BioProcess International Conference & Exposition

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Conference: October 26-29, 2015 * Exposition:  October 27-29, 2015 * John B Hynes Veterans Memorial Convention Center, Boston, MA

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THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality

Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 · John B Hynes Veterans Memorial Convention Center · Boston, MA

Manufacturing Strategy

Manufacturing Strategy

Manufacturing Strategy

Biomanufacturing experts share strategies to maximize efficiencies and cost savings across your manufacturing network through implementation of disruptive technologies, operational excellence and new facility concepts. Learn how to develop your manufacturing infrastructure so you can remain flexible to the production needs of a diverse pipeline of novel biologic molecules in a multiproduct environment.

Topics include:

  • Operational efficiency, facility optimization, process economics and manufacturing portfolio planning
  • Manufacturing technologies and case studies to increase efficiency in clinical or commercial production
  • Single-use technology implementation case studies (clinical and commercial)
  • Biomanufacturing of emerging modalities and complex molecules
  • Continuous processing and continuous biomanufacturing

Tuesday, October 27, 2015

7:00
Registration and Coffee

8:00
Chairperson's Remarks
Richard Reineke, Director, Upstream Manufacturing, Amgen, Inc.

Strategies to Ensure Manufacturing Efficiency and Quality

8:15
A Holistic Approach to Developing a Robust Drug Product Manufacturing Process that Ensures Consistent Product Quality Attributes
Ensuring consistent product quality attributes for a given manufacturing process begins with an understanding of the clinical design. The clinical design enables a quality target product profile (patient centered), which forms the basis for developing a robust manufacturing process, encompassing drug substance, formulation excipients, package components, formulation composition, manufacturing process, in-process testing, product specifications, and supply chain.
Ganapathy Gopalrathnam, Senior Research Scientist, Bioproduct Pharma Design/Formulations, Eli Lilly & Company

8:45
A Successful Lean Manufacturing System in a Biologics Manufacturing Plant
Can biologics DS supply be reliable and cost-reduced? Do operators connect daily performance to quality and cost? Are new product introductions too slow? A successful lean manufacturing system at Amgen Rhode Island has decreased cost, reduced errors and increased speed. New daily practices have reduced scrap, increased reliability and improved yields. Well-trained operators, purposeful presence and a safety-first culture have decreased non-conformances and improved new product introductions.
Richard Reineke, Director, Upstream Manufacturing, Amgen, Inc.

9:15
A Life Cycle Approach to Managing Risk throughout the Design, Qualification, and Operation of Manufacturing Systems
Risk management is most effective when used prospectively during product development and process design, when design and control systems are easily modified to reduce risk and improve product quality. Building quality into drug product manufacturing processes up front is better than testing these products for defects later. The use of risk management to design, qualify, and operate systems used in manufacturing processes is beneficial.
Ghada Haddad, Director, Engineering, Sterile & Validation CoE, Merck & Co.

9:45
Networking Refreshment Break

New Concepts in Facility Design and Biotherapeutic Production

10:15
Process Simulation and Facility Modeling: Identification of Increased Throughput Enabling Projects in a Complex Multiproduct Manufacturing Environment
Biogen's portfolio of drug substance process/facility models is used to analyze multi-product manufacturing scenarios. Models are leveraged to identify potential capital projects that can directly increase facility throughput and quantify relative impact of "competing" projects (i.e. reductions in product changeover time vs. reductions in batch to batch turnaround times).
Suzanne Stuhler, Senior Process Engineer, Operations Technology & Innovation, Biogen

10:45
The Automated Swiss Large Scale Biologics Manufacturing Facility
Dominik Wegmann, Ph.D., Head of Manufacturing Science & Technology, Biological Production, Lonza AG, Switzerland

11:15
Therapeutic Protein Production On-Demand
In a paradigm shift from the conventional large scale therapeutic protein manufacture at a site distant from the end user, our team has been developing a compact, agile platform designed to produce therapeutic proteins at the point-of-care. In this presentation, we will describe our progress towards making a briefcase size device that will serve as the factory of the future and enable biologics production on-demand at the point-of-care. Our core technology uses a novel CHO cell extract for in vitro expression of virtually any protein and couples it with a simple, single step intein-based purification system that has the potential of producing a therapeutic ready for delivery to the patient. This entire device and process are being robustly validated by analytics and regulatory teams. Case studies based on the production of Streptokinase and Erythopoietin will be demonstrated.
Govind Rao, Ph.D., Professor and Director, Center for Advanced Sensor Technology, University of Maryland, Baltimore County

