens H. Vogel, Ph.D., Executive Director, Process Science and Technology 

Officer, Boehringer Ingelheim Fremont, Inc. 


Hosted by: 

Wednesday, April 3, 2013 

Implementing Disposable Single-Use Technologies to 

Create More Flexible Production Facilities 

Sponsored by: 

10:00 Grams to Kilograms: Flexible Factories Made a Reality - 

Going from PD-Clinical-Commercial 

Leveraging extensive site experience with tech transfers and commercial 

launches facilitated Gallus' complete integration to include PD and 

Clinical Production capabilities. By leveraging commercial experience with 

disposables, and single-use platform technologies, Gallus has established 

pathways from development, through commercial production, including 

the concept of client-dedicated commercial suites (SuiteSPACET) This 

presentation addresses how selection of facility layout, single-use and hybrid 

equipment can improve utilization of assets in variable run quantity projects. 

This approach enables the client to reduce their capital commitments and 

program implementation costs, while accelerating schedule to market. 

David Fritsch, Director of Engineering, Gallus BioPharmaceuticals 

10:30 Flexibility in Biopharmaceutical Manufacturing Facility Design 

CMC Biologics, a leading global cGMP CMO, seeks to improve its commercial 

and clinical manufacturing operations, quality systems, responsiveness, flexibility, 

and cost structure. CMC Biologics has successfully implemented single-use 

technologies (SUT) in numerous ways across two manufacturing sites in the EU 

and US in the last few years, including single-use bioreactors from 50 to 2000 

liters in capacity, single-use mixers from 50 to 1000 liters in capacity, and bin/bag 

liquid storage systems of varying sizes. This presentation reports lessons learned 

and benefits derived from the implementation of these technology platforms, 

with special emphasis given to the utilization of single-use bioreactors. 

Andy W. Walker, Ph.D., Vice President, Process Development, CMC Biologics 

Take an Active Role in the Conference and Present a Poster 

Any registered conference attendee may register to present a poster. The deadline to submit an 

abstract online is March 1, 2013 to have the abstract be included in the conference materials. Full 

payment of conference registration and poster fees must be received by this date for the abstract to be 

included in the conference materials and a poster board assignment to be made (see the registration 

page for details on the poster fee). Posters should be PORTRAIT orientation, with maximum 

dimensions of 36 inches wide (3 feet) x 48 inches high (4 feet). Please note: Poster presentations may 

not be used as exhibit displays or for marketing purposes, and all posters are subject to approval by 

conference organizers. Only one poster presentation is allowed per registered attendee/author. 


Wednesday, April 3, 2013 (continued) 

11:00 Enabling Flexibility and Speed – Combining Single- 

Use Equipment and Mobile Processing Space to Rapid 

Deployable Process Platforms 

Capital expenses, invested into rigid production facilities, which are often only 

designed to facilitate one product, are a high risk. These are highly inflexible, 

difficult to scale and unable to be divested if the drug target fails. Therefore 

production site design and process equipment flexibility is becoming a key 

element. The presentation will address modular factories, production process 

platforms, single-use equipment, which can be employed fast track and with 

high degree of flexibility. 

Maik W. Jornitz, Vice President, Business Development, 

G-Con LLC, in cooperation with Sartorius Stedim Biotech 

11:30 Advantages and Challenges of Single-Use Systems in 

Biopharmaceutical Development and Manufacturing 

This presentation discusses the advantages and challenges of single-use 

systems in biopharmaceutical development and manufacturing. There are 

a number of systems that Janssen has implemented and the presentation 

discusses our experiences and lessons learned, as well as some thinking 

regarding evaluating single-use vs. more traditional systems. 

