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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  • Japanese
  • Korean
  • Taiwanese
  • Chinese
  • English

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

Pre-Conference Symposia Agenda

Pre-Conference Symposia Agenda

Pre-Conference Symposia

Monday, October 26, 2015 · Pre-Conference Symposia

Symposium #1

Cell Therapy Bioprocessing

8:30
Chairperson's Opening Remarks and State of the Industry Address
Anthony Davies, President, Dark Horse Consulting

Cell Therapy Process Development

9:00
Automated iPSC Culture Process
Wen Bo Wang, Ph.D., Vice President, Process Sciences, Cellular Dynamics International

9:30
Solutions to Process and Technology Bottlenecks
Nick Timmins, Ph.D., Director, Product and Process Development, Centre for Commercialization of Regenerative Medicine (invited)

10:00
Networking Refreshment Break

Tools and Technologies

10:30
Presentation Sponsorship Opportunity
If you have a novel cell therapy 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

11:00
Advancing the CRISPR/Cas9 Technology Platform for Therapeutic Applications
Grant Welstead, Ph.D., Research Scientist, Editas Medicine

Featured Presentation

11:30
Update on Japan's New Regulations - What is Going on in Japan and How Will it Impact the Rest of the World?
David Hall, CEO & President, RepliCel Life Sciences

12:00
Networking Luncheon

12:55
Chairperson's Remarks
Harvey Brandwein, Vice President, Business Development, Pall Corporation

Overcoming the Challenges of Manufacturing and Tech Transfer

1:00
Allogeneic Cell Therapy Manufacturing Process Design: A Rational Approach
Harvey Brandwein, Vice President, Business Development, Pall Corporation

1:30
New Data
Development of a Lentiviral Vector Production Process by Transient Transfection in Serum-Free Suspension Culture for CAR-T Immunotherapy
Qi Wei, Ph.D., Senior Scientist, Cell and Gene Therapy, Novartis

2:00
New Data
Developing Novel Methods for Maintenance of Pluripotency in ESC During Expansion and Improvement of Directed Differentiation of OPCs
Eric Whitely, Ph.D., Director of Development, Asterias Biotherapeutics

3:00
Networking Refreshment Break

Characterization and Setting Specifications

3:30
Evolving Cell Characterization Profiles in Moving Adult Stem Cells Toward Commercialization
Robert J. Deans, Ph.D., Executive Vice President, Regenerative Medicine, Athersys, Inc. (invited)

4:00
Justification of Specifications
Christopher A. Bravery, Ph.D., Director, Consulting on Advanced Biologicals Ltd., United Kingdom

4:30
Panel Discussion - Overcoming Obstacles in Cell Therapy Cell Manufacturing
Moderator: Jason N. Carstens, Ph.D., Director, Process Development, Fred Hutchinson Cancer Research Center (invited)

5:00
Close of Symposium

Symposium #2

ADC Development & Production

9:00
Chairperson's Opening Remarks
Pranhitha Reddy, Ph.D., Consultant, Gene to BLA, LLC

New Modalities and Next Generation ADCs

Featured Presentation

9:15
New Payloads for ADCs: Challenges and Advantages
Ravi J. Chari, Ph.D., Executive Director, Chemistry and Biochemistry, ImmunoGen, Inc.

9:45
ADCs: Leveraging Shared Learnings to Enable Next Generation Success
Alan C. Rigby, Ph.D., Vice President, ADC Biology, Eli Lilly and Company

10:15
New Data
Expressed Protein Ligation as a Bioconjugation Platform
Oliver R. Thiel, Ph.D., Principal Scientist, Process Development, Amgen Inc.

10:45
Networking Refreshment Break

Controlling the Drug Loading and Heterogeneity

11:15
Case StudyNew Data
Overcoming Challenges and Enhancing Production of Antibodies for Site-Specific Antibody-Drug Conjugates
Marie Zhu, Ph.D., Director of Process Sciences & Manufacturing, Agensys Inc.

11:45
Case Study
Tuning the Efficacy of Antibody Drug Conjugates Via Site-Selective Conjugation
Alan Wahl, Ph.D., Vice President, Research and Discovery, Ambrx, Inc.

12:15
Networking Luncheon

1:55
Chairperson's Remarks
Michael Sun, Ph.D., Director, Purification & Conjugation Development, Seattle Genetics, Inc. (invited)

Technology Transfer and Supply Chain

2:00
Transitioning Antibody Drug Conjugate Programs from Research to Development and Beyond
Vincent Turula, Ph.D., MBA, Director, Biotherapeutics Pharmaceutical Sciences, Pfizer Inc.