Concurrent Technology Workshops

11:50
From Continuous Manufacturing Approaches for Single-Use Manufacturing
Christel Fenge, Vice President of Marketing for Fermentation, Sartorius Stedim North America

Optimal and Consistent Protein Glycosylation in Biosimilar Production
William G. Whitford, Senior Manager, Cell Culture, GE Healthcare

CQA Impurity Monitoring for Integrated Bioprocessing
This contribution proposes a novel approach using direct measurements of Critical Quality Attributes (CQA). We propose a CQA analyzer, which is based on a HPLC principle combined monolithic columns, which is used horizontally along the entire process, from upstream to downstream processing. Together with advanced multivariate data analysis algorithms, the chromatogram can be used as a fingerprinting method, allowing to track host cell impurities CQAs in a timely controlled way. Hence we present a PAT tool as per original definition.
Dr. Christoph Herwig, Professor of Biochemical Engineering, Vienna University of Technology, Austria

Rapid Production of Recombinant Proteins and Stable Cell Lines at Different Scales
Weili Wang, Ph.D., Principal Scientist, Protein Production, MaxCyte

Luncheon Presentations

12:20
Presentation TBA

Presentation TBA

1:25
Chairperson's Remarks
Seongkyu Yoon, Ph.D., Assistant Professor and Director, Massachusetts Biomanufacturing Center, University of Massachusetts Lowell

Continuous Processing and Building in Manufacturability

1:30
A.S.A.P (Automated Seamless Antibodies Purification): Toward a Fully-disposable and Continuous Process
A new purification process has been developed in Bioprocesses Vitry, enabling to run 3 chromatography steps in continuous mode with no holding time nor open phase. A cell culture bulk containing the Monoclonal Antibody can be now fully processed through this continuous process to obtain a pure Monoclonal Antibody batch without human intervention, decreasing also resin and buffer costs. New updates were added to enable the use of membrane absorbers and become a fully disposable process.
Benoit Mothes, Scientific and Innovation DSP Head, Bioprocess Science and Technologies Department, Sanofi, France

2:00
Continuous Biomanufacturing: The Future of Antibody Production
We present a rapid continuous biomanufacturing platform process that combines a perfusion mammalian cell culture with a synchronized purification of the antibodies produced without the use of intermediate holding tanks or surge bags. The bioreactor is connected to a cell retention device and optimized to 1 (vvd) or less while immediate recovery and purification of the antibody is obtained using a single Protein A column bysynchronizing the rate of perfusion with the antibody capture. This approach offers a cost effective and flexible platform process for the manufacture of both stable and unstable therapeutic agents.
Seongkyu Yoon, Ph.D., Assistant Professor and Director, Massachusetts Biomanufacturing Center, University of Massachusetts Lowell

2:30
Manufacturability Considerations during the Development of a Phase III Cell Culture Process for the Production of an IgG4 Antibody
This presentation describes our systematic approach of building manufacturability into a Phase III cell culture process for the production of an IgG4 antibody using a cholesterol dependent NS0 cell line. In particularly, we will discuss a novel approach that was developed to control half antibody impurity, a critical quality attribute for this molecule, as well as progress made to address facility fit, improve productivity and reduce process complexity.
Marcella Yu, Ph.D., Staff Scientist II, Commercial Cell Culture Development, Genzyme, a Sanofi Company

3:00
Short Break to Move to Keynote Session

Keynote Presentations

3:10
Chairperson's Remarks

3:15
David J. Pollard, Ph.D. Innovating mAb Production to Support the Immunotherapy Revolution
A new paradigm in cancer therapy is emerging with the recent success of the antibody mediated, immune tumor killing response for melanoma. Evaluations have expanded to include a range of tumor types. In addition new alternatives and combinations are aimed at improving patient non responsiveness to PD-1. These foundational efforts of emerging cancer treatment need to be supported by agile antibody supply solutions that meet the capacity demands, while improving global access and lowering costs. Technology solutions have been implemented to speed process development and shorten the critical time to first in human clinical studies. Innovative approaches towards the 'process of the future' will be shown that support flexible multi product lower cost manufacturing. Continuous processing enabled by single use provides an integrated solution and the implementation challenges will be discussed.
David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc.