John Knighton, Senior Scientific Director, API Large Molecule, Janssen R&D 

12:00 Networking Luncheon with Exhibit and Poster Viewing 

1:10 Chairperson’s Remarks 

Günter Jagschies, Ph.D., Strategic Customer Relations Leader, 

GE Healthcare Life Sciences, Sweden 

What Technologies Are Required to Deliver on the 

Flexible Facility of the Future 

1:15 Single-Use Evolution: Universal Controllers and SmartFactories 

While vertical integration by manufacturers of single-use equipment enables 

them to provide complete facilities, it simultaneously limits future flexibility 

in the purchase of consumables. This talk focuses on the concept of fully 

integrated complete factory automation and data management solutions that 

empower end users to select “best of breed” equipment for all unit operations 

while maintaining the flexibility of changing out equipment in the future. 

Barbara Paldus, Ph.D., Chief Executive Officer, Finesse Solutions 

1:45 Striking the Right Balance of Flexibility: Matching 

Capabilities to Requirements 

There are many approaches to achieving facility flexibility, and the degree 

of flexibility required in an individual facility will vary depending on the 

production requirements and your corporate culture. Mapping an approach 

and achieving the “right” level of flexibility is as much philosophical as it is 

technical. This presentation will present one thought process that can be 

used to weigh the most important considerations, ultimately resulting in a 

flexible facility design which is right for you and your company. 

Günter Jagschies, Ph.D., Strategic Customer Relations Leader, 

GE Healthcare Life Sciences, Sweden 

2:15 Regulatory Considerations of Flexible Facilities and 

Facilities of the Future 

• What are the unique regulatory considerations for hybrid facilities 

• What additional requirements or inspectional considerations might there 

be for fully disposable/single-use facilities 

• For the emerging wave of modular biomanufacturing and multi-unit 

biomanufacturing concepts, do all current facility requirements apply 

How will process consistency be managed across units 

• Can closed processes and open ballroom, flexible biomanufacturing 

concepts go hand in hand 

Session Participants: 

Wallace Lauzon, Ph.D., Senior Evaluator, Cytokines Division, CERB, BGTD, 

Health Canada 

Andrew N. Papas, Ph.D., Director of Regulatory Affairs, Pharmaceutical 

and Biologics Practice, Becker & Associates Consulting, Inc. 

John Godshalk, Senior Consultant, GMP, CMC, Biologics Consulting 

Group, Inc. and Former Reviewer/Inspector, Division of Manufacturing and 

Product Quality, CBER, US FDA 


Hosted by: 

Facility Case Studies and Lessons Learned 

3:45 CASE STUDY Expanding Capabilities in Established Stainless 

Steel Facilities 

This presentation reviews emerging concepts for optimizing the footprint 

of existing facilities to expand manufacturing capabilities and enhance 

operational flexibility. The presentation includes a case study of facility 

modifications made at the Biogen Idec RTP Manufacturing site that increase 

manufacturing flexibility and add single-use capabilities. 

Phillip McDuff, Director, Engineering and Facilities, Biogen Idec 

4:15 CASE STUDY Fit-to-Process Design and Scale-up from Pilot 

to Commercial Manufacture Using Stirred Single-Use 

Bioreactors within a Hybrid Facility 

This presentation discusses how stirred single-use bioreactors (SUBs) 

fit within Lonza to meet the wide-ranging process transfer and scale-up 

requirements of a biopharmaceutical contract manufacturer; milestones 

achieved from evaluation to commercial manufacture including a summary 

of the testing to confirm hydrodynamics, cell culture and product quality 

performance are comparable to stainless steel; a review of current 

performance showing the ability to use SUBs interchangeably with other 

bioreactor types for process development, pilot and mid-scale cGMP 

manufacture; how the design of consumables, platform processes, and 

plant capabilities have all been integrated to enable a synergy of these 

systems, leading to improved standardization; developing a modular 

blueprint for use when upgrading or expanding manufacturing facilities that 

still allows the flexibility required for multi-product manufacture. 

