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BioProcess International Conference & Exposition - West

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March 14-17, 2016 * Oakland Marriott City Center, Oakland, CA

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Preliminary Agenda of Confirmed Speakers

Preliminary Agenda of Confirmed Speakers

Keynote Address

Amita Goel, Ph.D. Topic TBD
Amita Goel, Ph.D., CEO, Celltheon

Basic Research & Discovery Track

Developability and Early Risk Assessment in Biopharmaceutical Development: Towards a Holistic QbD Implementation
Jesus Zurdo, Lonza R&T

Innovation in Protein Therapeutic Structure Design and Development
Arne Skerra, XL-Protein GmbH, Germany

Novel Manufacturability Assessment of Fc-Fusion Protein Drives Selection of Top Candidate in the Discovery Phase
Jessica Dawson, Ph.D., Group Leader, Analytical Development, Protein and Cell Sciences, EMD Serono Research and Development Institute

Early Stage Process Development & Pre-Clinical Manufacturing Track

Bundling of Cell Line and Vector Technologies to Improve Expression, Stability and Timelines
Thomas Jostock, Ph.D., Senior Fellow, Novartis Leading Scientist, Biologics Technical Development & Manufacturing, Novartis Pharma AG, Switzerland

Expression systems promoter choice and robustness, increasing specific productivity- increasing pressure for the glycosylation machinery, different starter cell lines and robustness of fucosylation, separate tuning of individual glycan species
Volker Sandig, Ph.D., Chief Scientific Officer, ProBioGen AG

Development of Plate-Based Sialic Acid Assays to Support Clone Screening and Early Stage Upstream Process Development
Julie Gardin, Scientist I, Cell Culture Process Development, BioMarin Pharmaceutical, Inc.

Integrated Flocculation Strategy to Streamline Antibody Downstream Processing
Yun (Kenneth) Kang, Ph.D., Principal Scientist, Bioprocess R&D, Eli Lilly & Company

Characterization of the Phosphoproteome to Understand and Improve Bioprocess-Relevant Phenotypes in Recombinant Chinese Hamster Ovary Cells
Paula Meleady, Ph.D., Associate Director, National Institute for Cellular Biotechnology, Dublin City University

Topic TBD
Alison Porter Ph.D., Head of Mammalian Cell Culture R&D, Fujifilm Diosynth Biotechnologies

Single-use, anion exchange chromatography for biopharmaceutical downstream purification using a novel, biomimetic AEX ligand
Jonathan Hester, Ph.D., Senior Technical Specialist, Life Science Process Technology Laboratory, 3M Purification Inc.

Index of Refraction as an Alternative Process Analytical Technology for Downstream Process Monitoring
Jennifer Pancorbo, Ph.D., Assistant Director, Bioprocess Services, Biomanufacturing Training and Education Center, NC State University

Screen and Express Variants of the Lead Molecules to Help in the Selection of the Most Viable Candidates
Kevin McCarthy, EMD Serono

Successfully Applying Quality by Design (QbD) to Vaccine Development
Sabine Gaillard, Ph.D., Scientist, BioProcess Research & Development, Sanofi Pasteur

Employing Design of Experiment Approach In The Optimization Of A Generic Drug Product Formula In Reaction With The Similarity Index Of Dissolution Profile For The Drug Product Innovator
Ahmed Rakha, Ph.D., R&D Section Head, Research and Development, Hochster Pharmaceutical Industries

Upstream Design Space of Host Cell Protein Reagents
Fengqiang Wang, Ph.D., Associate Principal Scientist, Bioprocess Development, Merck & Co. Inc

High Throughput Formulation Strategies for Biotherapeutics
Rajiv Nayar, Ph.D., President, Research and Development, HTD Biosystems Inc

Development of Affordable Biosimilars Based on High Productivity Cultures and Innovative Manufacturing
Julio Baez, Ph.D., Head, Technology Biologics, Technology Management, Cipla Biotech

