Round Table Discussions
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
TUESDAY, AUGUST 13 | 4:45-5:45PM
Optimizing Cell Culture Technology
TABLE 1: 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 2: 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 3: 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 4: 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?
TABLE 5: Omics and Big Data
Moderator: Jamey Young, PhD, Associate Professor, Chemical and Biomolecular Engineering, Vanderbilt University, and Co-Founder and Chief Scientific Officer, Metalytics LLC
- Which technologies have been most useful for specific applications?
o Process development
o Media development
o Cell line development
o Biosimilars development
o Regulatory compliance
- What are your major success stories with use of omics and big data?
- What are the important limitations and challenges to consider?
- What are the emerging trends and latest developments in this space?
Continuous Processing in Biopharm Manufacturing
TABLE 6: Comparison and Selection Guidance for MCC System in Continuous Downstream Processing
Moderator: Louise Taylor, BSc., Downstream Scientist, Biologics, Centre for Process Innovation
- 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 7: 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 8: HCP for Gene Therapies
Moderator: Emily Menesale, Senior Associate Scientist, Analytical Development, Biogen
- What are some logistical challenges in running HCP assays for gene therapy products as opposed to other types of drugs?
- What are some challenges in using non-traditional host cell lines? What cell lines are people using and what are their strategies?
- Are commercial HCP kits ok for non-traditional host cell lines or are custom HCP assays needed?
- Have people observed any problematic viral antigens?
TABLE 9: Best Practices in HCP Immunoassay Development and Qualification
Moderators: Eric Bishop, Vice President, R&D, Cygnus Technologies
- Common misconceptions and mistakes in developing HCP assays
- What Orthogonal Methods to use to demonstrate an HCP assay fit for purpose?
- Generic vs Process-specific HCP Assays
Rapid Methods to Assess Quality & Stability of Biologics
TABLE 10: 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 11: Use of Risk-Based Predictive Stability Tools in Regulatory Filings
Moderator: Kara Huang, PhD, Senior Scientist, Drug Product Development, AbbVie
- Types of tools available
- Potential pitfalls in using these tools
- Have any of these tools been successfully used in a regulatory filing to justify reduced testing?
TABLE 12: Protein Aggregation in Novel Biologics
Moderator: Subhashchandra Naik, PhD, Senior Scientist, Reform Biologics
- Importance of mechanistic understanding of protein degradation and aggregation pathways
- Predictive tools and characterization methods
- Impact of aggregation on product development timelines
Cell Therapy CMC and Analytics
TABLE 13: Accelerating Cell Therapy Development
Moderators: Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.
- 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 14: 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 15: Allogeneic vs Autologous
Moderator: Michael D. Jacobson, PhD, Managing Partner, Cambridge Biostrategy Associates
- How to manage scientific, technical and clinical risks?
- Manufacturers: choosing between allogeneic and autologous; or can you do it all?
- Suppliers: how to invest in an uncertain future?
- What is the roadmap for combining autologous and allogeneic approaches? Will allogeneic eventually replace, or complement autologous?
- New technologies (iPS, NK cell, etc.) - how will these impact current CAR-T and TCR approaches?
Process Characterization and Control
TABLE 16: 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
- AI in Drug design and development - what does this mean? Hype or reality?
- Prediction in protein design & development - expectations
- Is acceleration possible or is AI more an enabler?
- Critical prerequisites to enable machine learning and prediction in drug design and development
- Benefits measurable and which KPI's have to be addressed?
FRIDAY, AUGUST 16 | 7:30-8:20AM
Optimizing Cell Line Development
TABLE 1: 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 2: 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?
TABLE 3: Cancelled
Detection, Characterization and Control of Impurities in Biologics
TABLE 4: 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 5: 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 6: Analytical Challenges in Cell Therapy
Moderator: Sheila G. Magil, PhD, Managing Director, Industry Specialized Services, BDO
- Using OOS materials for patients
- What release assays are needed for cell therapy products?
- Quality and testing of raw materials used for manufacture of cell therapy
- What does purity mean for a cell therapy product?
TABLE 7: 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 8: 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 9: Scale-Up of Gene Therapy Products
Moderator: Nathalie Clément, PhD, Associate Director and Associate Professor, Powell Gene Therapy Center, Pediatrics, University of FloridaCommon challenges in scaling up gene therapiesImproving yield, quality and costsEmerging technologies and platformsImproving yield, quality and costs
TABLE 10: Purification of Viral Vectors
Moderator: Alois Jungbauer, PhD, Professor, Institute of Biotechnology, University of Natural Resources and Life Sciences (BOKU), Matthew Roach, PhD, Process Development Engineer, Precision BiosciencesCurrent DSP technologiesViral Clearance for viral vectorsEmerging technologies and platforms