3:45
Spencer Fisk Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics
The movement of a large portfolio, consisting of a broad spectrum of biological molecule-modalities, requires seamless integration from the research bench to the clinic. Deep alignment and partnership between the Research and the Process/Analytics functions allows for rapid and systematic product candidate screening, eliminating the most problematic candidates. Combining state-of-the-art cell lines with a regimented application of robust high-throughput process and analytical development packages enables record speeds to the first patient with minimal resources.
Spencer Fisk, Global Head, Biologics Process R&D, Novartis Pharma AG, Switzerland

4:15
Michael Anthony (Tony) Moody, M.D. Novel Approach to Developing and Producing Human Experimental Vaccines for HIV
Michael Anthony (Tony) Moody, M.D., Chief Medical Officer, Associate Professor of Pediatrics, Duke Human

4:45
Trick or Treat! Halloween Reception and Exposition Hall Grand Opening
The opening night reception sponsored by Roche will feature a Halloween theme complete with a fun and festive ambiance. Come and enjoy Halloween-inspired food, drinks, decorations and games while networking with exhibitors, poster presenters and other attendees in the exposition hall.

Wednesday, October 28, 2015

7:30
Registration and Coffee

Technology Workshop with Light Continental Breakfast

7:45
Presentation TBA

8:30
Chairperson's Remarks

Keynote Presentations

8:35
Kimball Hall Amgen's Next-Generation Biomanufacturing Facility
Described here is the establishment of a biomanufacturing platform for the production of biologic medicines. Competitive product portfolios that can respond quickly to changes in market dynamics have necessitated optimization of production strategies. The "Next-Generation Biomanufacturing" platform allows for fast and flexible drug operations for synthesis of drug substance in a reconfigurable manufacturing system. Key enabling technologies include modular construction, single-use bioreactors, disposable plastic containers, continuous purification processing and real-time quality analysis. Amgen's Next-Generation Biomanufacturing changes the way we will manufacture in the 21st Century.
Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd.

9:15
Konstantin Konstantinov, Ph.D. What is the Future of Continuous Processing - What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme

9:45
Networking Refreshment Break in Exposition Hall Sponsored by:

10:25
Chairperson's Remarks
Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global Process Owner, Biogen

Raw Material Control, Change Notification and Supplier Management

10:30
Raw Material Control: A CMO Perspective on an Industrial Challenge
Based on regulatory guidances and advanced quality risk management practices, the biopharmaceutical industry is greatly focused on enhancing process robustness to ensure product quality. Development of an effective raw material characterization strategy is vital to achieving this objective. Through definition and examples, the approach currently being developed by Lonza Biologics for minimizing raw material variability for improvement of large-scale upstream operations will be discussed.
Seshu Tummala, Ph.D., Principal Scientist, Research and Technology, Lonza Biologics, Inc.

10:55
Importing Best Practice into Raw Material Change Notification
The way raw material change notifications are communicated in the biopharmaceutical industry often causes anguish and significant extra work for both suppliers and end users. Often, changes take too long to assess and there is a growing consensus that greater clarity and guidance would be beneficial on both the type of changes requiring advanced notice and the information needed for impact and risk assessment. A group of BPOG member companies are working together and with suppliers to develop such guidance. As part of this study they have reviewed the change notification solutions used in the aerospace, automotive and semi-conductor industries with the intention of importing best practice. This presentation will outline the team's work and their plans on this common challenge for us all.
Shamini Nathen, Senior Quality Engineer, Bristol Myers Squibb

11:20
Innovation Development within a Strategic Supplier Program
The biopharmaceutical industry is developing increasingly stringent demands on the quality and consistency of the raw materials used in their manufacturing. To manage this complexity, many large pharmaceutical organizations are creating strategic supplier relationship programs to focus their development activities. This presentation will discuss strategies to manage a strategic supplier innovation pipeline that preserves the freedom to operate for both organizations and creates valuable solutions which can be broadly disseminated across the industry.
Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global Process Owner, Biogen