2:30
Ensuring Supply Chain - Challenges of Safeguarding Flow of Raw Materials
Evan Greger, MBA, Global Head, Biopharmaceutical Operations, Manufacturing Sciences and Technology, Novartis (invited)

3:00
Networking Refreshment Break

Ensuring Process and Product Quality

3:30
Impact on New Linker Payloads on Drug Substance Quality Attributes and Process Solutions
Olivier Marcq, Ph.D., Senior Principal Scientist, Pfizer Biotherapeutics R&D, Pfizer (invited)

4:00
Leveraging Molecule and Process Understanding to Control Product Quality
Pranhitha Reddy, Ph.D., Consultant, Gene to BLA, LLC

4:30
Strategies for Setting Specifications
Gillian Payne, Ph.D., Senior Director, Bioanalytical Sciences, ImmunoGen, Inc.

5:00
Close of Symposium

Symposium #3

Innovation In Process and Product Development Technologies for Biopharmaceutical Development

Any registered attendee may attend this symposium at no additional charge.

9:00
Chairperson's Opening Remarks
Abhinav Shukla, Ph.D., Vice President, Process Development & Manufacturing, KBI BioPharma

9:15
Alternatives and Innovations in Technologies in Drug Substance Process Development
Chetan Goudar, Ph.D., Director, Pre-Pivotal Drug Substance Process Development, Amgen

9:45
Tools, Technologies, and Business Practices that can Accelerate the Pace of Biopharmaceutical Development
Andrew Tustian, Ph.D., Senior Scientist, Regeneron, Inc.

10:15
Innovation in mAb Processes for Companion Pets
Michael J Dupuis, Ph.D., Senior Principal Scientist, Zoetis

10:45
Networking Refreshment Break

11:15
Developing Platform Processes Across Drug Molecules
Tim Hill, Ph.D., Director, Process Development, Fujifilm Diosynth

11:45
Innovation in Harvest/Clarification Unit Operation in Bioprocess Development
Advances in biologics processes have significantly increased product titers, but have also resulted in substantial increases in cell culture densities as well as process/product related impurities. Therefore, corresponding improvements in downstream processing are essential. These downstream improvements should follow a holistic approach, wherein the integrated process and interactions among different unit operations are considered altogether rather than optimizing one unit operation at a time. Recent developments in clarification unit operation in biologics development have resulted in enhancing the performance of Protein A chromatography capture, easing the challenges faced by downstream polishing steps. Implementing new technologies such as multimodal flocculants and AEX hybrid depth filters at the clarification stage can result in process simplification and increased robustness. Residual levels of impurities in the Protein A eluate can be significantly reduced; thus alleviating the burden for further impurities removal in subsequent chromatography steps. The mechanism for removal of process/product related impurities during flocculation and hybrid filtration will also be discussed.
Nripen Singh, Ph.D., Senior Scientist, Biologics Development Organization (BDO), Bristol Myers Squibb

12:15
Networking Luncheon

2:00
New Technologies for Platform Based Development of Antibody Processes
Kumar Dhanasekharan, Ph.D., Director, Process Development, Cook Pharmica LLC

2:30
Novel Technologies for Process Development in Monoclonal Antibody Purification
Glen Giese, Ph.D., Group Leader, Purification Development, Genentech, Inc.

3:00
Networking Refreshment Break

3:30
New Technologies in Bioprocess Development
Pete Gagnon, M.S., Group Manager, Downstream Processing, Bioprocessing Technology Institute, Singapore

4:00
Next Generation Protein A Media for mAb Purification and Development
Alexei Voloshin, Manager, Global Scientific Services Leader, 3M

4:30
Panel Discussion - Opportunities for More Holistic Approach to Biopharmaceutical Purification
Moderator: Abhinav Shukla, Ph.D., Vice President, Process Development & Manufacturing, KBI BioPharma
Panelists:
Chetan Goudar, Ph.D., Director, Pre-Pivotal Drug Substance Process Development, Amgen
Pete Gagnon, M.S., Group Manager, Downstream Processing, Bioprocessing Technology Institute, Singapore
Tim Hill, Ph.D., Director, Process Development, Fujifilm Diosynth

5:00
Close of Symposium

Symposium #4

Future of Biomedicine and Biomanufacturing

1:00 pm – 5:00 pm

From recombinant insulin in 1982 to stem cell therapy for diabetes type 1 in the next decade? The biopharma industry is looking at permanent advancement in science and subsequently new therapeutic modes and molecules with the corresponding processing challenges. This crystal ball view presented by a number of experienced speakers from the industry will exemplify the potential changes in what we may deal with and how we might operate 10-20 years from now.

Presentations will be delivered from Industry Experts focusing on:

  • Future Manufacturing Features and R&D Portfolio Discussion
  • Biomarkers and Future Analytic/Process Control Strategies
  • Facility of the Future
  • Continuous Processing Strategies
  • Closed Processing, Ballroom Concepts, and Single-Use in Future Manufacturing
  • Future Molecules(Including Bispecifics and Designed Molecules) and Cell Therapies Replacing Antibodies

Seminar Leader: Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, BioProcess Division, GE Healthcare Life Sciences, Sweden

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