BPI West 2016 begins March 14th in Oakland. The conference is focused on providing companies the opportunity to share ideas, strategies and solutions to overcome challenges at every stage of development. Cell Culture Dish will be attending and blogging from the event. Please don’t miss our BPI West related blogs over the next month.

If you are attending, don’t miss these exciting talks and activities!

Interesting Talks in Each Track. Here are some examples:

Keynote Presentations

Innovative Technologies for the Expression of Next Generation Bio Therapeutics
Amita Goel, MSc., Founder and CEO, Celltheon

Adapting Process Development capabilities for a Modality Independent Strategy
Rohini Deshpande, Ph.D., Executive Director, Process and Product Development, Amgen, Inc. (co-authored by Alison Moore, Ph.D., Senior Vice President, Process Development, Amgen, Inc.)

Unleashing the Power of Innovation to Tackle Biomanufacturing’s GreatestChallenges, Fuel Growth and Drive Value Creation
Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen Inc.

Pre-conference Symposia

Innovative Approaches and Technologies in Process Development and Manufacturing

Hollow Fiber Bioreactors: Single-Use. Perfusion. Scalable. Continuous Manufacturing.
Scott Waniger, VP BioServices Division, Cell Culture Company

Elevated Productivity Options for Continuous Capture without Protein A
Pete Gagnon, M.S., Group Manager, Downstream Processing, Bioprocessing, Technology Institute, Singapore

Building the plane while flying it: Scaling autologous Cell Therapy
Phil Vanek, General Manager Cell Bioprocessing, GE Healthcare

The Future of Continuous Processing

Risk Mitigation in Continuous Downstream Manufacturing – Using ‘Smart’ Single Use Flow Paths, Strategies for Dynamic Switching, Automation and Multi-Variant Data Analysis to Support Continuous Downstream Processes
Marc Bisschops, Ph.D., Principal Scientist, Continuous Processing, Pall Life Sciences

Integrated Continuous Automated Bioprocessing
William N. Napoli, Scientist, BioProcess Technology and Expression, BioProcess Development, Merck & Co., Inc.

What is Holding the Industry Back from Implementing a Continuous mAb Bioprocess?
Frank Nygaard, Ph.D., Global Technology Partner, Global Best Practice, NNE Pharmaplan, Denmark

Basic Research & Discovery

Hacking the Endoplasmic Reticulum into a Test Tube to Identify mAb Clones that Show Expression and Formulation Problems Before They Happen: Implications to Lead Selection, Optimization, and Engineering Strategy
Haruki Hasegawa, Ph.D., Principal Scientist, Therapeutic Discovery, Biologics, Amgen Inc.

Thinking Ahead: Hit Optimization Using In Silico, Functional and Analytical Tools inEarly Discovery for Better Lead Molecules in Late Discovery
Vanita D. Sood, Ph.D., Head, Protein Design, Optimization & Characterization, Protein Engineering and Antibody Technologies, EMD Serono Research Institute

Developability and Early Risk Assessment in Biopharmaceutical Development: Towards a Holistic QbD Implementation
Jesus Zurdo, Ph.D., Senior Director Strategic Innovation, Lonza, United Kingdom

Early Stage Process Development & Pre-Clinical Manufacturing

Identifying Key Drivers of Variability within Cell Culture Media
Jon C. Wannlund, Ph.D., Director, Research & Development, BD Biosciences

Understanding Trace Metal Variability in Cell Culture Medium Components
Chandana Sharma, Ph.D., Principal Scientist, Cell Sciences and Development, MilliporeSigma

Use of a New Analytical Method (Cedex Bio/Bio HT): Revolutionizing E. coli Fermentation In-Process Monitoring
Geeta Singh, Pilot Plant Tech Specialist III, Genentech Inc.

Late Stage Process Development & Pre-Clinical Manufacturing

Be In or Be Out: Continuous Processing of Biopharmaceutical Proteins
Gunter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, BioProcess Division, GE Healthcare Life Sciences, Sweden

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

Finding Synergy: Co-location with Commercial Manufacturing for Process Development
Paul Wu, Ph.D., Director of Upstream Development, Global Biological Development, Global Biologics, Bayer Pharmaceuticals

Commercial Manufacturing & Beyond

Planning for Tomorrow: Building a Process Improvement Strategy for a Legacy Biologic Process
Amanda B. Ashcraft, MSEM, Associate Director, Purification and Analytical Operations, Manufacturing Sciences and Technology, Genzyme, a Sanofi Company

Managing Life Cycle of a Break Through Therapy Designated Product
Gargi Maheshwari, Ph.D., Executive Director, Biologics Process Development & Commercialization, Merck & Co.