11:40
Solving the Genealogy Puzzle in Biologics Manufacturing
Data is being generated at all steps of biologics manufacturing from raw material suppliers through finished goods - but splits and joins in the process genealogy add tremendous complexity, which needs to be overcome in order to leverage all the data available. How can Data Science can help?
Gabe Josset, Senior Associate Scientist, Process Informatics, Biogen

Concurrent Technology Workshops

12:05
Case Study
Using Process and Activity to Drive Clone Selection
Oren E. Beske, Ph.D., COO, Aragen Bioscience, Inc

Single-Use Fermentation: Understanding Process Economy and Process Performance
Kenneth Clapp, Senior Global Product Manager, Bioreactors, GE Healthcare

An Insight into Recent Developments in Protein A Chromatography
Jonathan Royce, Senior Product Manager, Bioprocess Product Marketing - Downstream, GE Healthcare

Case StudyNew Data
Comparison of Methods and Materials for Single Use Bag Extractable Testing
This study highlights the relationship between two extractable test methods and the materials of construction of single use bag systems. The data show that the BioPhorum Operations Group (BPOG) protocol may not be sufficient as a single method for detecting extractables from single use bag systems, and that use of advanced materials like fluoropolymers allows more robust extractable detection methods.
Mike W. Johnson, Global Bioprocess Applications Manager for Life Sciences, Entegris, Inc

Presentation TBA
JSR Life Sciences

12:35
Networking Luncheon in the Exposition Hall

1:40
Chairperson's Remarks
Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom

Continued Process Verification Strategies for Biologics

1:45
Condensed Playbook for Continued Process Verification (CPV)
Following the well-received publication of the BioPhorum Operation Group's (BPOG) CPV Case Study, the BPOG CPV team has created a 'playbook' or step-by-step guide to the implementation of CPV in table form. The guide aligns with the FDA's product lifecycle model and refers to a flow diagram. The aim is to make implementing CPV an activity that is accessible to everyone in the Biopharmaceutical Operations environment. This presentation will describe the playbook, and how to access and use it.
Marcus Boyer, Ph.D., Associate Director of Process Life-cycle Management, Bristol-Myers Squibb

2:15
Continued Process Verification (CPV) Informatics Systems and Validation
Fundamentally, the purpose of informatics system validation is to ensure a sufficient level of data integrity. In the case of Continued Process Verification (CPV), validation is complicated by the need to pull data from a number of source systems. The CPV Informatics system is essentially one that enacts data gathering processes and it is essential that the governance models for source systems are understood when the CPV system is set up. Validating efficiently, through risk assessment and justified approaches is essential, given the potentially massive informatics testing requirements for activities like CPV. Useful approaches will be highlighted in this presentation. It needs to be recognized that a CPV Informatics system will be subjected to changes after it has been released for use, and means of managing change will be part of this presentation.
Carly Cox, Senior Process Engineer, Pfizer

2:45
Implementing Continued Process Verification (CPV) for Legacy Products
In 2014, the BioPhorum Operations Group published the CPV Case Study, detailing how CPV plans can be created, with a focus on new products. Subsequently, the BPOG CPV team has considered the case of legacy products and this presentation covers their findings. It will include: the gathering and use of existing manufacturing data, the discovery of previous trends and management across multiple sites amongst other topics.
Bert Frohlich, Ph.D., Director, Process Controls and Quality by Design, Manufacturing Sciences & Technology, Shire

3:15
Networking Refreshment Break in the Exposition Hall Sponsored by:

Manufacturing Strategies for Legacy Products

4:00
Building a Process Improvement Strategy for a Legacy Biologics Process Which Enables Implementation of a Next Generation Process
Balancing the more pressing needs of a current process with the more strategic needs of a future generation is a daunting task, it can be especially difficult when improving a legacy process. Technical agendas can easily be too narrow, failing to enable necessary design space knowledge or performance enhancements that can be a bridge to the next generation. This is a case study of a plan that attempts to balance the needs of both.
Amanda Ashcraft, Manager, Process Engineering Development, Manufacturing Technical Support, Genzyme

Regulatory Perspectives on Legacy Products and Post-Approval Manufacturing Changes

