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 focused topic.

TUESDAY, AUGUST 13 | 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?

TABLE:  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: 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
• characterization
• 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

FRIDAY, AUGUST 16 | 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)