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

Technology Workshops:

Tuesday

In the Quest for an Optimized Upstream Bioprocess – Are We There Yet?
Nan Lin, Cell Culture Process Applications Leader, GE Healthcare

Factors to Consider for Selection of an Auto-Sampling Technology and Process Management Systems with Roche Cedex Analyzers: Flownamics and Bend Solution, links in Bioprocess Automation with Cedex Analyzers
Clint Pepper Ph.D., Director, Bend Research
Ashely Fisher Kapp, Product Manager, Flownamics

Development of Early Stage Therapeutic Antibody Candidates
David T. Ho Ph.D., Senior Scientist II, Irvine Scientific
Yves Durocher Ph.D., Research Officer, National Research Council Canada

Wednesday

Evolving Current mAb Purification Platforms: How the Sum of Small Changes Can Lead to Big Steps Forward in mAb Production
Peggy Lio, Global Cell Culture Science Leader, GE Healthcare

Technical Considerations in Developing a New Plastic Film for Single Use Technologies
Susan Burke, Ph.D., Material Science Leader, GE Healthcare

Rapid, Scalable Production of Recombinant Proteins via Transient Transfection for Therapeutic Development
Brian Pescatore, Scientist, Protein/Antibody Engineering , Discovery Therapeutics, Shire

Thursday

Faster to Market: Case Studies on Successful Technical Transfer, Manufacturing and Support Utilizing Single-Use Systems and Flexible and Deployable Manufacturing Platforms
Joe Makowiecki, Global Technical Manager, GE Healthcare Life Sciences

Cell Culture Dish Sponsor Activities:

BD Biosciences – Booth 513

Featured Product:

Introducing and taking sample requests for their newest medium and feed design specifically for CHO.- www.bdbiosciences.com/go/cho-cd

Talk:

Wednesday March 16th, 8:05 AM
Identifying Key Drivers of Variability within Cell Culture Media
Jon C. Wannlund, Ph.D., Director, Research & Development, BD Biosciences

Cell Culture Company– Booth 505

Talk:

Hollow Fiber Bioreactors: Single-Use. Perfusion. Scalable. Continuous Manufacturing.
Scott Waniger, VP BioServices Division, Cell Culture Company

Featured Product:

GMP Manufactured Proteins On Demand

• Custom GMP contract production in mg to kg quantities
• Biologically active proteins and various cell types
• Pre-clinical to commercial
• Mammalian and insect cell-based expression systems
• Single-use perfusion bioreactor and traditional cell culture platforms
• Serving 1,700+ labs globally
• Production of 2,650+ cell lines
• Guaranteed price-per-gram, on-demand delivery, and secure supply
• Manufacturer of FDA approved theraputics

Charter Medical – Booth 208

Featured Product:

Freeze-Pak™ Bio-Containers with FP-FLEX™ Tubing for working cell bank applications
Cold chain tubing and containers designed for cryogenic storage and transport applications enabling closed-system continuous processing.

• Tubing and containers tested and validated to -196°C
• FP-FLEX™ tubing compatible with C-Flex®
• Closed-system aseptic transfer via tube-to-tube connection
• Compatible with standard tube welding and sealing devices
• Compatible with industry available freezing/storage cassettes
• Reduces handling and seed train expansion steps

GE Healthcare Life Sciences – Booth 102

Talks:

Pre-Conference Symposia:

Building the plane while flying it: Scaling autologous Cell Therapy
Phil Vanek, General Manager Cell Bioprocessing, GE Healthcare
Monday, March 14, 12:05 pm

Late Stage Process Development:

Be in or be out: Continuous process of biopharmaceutical proteins
Dr. Günter Jagschies, Senior Director Strategic Customer Relations, GE Healthcare
Wednesday, March 16, 11 am

Fireside Chat:

Bringing it all together for commercialization: Perspectives from every stage
Dr. Günter Jagschies, Senior Director Strategic Customer Relations GE Healthcare
Thursday, March 17, 8:30 AM