David Valentine, Principle Scientist, Manufacturing Science and Technology 

(MSAT), Lonza Biologics plc, United Kingdom 

4:45 CASE STUDY Cleaning Strategies and Changeover Practices 

for Multi-Product Facilities 

The primary concern with multi-use facilities is the potential for crosscontamination 

of the product at any stage of the manufacturing process, 

and cleaning and changeover strategies must be developed to protect each 

product. Facility design, engineering controls, and operating procedures 

within the facility must work together to minimize this potential. A case 

study will be presented that will highlight what should be considered 

to identify hazards, understand the regulatory considerations and 

expectations, and to gain insight on some of the controls and strategies for 

cleaning and changeover that can be utilized to support a multi-product 

manufacturing facility. 

Michael Parks, Manager, Site Technical Services, Pfizer, Inc. 

5:15 Close of Day Two 

Site Tour to Boehringer Ingelheim’s Fremont, CA Facility 

Wednesday, April 3 • 5:30 pm – 9:00 pm 

Boehringer Ingelheim Fremont is characterized by its exclusive architectural style and 

features extensive use of glass throughout, providing visibility into production suites 

and symbolizing the unique way of open and transparent collaboration with our 

customers. Boehringer Ingelheim BioXcellence invites you to get an insight in our 

new fully disposable state-of-the-art facilities which are ideally suited for the flexible 

development and commercialization of our customer projects. 

Space is limited and available on a first come, first served basis. Pre-registration is 

required, but no additional fee is required. Site visit includes transportation, drinks 

and food reception. 


7:30 Coffee 

Thursday, April 4, 2013 

7:45 Morning Presentation Sponsorship Opportunity 

For more information, please contact Sherry Johnson at sjohnson@ibcusa.com 



Flexible BioFacilities of the Future 

In Association with the BioPhorum Operations Group 

The BioPhorum Operations Group (BPOG) is a 

consortium of senior leaders of the biopharma 

industry who come together to openly share and 

discuss emerging trends and challenges facing their 

industry. With 18 member companies and over 500 

participating representatives, the community primarily 

consists of experts from biopharma drug substance 

operations, who meet and work together to establish best practices on a wide 

range of quality, engineering and organizational subjects that are central to the 

challenge of mastering a biotech drug substance operation. This morning’s sessions 

highlight BPOG initiatives, discussions and best practices in biopharmaceutical 

facility design, technology and implementation. 

8:30 The Changing Face of Biomanufacturing and the Need for 

Flexibility in a Global Marketplace 

The biotechnology industry is experiencing growth in a rapidly changing 

environment, leading to a number of challenges. However, encouraging 

advances in cell biology and new developments in production technology, 

including modular and single use systems, are emerging. From a market point 

of view, we anticipate a stronger focus on personalized medicine and fewer 

blockbusters. We also see emerging countries looking for local production 

facilities. And we also face stretched healthcare budgets which are pressuring 

development and production costs. This presentation discusses Bayer’s view on 

the challenges ahead and in particular, how Bayer, as member of the Biophorum 

group, jointly with other biotech producers, tries to address some of these 

critical topics. 

Joerg Heidrich, Senior Vice President and Global Head Product Supply 

Biotech, Berkeley Site Head, Bayer Healthcare 

9:00 Best Practices Presentations from BPOG Working Groups 

• Continuous Process Verification 

• Human Error Reduction 

• Use of Closed Processing Concepts in Facility Design 

• Standardization of Single-Use components 

10:00 Networking Refreshment Break 

Hosted by: 

10:30 Best Practices Presentations (Continued) 

11:30 Panel Discussion: 

BPOG Best Practices for Biomanufacturing 

• Implementation challenges of new concepts in facility design - ballrooms 

and modular biomanufacturing 

• Overcoming unforeseen difficulties with using disposable technologies in 

facilities of the future 

• Strategies for achieving flexible low cost multi-product facilities 

• Linking innovations to process equipment, new product streams with 

facility of the future concepts 

Moderator: 


Panelists: 

Joerg Heidrich, Senior Vice President and Global Head Product Supply Biotech, 

Berkeley Site Head, Bayer Healthcare 


Wallace Lauzon, Ph.D., Senior Evaluator, Cytokines Division, CERB, BGTD, 

Health Canada 

12:15 Close of Conference 

Sponsorship and Exhibit Opportunities 

Principal Sponsors: 

GE Healthcare Life Sciences provides tools and technologies, 

solutions and expertise which enable the biopharmaceutical 

industry to develop and manufacture biotherapeutic medicines 

and vaccines cost-effectively. Our products and platform 

solutions are designed to meet the key challenges posed at 

every stage in the biomanufacturing process, delivering the desired product at the required purity 

and safety: all with fast development and integrated solutions in mind. Across the bioprocessing 

spectrum, our focus is on supporting you from idea to result. 