4:30
Regulatory Perspectives on Legacy Products
Legacy products are typically those that have been on the market for a decade or more. Legacy products exist because they continue to play an important role in the ongoing treatment of patients. Typically, there are few CMC changes for these products over time unless a safety issue is identified and acted upon either by the sponsor or the regulator. The balance between updating manufacturing and control strategies to better reflect current expectations and the risk to the approval status of the legacy product is currently very conservative. The Canadian regulatory experience with legacy products will be discussed.
Nancy Green, Ph.D., Chief, Hormones and Enzymes Division, CERB, BGTD, Health Canada

5:00
Regulatory Perspective on Post-Approval Manufacturing Changes
Canada has a risk-based program to determine the reporting requirements for post-approval manufacturing changes. Reporting varies between filing an annual notification of a change to a filing a supplemental New Drug Submission with supporting non-clinical and/or clinical information. In order to help sponsors determine the appropriate filing level and information requirements, Health Canada has an updated and expanded guidance, the Post-Notice of Compliance Changes Guidance available for consultation. The Canadian experience in using the guidance will be discussed.
Speaker TBA, Health Canada

5:30
Casino Night Networking Reception in the Exposition Hall
Feeling lucky? Wednesday night's Networking Reception in the Exposition Hall will feature a Casino Night theme where attendees can try their luck at classic casino games like Blackjack, the Big Six Wheel, and Poker. Co-Sponsored by: and

Thursday, October 29, 2015

7:00

Bioprocess "Problem-Solving" Discussion Topics and Moderators

These moderated discussions on a variety of bioprocess topics will allow you to share strategies and brainstorm solutions in an informal, small group setting.
  • QbD for Analytical Methods: Sharing Experiences and Approaches
    Kazumi Kobayashi, Ph.D., Senior Principal Scientist, Technical Development, Biogen
  • Single-use and Disposable Technologies in Bioprocess Development
    Wallace Lauzon, Ph.D., Senior Evaluator, Cytokines Division, CERB, BGTD, Health Canada
  • Regulatory Perspectives on Aging Facilities
    Nancy Green, Ph.D., Chief, Hormones and Enzymes Division, CERB, BGTD, Health Canada
  • Inspection Trends Summary
    Jeffrey Skene, Chief, Monoclonal Antibodies Division, CERB, BGTD, Health Canada
  • Regulatory Perspectives on CMC Submissions
    Health Canada Regulator TBA
  • Particulate Defects - Critical versus Minor
    Kevin Kerls, Inspection MSAT, Hillsboro Technical Operations, Genentech, Inc. - A Member of the Roche Group
  • Opportunities and Challenges of High Concentration Biologics
    Mark Moody, Ph.D., Chief Scientific Advisor, ReForm Biologics
  • Developability and Development: Improving the Outcome
    Valentyn Antochshuk, Ph.D., Principal Scientist, Group Leader, Formulation Design and Process Compatibility, Merck & Co.
  • Container Closure Integrity Testing and Technology
    Kevin M. Maloney, Ph.D., Principal Scientist, Technical Development, Biogen
  • Raw Materials Management in Biologics Production
    Dave Kolwyck, Director, Manufacturing Sciences, Raw Material Global, Process Owner, Biogen
If you are interested in proposing or moderating a discussion topic in this breakfast session, please email at Michael Keenan mkeenan@ibcusa.com.

8:00
Chairperson's Remarks
Lisa Bradbury, Ph.D., Director, Pall Corporation

Closed System Manufacturing

8:15
Case Study
ADC Production: Integration of the Conjugation Step in a Standard Protein Plant Using Closed Systems
ADC manufacturing in most cases uses 2 separate facilities for production, a protein plant with its typical segregation and a special toxin conjugation facility to produce the ADC drug substance. This talk will describe a set-up to do the toxin conjugation within the footprint of a downstream suite of a standard protein plant. The prerequisites to achieve that such as closed systems operation, using disposables as well as isolator technology for the conjugation part will be described in detail.
Berthold Boedeker, Ph.D., Chief Scientist, Global Biologics, Biotech Development, Bayer Pharma AG, Germany