Analytical Strategy of Charge Variant Analysis for Monoclonal Antibodies
Shao-Chun (Serena) Wang, Ph.D., Associate Principal Scientist, Analytical Method Development, Merck Research Laboratory

Late Stage Process Development & Clinical Manufacturing

Introducing Hydroxyl Radical Footprinting for Higher Order Structure Characterization into the Biotherapeutic Development Workspace
Galahad Deperalta, Scientist, Protein Analytical Chemistry, Genentech

The Single-Use vs Stainless Steel Decision Process - A CDMO Perspective
Peter Rogge, Senior Director USP, Process Science and Production, Rentschler Biotechnologie GmbH

Topic TBD
Paul Wu, Ph.D., Director, Upstream Development, Global Biological Development, Global Biologics, Bayer HealthCare

Advanced Process Control Tools and Strategies for a Platform Process at the 15k Manufacturing Scale
Douglas Osborne, Biogen

Addressing Scale-Up Gaps In Large-Scale Bioreactor Design And Medium Preparation Is Important For Ensuring Successful Transfer To Manufacturing
Henry Lin, Ph.D., Senior Principal Engineer, Cell Culture, Boehringer Ingelheim

BLA Late Stage Acceleration - An Analytical Perspective
Jay Nair, Ph.D., Managing Director, Technical Consultants, Analytical CMC Consulting LLC

Mixing in Millipore Mobius Single-Use Technology
Kenroy Noicely, Senior Scientist, Global Manufacturing Science and Technology, Amgen Inc.

Application of Single-use Centrifugation to Solve Upstream and Downstream Challenges
Sunil Mehta, Ph.D., President and CEO, kSep Systems

Crafting a Robust Validation Strategy to Support Chromatography Resin Storage and Re-Use
James Patch, Ph.D., Principal Engineer, Purification Development, Genentech

End-to-End High Throughput Process Development of a Multimodal Flow-Through Chromatography Operation for a Monoclonal Antibody
Matthew J. Stork, MSc., Scientist, Bioprocess Research & Development, Pfizer

Topic TBD
Sigma S. Mostafa, Ph.D., Vice President, Process Development, KBI Biopharma Inc.

Identification of Dithiohemiacetal (DTHA), A Novel Disulfide Bond Variant, in Therapeutic Monoclonal Antibodies
Patricia Molina, Senior Research Associate, Protein Analytical Chemistry, Genentech, Inc.

Small-Scale and At-Scale Model Development and Optimization
Thomas A. Little, Ph.D., President TLC, Consulting/Training, Thomas A. Little Consulting

Rapid Process Development and Scale-Up for Bioprocesses
Sourav Kundu, Ph.D., Senior Director, R&D Biologics, Teva Pharmaceutical

Topic TBD
Pete Gagnon, M.S., Group Manager, Downstream Processing, Bioprocessing, Technology Institute, Singapore

Impact of Process Parameters on Virus Clearance for Multimodal Anion Exchange Chromatography
Denise Korbe, Senior Research Associate, Purification Development, Process Virology, Genentech, Inc.

A Unique Approach to Limit Aggregates in Final Purified Products
Veronique Bailly, Ph.D., Proncipal Acientist, Bioprocess Development CMC Team Lead, BioProcess Development CMC, Biogen

Commercial Manufacturing

Optimizing Manufacturing Efficiency with New Processes and Technologies
Jason Dempsey, Scientist, Manufacturing Sciences, AbbVie

A Risk Based Approach to Supplier and Raw Material Management
Yuval Shimoni, Ph.D., Principal Engineer, Manufacturing Sciences, Bayer

Building a Process Improvement Strategy for a Legacy Biologics Process Which Enables Implementation of a Next Generation
Amanda Ashcraft, Associate Director, Manufacturing Sciences and Technology, Genzyme

Managing Complex Supply Chain/Supply Chain Strategy
Cathryn Shaw-Reid, Executive Director, Operations Strategic Planning, Global Supply Chain, Amgen

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