Sartorius Stedim Biotech is a leading provider 

of cutting-edge equipment and services for the 

development, quality assurance and production 

processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell 

cultivation, filtration, purification, fluid management and lab technologies are supporting the 

biopharmaceutical industry around the world. Sartorius Stedim Biotech focuses on single-use 

technologies and value-added services to meet the changing technology requirements of the 

industry it serves. Strongly rooted in the scientific community and closely allied with customers and 

technology partners, the company is dedicated to its philosophy of “turning science into solutions.” 

Associate Sponsors: 

Biologics Modular, LLC, designs, manufactures and sells 

modular facilities to serve as self-contained biorepositories, 

biomanufacturing suites and research suites to health science service 

providers, educational facilities and pharmaceutical manufacturers. www.BiologicsModular.com 

The biopharmaceutical contract manufacturer Boehringer Ingelheim 

BioXcellence TM offers tailor-made contract development and 

manufacturing services to the biopharmaceutical industry, providing the 

entire production technology chain from DNA to fill and finish under 

one roof at its facilities in Biberach (Germany), Vienna (Austria) and Fremont (USA). Contact: www. 

bioxcellence.com Email: bioxcellence@boehringer-ingelheim.com 

California-based Finesse Solutions, Inc., has established a proven record 

in providing turnkey, scalable solutions for single-use bioprocessing. The 

Finesse product platform includes an extensive portfolio of novel disposable 

sensors, modular configure-to-order automation hardware, and intelligent software that can 

harmonize global bioprocess information and technology transfer. For more information, please 

visit us at www.finesse.com. 

Gallus BioPharmaceuticals delivers end-to-end biologics process 

development and cGMP drug manufacturing for pre-clinical, clinical 

and commercial products. We empower our customers by accelerating 

time to market through personal collaboration and virtual ownership models driven by advanced 

single-use technologies and sweeping approval from every major regulatory body across the globe. 

The M+W Group brings integrated solutions to process technology, 

automation and complex facility requirements to the life sciences industry 

on a global scale. Whether your firm requires renovation, expansion, or 

turnkey construction of new life science facilities, we will find the best and 

most economical solutions to meet your deadlines. 

Thermo Scientific Cell Culture and BioProcessing products deliver 

proven solutions at every scale. Our products and services are 

specifically designed for performance with innovative, efficient and 

highly effective upstream or downstream applications. From a single source, you can optimize 

production, improve process efficiency and fast track product development and market 

introduction. www.thermoscientifc.com/bioprocessing. 

Corporate Sponsors: 

Make Your Company Known 

DSM Biologics is a contract manufacturer dedicated to mammalian 

development, scale-up and cGMP manufacturing. With more than 

25 years of experience we have flexibility and expertise to achieve 

operational excellence and on-time delivery. 

NNE Pharmaplan is the world’s leading engineering and consulting 

company in the complex field of pharma and biotech. Engineering 

for a healthier world – our role in an industry that improves people’s 

lives worldwide. 

If you are a biopharma CMO, engineering firm or technology provider involved in 

contract manufacturing, facility design, single-use/disposables, modular systems, plug 

and play technologies, facility automation and related technologies you can not afford to 

miss this event. By sponsoring or exhibiting, you will meet thought-leaders and executives 

including VP’s, directors and managers who make facility-related technology and 

outsourcing decisions. Contact us today to reserve your sponsorship or exhibit booth 

and learn about other opportunities to promote your product or service at this event. 

