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

Commonwealth Hall

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

Commonwealth Hall

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

Commonwealth Hall

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

Commonwealth Hall

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

Commonwealth Hall

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

Commonwealth Hall

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

Harborview 1

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

Harborview 3

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

Harborview 2

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

Harborview 2

TABLE 9: Scale-Up of Gene Therapy Products

Moderator: Nathalie Clément, PhD, Associate Director and Associate Professor, Powell Gene Therapy Center, Pediatrics, University of Florida

  • Common challenges in scaling up gene therapies
  • Improving yield, quality and costs
  • Emerging technologies and platforms
  • Improving 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 Biosciences

  • Current DSP technologies
  • Viral Clearance for viral vectors
  • Emerging technologies and platforms


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