Interesting Talks in Each Track. Here are some examples:

Keynote Presentations

Engineering Novel Proteins and Protein Assemblies as Innovative Therapeutics, Vaccines, and Drug Delivery Vehicles James R. Swartz, Ph.D., James H. Clark Professor, School of Engineering, and Professor of Chemical Engineering and of Bioengineering, Stanford University Challenges and Opportunities in Pharmaceutical Development Dana C. Andersen, Ph.D., Senior Director, Pharmaceutical Development, U.S. Biologics Technical Development, Genentech – a Member of the Roche Group Manufacturing in a Global Market Place TH Kim, Ph.D., President and CEO, Samsung BioLogics Innovation in Biologics Manufacturing Hitto Kaufmann, Ph.D., Vice President, Technology and Innovation, Sanofi Biologics, Germany

Upstream Processing

Efficient Bioprocess Monitoring Strategies Using Cedex Bio HT in the Development of Reliable and High Quality Biomanufacturing Processes Tim Hill, Ph.D., Director, Upstream Process Development, Fujifilm Diosynth High Octane Fed Batch: Process Intensification Reimagined Rebecca Moore, Ph.D., Senior Scientific, BioProduction, Thermo Fisher Scientific Evolution of Cell Culture Validation Studies as a Result of Lessons Learned from Implementing Quality by Design Steve Meier, Ph.D., Principal Engineer and Senior Group Leader, Genentech

Antibody Drug Conjugate Development and Production

Development of a Site-Specific Conjugation Process Applicable to Monoclonal and Bispecific Antibodies Ellen O’Connor, Ph.D., Senior Scientist, MedImmune Clinical Development of ADCs – How are We Doing? Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc.

Single-use Applications

A Point of Use Method for Leak Prevention in Single-Use Process Containers Adam Sokolnicki, Biomanufacturing Engineer, EMD Millipore Single-Use Fermentation – Performance and Evaluation Surendra Balekei, Senior Product Manager, Single-Use Reactors and Mixers, Thermo Fisher Scientific Integrating a Fully-Disposable Centrifuge a Completely Disposable Facility (200L Scale) Brad Ebel, Manager, LSDL, Shire

Downstream Processing

Overcoming Reduction of Antibodies in Harvest Step Michael Laird, Senior Scientist, Associate Director, Process Development, Genentech, Inc. Integrated and Fully Continuous Processing of Recombinant Therapeutic Proteins – From Cell Culture Media to Purified Drug Substance Veena Warikoo, Ph.D., Director, Purification Development, Genzyme

Manufacturing Efficiencies: Strategy and Technology

The Potential Impact of Biosimilars on Biomanufacturing Capacity Thomas C. Ransohoff, Vice President & Principal Consultant, BioProcess Technology Consultants, Inc. Supplier Management Best Practices Patricia Turney, MBA, Executive Director, Medical Device & GMP Materials Supply Chain, Amgen

Flexible Facilities

Flexible and Multiproduct Facility: Single Use Technologies & Biocontainment Strategy Jin Wang, Ph.D., Director, VDL2 Launch Manufacturing Facility, Industrial Operations, Sanofi Pasteur Processes of the Future: Single Use, Closed and Continuous for Faster, Cheaper and Safer Manufacturing Sebastien Ribault, Ph.D., Director Biotechnology/Life Science, Head of BioDevelopment Center, EMD Millipore Single-Use Bioreactors for Commercial Production of Antibodies Matt Croughan, Ph.D., Industry Professor and Founder of Bioprocessing Program, Amgen Bioprocessing Center at Keck Graduate Institute

Analytical Methods and Technologies

Real-Time Monitoring of ADC Conjugation Process Ian Schwartz, M.S., Senior Engineering, ADC Process Development, Agensys, an affiliate of Astellas Successfully Applying QbD Concepts to Develop a Robust Lyophilized Protein Therapeutic Product Kevin Zen, Ph.D., Senior Manager, Biologics Development, Allergan

Quality and Control

Best Practices for Bringing Legacy Products up to Current Process Validation Articless Monica Lent, Head of Process Validation and Knowledge, Genentech Paradigm for Process Validation of Biopharmaceuticals Kim H. Wong, Ph.D., Director, Facilities & cGMP Support, BioProcess Research & Development, Sanofi Pasteur Ltd.

Cell Culture Dish Sponsor Activities:

GE Healthcare Life Sciences – Booth 122

Technology Workshops:

Monday, March 30, 12:05 – Single-use Fermentation: Understanding Process Economy and Process Performance Ken Clapp, Product Manager, Bioreactors, GE Healthcare Wednesday, April 1, 12:05 – Downstream Processing and New Technology for Continuous Chromatography Maria Ekblom, Senior Project Manager, Chromatography Systems, GE Healthcare Wednesday, April 1, 12:05 – How to Rapidly Enable Flexible Biomanufacturing at the Site of Your Choice Vikas Gupta, Modality Leader, Bioprocess Solutions, GE Healthcare Life Sciences

Life Technologies/Thermo Scientific – Booth 103

Tuesday, March 31, 9:15 – Single-Use Fermentation – Performance and Evaluation Surendra Balekei, Senior Product Manager, Single-Use Reactors and Mixers, Thermo Fisher Scientific Tuesday, March 31, 2:15 – High Octane Fed Batch: Process Intensification Reimagined Rebecca Moore, Ph.D., Senior Scientific, BioProduction, Thermo Fisher Scientific Technology Workshop: Wednesday, April 1, 12:05 – Capture Chromatography: Alternatives for Downstream Process Development Shelly Parra, M.S., Sr. Field Application Scientist, Thermo Fisher Scientific

Roche Custom Biotech – Booth 203

Featured Products:

• Cedex Bio and Bio HT Analyzers: Accurate and reliable metabolite and substrate analysis
• Cedex HiRes Analyzer: high-resolution automated cell counter based on Trypan Blue technology
• MycoTOOL PCR Mycoplasma testing kits: in-process and product release quality assurance
• Glycoengineering portfolio: complete tool kit for glycosylation and analytics consisting of activated sugars, transferases and glycosidases
• Recombinant Trypsin, GMP Grade: increased process safety in polypeptide production

EMD Millipore – Booth 319

Monday, March 30, 11:00 -A Point of Use Method for Leak Prevention in Single-Use Process Containers Adam Sokolnicki, Biomanufacturing Engineer, EMD Millipore Wednesday, April 1, 1:45 – Processes of the Future: Single Use, Closed and Continuous for Faster, Cheaper and Safer Manufacturing Sebastien Ribault, Ph.D., Director Biotechnology/Life Science, Head of BioDevelopment Center, EMD Millipore

PALL Life Sciences – Booth 313