For more information, please contact: 

Sherry Johnson at sjohnson@ibcusa.com or 508-614-1451 


3 

EASY 

WAYS 

TO REGISTER: 

Industry Fees By Dec. 21, 2012 By Jan. 11, 2013 By Feb. 15, 2013 By March15, 2013 

Standard Rate 

After March 15, 2013 

Pharma/Biotech Rate $1799 $1999 $2099 $2199 $2299 

Vendor/Technology Provider/Consultant Rate $2399 $2599 $2699 $2799 $2899 

Academic/Government rate is extended to full-time employees of government, universities and university-affiliated hospitals only. 

Site Visit to Boehringer Ingelheim – Wednesday, April 3, 5:30pm – FREE 

Site visit includes transportation and drinks/food reception. Advance RSVP is requested when registering online at www.IBCLifeSciences.com/Facilities 

Present a Poster to Enhance Your Conference Experience 

All poster presenters must be registered conference attendees. The fee to present a poster in addition to your conference registration is: 

Vendors/Supplier*: $300 Pharma/Biotech: $100 Academic/Government: FREE 

* Vendor rate is for exhibiting/sponsoring companies and/or posters that upon review are of commercial/product focus 

Ways to Save on 

Your Conference Registration 

Register Early: 

The earlier you register the higher the discount and the more you will save! 

Send a group of 3 and the 4th goes FREE! 

It’s a fact – attendees walk away with the most value when they experience 

it with a peer – there is just too much information available for one person 

to capture it all. As a result, we are pleased to offer a 4th free registration 

when you register 3 people at the standard rate at the same time. For more 

information call our group sales advocate at 646-895-7445. 

Academic and Government Special Rates 

Full-time employees of a government organization, universities and 

university-affiliated hospitals are eligible to take advantage of over a 40% 

savings off industry rates. 

Your Colleague Is Speaking at this Conference 

If you are from a company that is already sending another person to 

present at this conference, you qualify for a 20% discount off the standard 

rate. Contact your colleague who is speaking for their discount code. 

Your Company Is Exhibiting or Sponsoring this Event 

If you are from a company that is exhibiting or sponsoring this event, you 

qualify for a 20% discount off the standard rate. Contact your marketing 

person for the discount code. 

Event Partners: 

CALL 

800.390.4078 or 

+1.941.554.3500 

BioPhorum Operations Group (BPOG) is a cross-industry 

collaboration with the aim of sharing operational best practices 

in biopharmaceutical manufacturing. Our goal is to help 

accelerate the rate at which the industry attains a lean state, 

focusing on emerging industry challenges, importing and 

customising external best practice. www.biophorum.com 

@ 

EMAIL 

reg@ibcusa.com 

WEB 

www.IBCLifeSciences.com/Facilities 

Priority Code: B13501pdfwdl 

Venue and Accommodations 

W San Francisco 

181 3rd Street, San Francisco, CA 94103 

Tel: (415) 777-5300 • Fax: (415) 817-7823 

Room Reservations: 1.877.822.0000 

www.whotels.com/SanFrancisco 

Please call the hotel directly at the numbers above before 

Friday, March 8, 2013 to be included in IBC's dedicated 

room block for this conference. Please identify yourself as a 

participant in IBC’s Flexible Facilities conference to receive 

the reduced room rate. Be sure to make you reservations as 

soon as possible as rooms tend to fill up very quickly and all 

reservations are subject to availability. 

Additional Registration Information 

For onsite registrations, please add $100. 

Program content and speakers subject to change. Conference badges are non-transferable and lost 

badges will not be replaced without payment of the full conference registration fee. 

Please note that payment is required in advance of the conference. Please make check(s) (in U.S. 

funds drawn on a U.S. bank) payable to IBC Life Sciences and attach to the registration form. 

Confirmation of your booking will be sent. Should you elect to pay by MasterCard, Visa or American 

Express, please send your credit card number, expiration date, name as it appears on card and 

signature along with the registration form. 