Technology Workshops:

In the quest for an optimized upstream bioprocess—are we there yet?
Tuesday, March 15, 11:50 am

Evolving current MAb purification platforms: how the sum of small changes can lead to big steps forward in MAb production
Wednesday, March 16, 7:25 am Free continental breakfast

Technical considerations in developing a new plastic film for single-use technologies
Wednesday, March 16, 12:05 pm

Faster market access through parallelization of facility construction and process development
Thursday, March 17, 12:05 pm

Posters:

• Custom media: streamlining the complexities. Johnson et al.et al.
• The use of dynamic control in periodic counter-current chromatography. Hall et al.
• Mixing dynamics in a large-volume single use mixer: effect of tank shape and impeller quantity on salt settling and dispersion. Sampath et al.

Ask the Expert:

Who: Joe Makowiecki, Global Technical Manager
When: Tuesday 5–6 pm | Wednesday 9:45-10:30 am and 3:15–4 pm
Where: GE Booth #102

For more information, please see – promo.gelifesciences.com/gl/K16013/home.html

EMD Millipore

Talk:

Early Process Development
Wednesday March 16th, 8:30AM

Understanding Trace Metal Variability in Cell Culture Medium Components
Chandana Sharma, Ph.D., Principal Scientist, Cell Sciences and Development, MilliporeSigma

Essential Pharmaceuticals – Booth 117

Featured Products:

• Cell-Ess cell culture supplement increases protein yield in previously optimized cell-media systems without altering glycosylation or metabolite profile. Chemically defined, animal component free.
• New data on the use of Cell-Ess to address many bioproduction challenges including the following: protein productivity, scalability, glycosylation, cell metabolism and downstream purification.

PALL Life Sciences – Booth 715

Pre-Conference Symposia: The Future of Continuous Processing

1:00 pm:
Chairperson’s Remarks – How to Deal With Resistance to Change in Your Organization: Lessons from Industry Professionals Trying to Enact Change
Lynne Frick, Director of Sales, Continuous Bioprocessing, Pall Corporation

1:15 pm:
Update on Significant Technology Advances Enabling Integrated Continuous BioProcessing
Michael Egholm, Ph.D., President, Biopharmaceuticals, Pall Corporation

2.30 pm:
Risk Mitigation in Continuous Downstream Manufacturing – Using ‘Smart’ Single Use Flow Paths, Strategies for Dynamic Switching, Automation and Multi-Variant Data Analysis to Support Continuous Downstream Processes
Marc Bisschops, Ph.D., Principal Scientist, Continuous Processing, Pall Life Sciences

4:30 pm:
Moderated Open Discussion
Marc Bisschops

Talks:

Thursday, March 17
Fireside Chat: Early Stage Process Development & Pre-Clinical Manufacturing

10:25 am:
Chairperson’s Remarks
Lynne Frick, Director of Sales, Continuous Bioprocessing, Pall Corporation

10:30 am – 12:00 pm:
Continuous Bioprocessing: What is Your Company’s Choice? Perfusion or Intensified Fed Batch Paired with Continuous Downstream?

To learn more – pall.com/main/about-us/event-details.page?id=20151009051602

Roche Custom Biotech – Booth 701

Talks:

Wednesday March 16th 9:20
Early Process Development Use of a New Analytical Method (Cedex Bio/Bio HT): Revolutionizing E. coli Fermentation In-Process Monitoring
Geeta Singh, Pilot Plant Tech Specialist III, Genentech Inc.

Luncheon Technology Workshop:

Tuesday, March 15th, 12:20 p.m.
Technology Workshop: Factors to Consider for Selection of an Auto-Sampling Technology and Process Management Systems with Roche Cedex Analyzers: Flownamics and Bend Solution, links in Bioprocess Automation with Cedex Analyzers
Clint Pepper Ph.D., Director, Bend Research
Ashely Fisher Kapp, Product Manager, Flownamics

Products and capabilities that will be showcased:

• In vitro glycoengineering portfolio·
• mRNA production portfolio
• Cedex HiRes automated cell counter
• Cedex Bio and Bio HT nutrient/metabolite analyzers
• Proteases portfolio
• Quality control testing kits

For more information, please see – cellculturedish.com/wp-content/uploads/sites/2/2020/05/Roche-Custom-Biotech_2016-BPI-West-Flyer.pdf