8:45
Closed Processing and Sanitizing Temporary Openings
Closed processing in controlled, non-classified spaces mitigates risks associated with contaminants in the manufacturing environment whilst improving quality. Significant benefits can be gained in simplified facility designs and low levels of environmental control. However, advances in closed processing technology have not completely eliminated the need to temporarily open systems and it is impractical to use typical procedures for closure. To address this issue, the Biophorum Operations Group (BPOG) have collaborated with the Biotechnology Training and Education Centre (BTEC) to establish whether liquid sanitization can be used to effectively close a temporary opening in an otherwise closed system. A series of tests have been undertaken, using equipment that closely models real processing conditions. This presentation will report on these tests.
Kavita Ramalingam Iyer, Ph.D., Senior Specialist, Global Regulatory Affairs, Vaccine-CMC, Merck Sharp & Dohme Corp.

9:15
Presentation Sponsorship Opportunity
If you have a manufacturing related case study or technology and are interested in sponsoring a presentation in this session, please contact Jennifer Wicket at jwickett@ibcusa.com or Kristen Schott at kschott@ibcusa.com

Networking Refreshment Break in the Exposition Hall Sponsored by:

Practical Experiences from Single-use Technology Implementation

10:30
Design of a Clinical Manufacturing Facility Strategically Aligning Single-use and Fixed Equipment
The presentation will describe the design of a biologics clinical manufacturing facility that integrates single-use and stainless steel equipment strategically to take advantage of the strengths of both. Single-use bioreactors provide several advantages. Among them are: (1) Less capital and validation investments, (2) Flexibility, and (3) Quicker turnaround between batches. Single-use mixing systems provide similar advantages in terms of the initial capital layout and turnaround times. The facility will integrate single-use bioreactor and mixing systems with conventional stainless steel centrifuge and chromatography skids to take advantage of the latest technological advancements. The presentation will also describe the design philosophy for the facility incorporating optimum process, material and personnel flow as well as area classifications meeting the latest compliance requirements.
Sourav Kundu, Ph.D., Director, Biopharmaceutical Development, Teva Biopharmaceutical, USA

11:00
Considerations for Technology Transfer from Single-use to Stainless
Single-use manufacturing has been increasingly implemented in the recent years in the biotech industry for early phase clinical production. As programs advance, larger volume production is needed and traditional stainless technology is used. We will review considerations for technology transfer from single-use to stainless technology.
Anna Pisania, Ph.D., Staff Engineer, Acceleron

11:30
Implementing Flexible Manufacturing & Single-Use Systems in Upstream Processing
Speaker TBA

12:05
Technology Workshops
Have Your Presentation Included Here! Contact Jennifer Wickett (companies A-L) at jwickett@ibcusa.com or Kristen Schott (companies M-Z) at kschott@ibcusa.com for details.

12:35
Networking Luncheon and Last Chance for Exposition Hall Viewing

1:55
Introduction of Groups, Members and Status of Collaborations
Tony White, Director, BioPhorum Operations Group (BPOG)
Kevin Ott, Executive Director, Bio-Process Systems Alliance (BPSA)

Single-Use Technologies and Applications:
A Coordinated View from Industry Consortia

2:10
Change Notification Allied Efforts
BPOG and BPSA Speakers TBA

2:35
User Requirements: A User Perspective
BPOG Speaker TBA

3:00
Networking Refreshment Break

Single-Use Technologies and Applications:
A Coordinated View from Industry Consortia

3:30
Extractables Test Methods: Progress Towards a Standard
BPOG and BPSA Speakers TBA

3:45
BPSA's 2015 Single-Use Quality Test Matrices Guide
BPSA Speaker TBA

4:15
NEW! Town Hall Forum DiscussionSingle-Use Standardization: Progress in Improved Alignment of Guidelines
Moderator: James Dean Vogel, Founder and Director, The BioProcess Institute
BPOG Perspective: Tony White, Director, BioPhorum Operations Group
BPSA Perspective: James Dean Vogel, Founder and Director, The BioProcess Institute
PDA Perspective: Robert Repetto, Senior Director, External Affairs, Pfizer
ASTM Perspective: Robert Steininger II, ASTM SubCommittee Chairman, Biotechnology and Consultant, BioPE, LLC
ASME/BPE Perspective: Jay Ankers, Director of Technology, M+W Group

5:00
Close of Conference

Charles River
BPI China

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