Registration Substitutions/Cancellations: If you need to make any changes or have any questions, 

please feel free to contact IBC’s customer service team via email at reg@ibcusa.com. Cancellations 

must be in writing and must be received by IBC prior to 10 business days before the start of the 

event. Upon receipt of a timely cancellation notice, IBC will issue a credit voucher for the full amount 

of your payment, which may be applied towards registration fees at any future IBC event held within 

6 months after issuance (the “Expiration Date”). All credit vouchers shall automatically expire on 

the Expiration Date and shall thereupon become void. In lieu of issuance of a credit voucher, at 

your request, IBC will issue a refund less a $595 processing fee per registration. Registrants are 

advised that no credit vouchers or refunds will be issued for cancellations received 10 business days 

or less prior to start of the event, including cancellations due to weather or other causes beyond 

the Registrant’s control. IBC therefore recommends that registrants allow for unexpected delays in 

making travel plans. Substitutions are welcome at any time. If for any reason IBC decides to cancel 

this conference, IBC accepts no responsibility for covering airfare, hotel or other costs incurred by 

registrants, including attendees, sponsors, speakers and guests. 

SPECIAL NEEDS: If you have a disability or special dietary needs, please let us know in 

order that we may address your special needs for your attendance at this show. 

Please send your special needs via email to custserv@ibcusa.com. 

IBC’s 10th Annual 

Single-Use Applications for 

Biopharmaceutical Manufacturing 

Innovations in Single Use Technologies for Downstream Processing, 

Continuous Manufacturing and Flexible Facilities 

June 3-5, 2013 • Durham Convention Center • Durham, NC 

Join us at THE Meeting Place for scientists, engineers and professionals in the singleuse 

space to hear about current trends and next frontiers in single-use applications; 

see the new product launches by leading vendors and network with the industry’s 

leading experts - from drug developers to contract manufacturers to single-use 

component developers and vendors. Sign up for our email updates at 

www.ibclifesciences.com/singleuse. 

Publication Partner: 

Flexible Manufacturing: Strategies for 

Supplying Complex Biologics 

Scan the QR code or visit the 

iTunes App Store and search for 

BioProcess International to download 

this special BPIMobile edition 


IBC Life Sciences Presents State-of-the-Art… 

Flexible 

Facilities 

April 2-4, 2013 • The W Hotel • San Francisco, CA 

One Research Drive, Suite 400A 

Westborough, MA 01581, U.S.A. B13501M 

PRST STD 

US POSTAGE 

PAID 

VILLANTI 

If you have changed roles at your company or are unable to make it to this event, please pass this along to someone else 

at your company who might be interested in attending. 

Incorrect Mailing Information: If you are receiving multiple mailings, have updated information or would like to be removed from our database, 

please contact our database team at 646-895-7417. Please keep in mind that amendments can take up to 6 weeks. 

Are Your Facilities and 

CMO’s Prepared for… 

• Multi-product/Multi-use Facilities 

• On-Demand Scale-Up/Scale-Down 

• Mobile and Modular Concepts 

• Implementation of Single-Use 

• Diverse Products: Vaccines, mAbs 

• Clinical and Commercial Flexibility 

• Rapid Facility Deployment 

• Regulatory, Quality & Technical Risks 

Solutions for Multi-Product Pipelines, Global Markets, 

On-Demand Scale-Up/Scale-Down and Capacity Optimization 

Hear Perspectives from Regulatory and BARDA to Inform Your Bioproduction and Facility Strategies 

Wallace Lauzon. Ph.D., Senior 

Evaluator, Cytokines Division, CERB, 

BGTD, Health Canada 

Robin Robinson, Ph.D., Director, Biomedical Advanced 

Research and Development Authority (BARDA); 

Deputy Assistant Secretary for Preparedness & Response, 

U.S. Department of Health and Human Services 

Maximize Facility Efficiency 

with Best Practices from BioPhorum 

Operations Group (BPOG) 

Consortium Working Groups 

Boehringer Ingelheim 

Facility Tour 

See BI’s state-of-the-art 

facility first-hand! 

www.IBCLifeSciences.com/Facilities

Flexible Facilities

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