Join a breakout discussion group. These are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.
8月13日(二) | 4:45-5:45PM
Optimizing Cell Culture Technology
TABLE: Viral Vector Production - The Grand Challenge of Gene Therapy
Moderator: Lorenz Mayr, PhD, CTO, Life Sciences, GE Healthcare
- Optimisation & scale-up of upstream packaging processes
- Optimisation & scale-up of downstream purification processes
- Miniaturisation & automation of viral vector production
- In-process control and digital tracking of production steps
- QC and product release criteria for viral vectors
TABLE: Glycan Composition Variation during CHO Production Processes
Moderator: Xiaotian Zhong, PhD, Senior Principal Scientist and Lab Head, Pfizer BioTherapeutic Research
- Control of the glycosylation profiles is essential for biopharmaceutical production
- With rising interest in producing therapeutic proteins with distinct N-glycan structures, these issues seem critical
- manipulation of culture conditions (temperature, pH, and feeds)
- glycol-engineering (i.e. generation of knockouts, and expression of glycan remodeling enzymes)
TABLE: Process Intensification Strategies
Moderator: Stefan R. Schmidt, PhD, MBA, COO and Head of Operations, BioAtrium AG
- Compressing process run times
- Continuous processing
- Combining unit operations
- Outsourcing of preparation efforts
TABLE: Monitoring Continuous Culture Processes
Moderator: Michael Butler, PhD, CSO, Cell Technology, National Institute for Bioprocessing Research and Training (NIBRT)
- Are there alternatives to cell sampling?
- Are capacitance measurements a substitute for trypan blue?
- Are automated visual methods sufficiently well developed?
- Are there advantages in detecting an early onset of apoptosis?
Continuous Processing in Biopharm Manufacturing
TABLE: Comparison and Selection Guidance for MCC System in Continuous Downstream Processing
Moderator: Chi-Ming Yu, PhD, Assoc Director, Downstream Purification, Boston Institute of Biotechnology, LLC
- The differences: max columns, max flow rate, price, software, hardware, brand name
- The applications: clinic/commercial, quantity, stability, upstream process
- The one: why, when, how
- The future: the ideal MCC system
TABLE: What You Need to Know About End-to-End Continuous Bioprocessing
Moderator: Robert Dream, Managing Director, HDR Company LLC
- Challenges and opportunities
- Need-based analysis
- Continuous biomanufacturing implementation now and in the future
- Is continuous manufacturing the best solution for your biotech facility?
- Continuous manufacturing as a tool for process intensification
Host Cell Proteins
TABLE: HCP Regulations and Standards
Moderator: Erika Friedl, PhD, Quality Expert, Hematology and Transfusion Medicine, Paul-Ehrlich-Institute
- HCP regulatory expectations throughout development
- Common pitfalls
- Current standards and upcoming developments
- European vs. US expectations
TABLE: Best Practices for HCP Analysis using Mass Spectrometry
Moderators: Ying Zhang, PhD, Principal Scientist, Analytical Research & Development, Pfizer
Veronika Reisinger, PhD, Lab Head, Biologics Technical Development and Manufacturing, Novartis
- Best Practice for Quantitation
- Choice of Instrumentation
- LC/MS for direct lot release
- Digestion Methods Optimization
- Problematic HCPs, Next Gen HCP Analysis
Rapid Methods to Assess Quality & Stability of Biologics
TABLE: Novel CQAs for Novel Formats
Moderator: Elisabeth Kast, PhD, Senior Scientist, Protein Analytics, AbbVie
- When in the discovery/development timeline do you identify non-traditional CQAs
- for a fusion protein or novel modality?
- How do you rapidly implement monitoring during development if no platform
- method is available?
- Does MAM play a role in your strategy for novel formats?
TABLE: Use of Risk-Based Predictive Stability Tools in Regulatory Filings
Moderator: Kara Huang, PhD, Senior Scientist, Drug Product Development, AbbVie
- Types of tools available out there
- Potential pitfalls in using these tools
- Have any of these tools been successfully used in a regulatory filing to justify
- reduced testing?
TABLE: Upcoming Computational Tools in Subvisible Particle Analysis
Moderator: To be Announced
- Availability and applicability of computational tools for routine use in particle
- Machine learning for particle classification
Cell Therapy CMC and Analytics
TABLE: Accelerating Cell Therapy Development
Moderators: Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.
- Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, Former FDA Reviewer
- Most common questions asked by companies/ regulators
- Lessons learnt from recently approved products
- Challenges around gene-edited cell therapies
- Preparing for IND – What are the priorities, preclinical packages?
- CAR Ts in combination with other agents – CMC implications
TABLE: Plasmid Raw Material Control Strategy from Discovery to Commercial
Moderator: Lawrence Thompson, PhD, Principal Scientist, Analytical Research & Development, BioTherapeutics Pharm Sciences, Pfizer
- In Sourcing vs Out Sourcing
- Release Testing & Specifications
- Method Lifetime: Development, Qualification & Validation
- Stability & Period of Use
- Storage Temperature & Container Closure
- Critical Material Attributes & Comparability
TABLE: Commercial Manufacturing of Gene-Modified Cell Therapies: The Challenges Ahead
Moderator: Michael D. Jacobson, PhD, Managing Partner, Cambridge Biostrategy Associates
- What are the most important problems that need to be solved over the next 3-5 years for this industry to thrive?
- What key innovations would you like to see that you believe would be transformative?
- How low do COGS need to go, and how (and when) will we get there?
- How automated and integrated will cell therapy manufacturing become over the next 5-10 years? What parts of the workflow are most ripe for integration, and which are not?
Process Characterization and Control
TABLE: Could Artificial Intelligence and Machine Learning Accelerate Drug Development? How and What is Needed?
Moderator: Wolfgang Paul, PhD, Principal Scientist and Digitalization Lead, Large Molecule Research, Roche, Germany
8月16日(五) | 7:30-8:20AM
Optimizing Cell Line Development
TABLE: Industry/Academic Collaboration
Moderator: Hooman Hefzi, PhD, Postdoctoral Researcher, Pediatrics, UC San Diego (UCSD)
- What makes a good collaboration?
- What are the largest barriers to collaboration?
- Are there alternatives to traditional collaborative setups?
TABLE: What a Stability Study Package Should Consist of for STABLE Producer Cell Lines
Moderator: Aubrey R. Tiernan, PhD, Senior Scientist I and Head, Cell Line Development, Ultragenyx Gene Therapy
- What affects stability?
- What does a stability study package look like?
- How can we use genome stability information to generate more stable cell lines?
- What are some strategies to evaluate long term stability?
- What new technologies can we use to predict clone stability?
Detection, Characterization and Control of Impurities in Biologics
TABLE: Challenges in Antibody Production
Moderator: Michael Anyadiegwu, PhD, Senior Scientist, Downstream Processing, Centre for Process Innovation Ltd., National Biologics Manufacturing Centre
- Streamlining processes for the purification on antibodies and new medicines
- New tools and methods
TABLE: Accelerated Development and Risk Management for Unmet Medical Needs and Breakthrough Therapies
Moderator: Douglas E. Kiehl, MSc, Research Advisor, Bioproduct, Research & Development, Eli Lily and Company
- Accelerated development of pharmaceuticals for unanticipated/unmet medical needs
- Accelerated regulatory review/approval processes for unmet medical needs and breakthrough therapies
- New technologies for detection of pathogens and impurities, also in-vitro and companion diagnostics
Process Characterization and Control
TABLE: Analytical Challenges in Cell Therapy
Moderator: Sheila G. Magil, PhD, Managing Director, Industry Specialized Services, BDO
TABLE: Challenges and Opportunities during Implementation of New Analytical Technologies
Moderator: Elena Smith, PhD, Deputy Director, Quality Control, Sanofi Pasteur
- Alternative standards
- Alternative methods
- Challenges for the analytical characterization for the new technologies
TABLE: Analytical Comparability for Innovator Products - How Much is Enough?
Moderator: Sonia Taktak, PhD, Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
- How should one design a comparability study in early/late stage development vs. commercial?
- What stability/stress conditions do you include in your comparability studies?
- Should one use statistics for assessing comparability/evaluating rates or routes of degradation?
- What analytical characterization methods do you include in your comparability studies?
Gene Therapy Manufacturing
TABLE: Scale-Up of Gene Therapy Products
Moderator: Johannes C.M. van der Loo, PhD, Director, Clinical Vector Core, The Raymond G. Perelman Center for Molecular and Cellular Therapies, Children’s Hospital of Philadelphia
TABLE: Purification of Viral Vectors
Moderator: Alois Jungbauer, PhD, Professor, Institute of Biotechnology, University of Natural Resources and Life Sciences (BOKU)