Breakout Discussion Groups

Engage in in-depth discussions with industry experts and your peers about the progress, trends, and challenges you face in your research! 

Interactive discussion groups play an integral role in networking with potential collaborators. They provide an opportunity to share examples from your work, vet ideas with peers, and be part of a group problem-solving endeavor.

These will take place IN-PERSON ONLY.

Tuesday, August 15: 10:45 – 11:30 AM

Cell Line Development & Cell Culture Optimization

TABLE 1: The Indispensability of Gene Editing in Drug Discovery and Development
Moderator: Metewo S. Enuameh, PhD, Senior Scientist, Vector Core Cell Line Development, REGENXBIO, Inc.

• How relevant are isogenic cell lines in drug discovery and development today? 
• What are the factors to consider in choosing a cell line for isogenic cell line development? 
• What are some strategies to evaluate long term stability of clones?  
• What new technologies can we employ to predict clone stability?

Intensified & Continuous Processing

TABLE 3: Bioreactor Design and Optimization for Continuous Bioprocessing
Moderator: Jean-Francois P. Hamel, PhD, Lecturer, Chemical Engineering, Massachusetts Institute of Technology

• Assessing microbial and animal cell benchtop bioreactors, designed for fed batch or continuous applications (eg: perfusion) and scale-down studies
• Choosing microfluidics and benchtop bioreactors (traditional and single use) for screening, optimization and process development.

TABLE 4: Transient Expression vs Stable (Pool) Cell Lines
Moderator: Stefan Schmidt, PhD, MBA, CEO, evitria AG

• When to choose what mammalian expression system?
• Effort, expression level, timelines, typical purposes, cost, scale, quality, development lifecycle
• Pros and cons for the different approaches

Gene Therapy CMC and Analytics

TABLE 5: Formulation, Stability, Delivery, and Forced Degradation Studies
Moderator: Kruti Soni, PhD, Scientist, Technical Development, Biogen

• Formulation
• Stability for Gene Therapies
• Forced Degradation
• Device Selection

Cell Therapy CMC and Analytics

TABLE 6: Trends in CMC for Cell Therapies
Moderator: Scott R. Burger, Principal, Advanced Cell & Gene Therapy LLC

• Trends in CMC
• Tech transfer
• Manufacturing

TABLE 7: Potency Assays for Cell Therapies
Moderator: Rian de Laat, PhD, Associate Director, CMC, Voisin Consulting Life Sciences

• Importance of the cell therapy potency assay
• Potency assay development challenges
• Bridging the gap between R&D and Manufacturing
• The evolving regulatory landscape of potency assays

Host Cell Proteins

TABLE 8: Use of LC-MS as a Release Method for HCP
Moderator: Thomas Kofoed, PhD, Co-Founder & CEO, Alphalyse, Denmark

• Why is there a need for LC-MS as a release method? What types of products/biologics would it be particularly relevant for?
• What are the major challenges using LC-MS as release test? And how could these be overcome?
• What will the new USP chapter and USP standards for HCP Analysis by Mass Spectrometry lead to?
• What are relevant product release specifications CoA – total HCP amount?, individual amount of problematic HCP?, Amount of Top20 HCPs?
• Should animal ethics be a concern? Would you choose LCMS instead of ELISA that requires immunization and use of experimental animals?
  

TABLE 9: HCP Detection, Analysis and Control
Moderator: Rosalind L. Ang, PhD, Associate Principal Scientist, Merck 

• Comparing a platform assay against a second assay (e.g., commercial kit) for relevance and prospective uses
• Strategies for transitioning from a commercial kit to process-specific or platform assay (antibody coverage, bridging, phase appropriateness) 
• Immunoassays for commercial phase DS manufacturing
• ELISA test results for individual HCPs on DS release specs

Rapid Methods to Assess Stabilities and Impurities in Biologics

TABLE 10: Host cell proteins (HCPs): Challenges and Opportunities
Moderator: Sunny Zhou, PhD, Professor, Chemistry & Chemical Biology, Northeastern University

• High-risk host cell proteins (HCPs): what and why
• Characterization: challenges and opportunities
• Removal (purification): challenges and opportunities

Vaccine Development and Manufacturing

TABLE 11: Formulation Development, Bioprocessing, and Manufacturing of Vaccines
Moderator: Christopher P. Locher, PhD, Co-Founder & CEO, Biology, Versatope Therapeutics

• Continuous manufacturing
• Reducing costs for mRNA synthesis 
• Formulations for thermostability 

Thursday August 16 9:30 – 10:30 AM

Smart Biomanufacturing & Digitalization

TABLE 12: Modeling Liquid-Liquid Mixing in Drug Product Process Development
Moderator: Robert Kuo, PhD, Assoc Principal Scientist, Sterile & Specialty Products, Merck

• Critical inputs for creating a representative model
• Extracting actionable data and insights from simulations
• Validating results and impacting the process development outcome

TABLE 13: Steps Towards A Fully Automated Bioprocess
Moderator: Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences (BOKU)

• Process integration a prerequisite for automation
• What are the barriers for full automation?
• Which sensors do we need?
• Benefits of automation

Cell Therapy Manufacturing

TABLE 14: Manufacturing Cell and Gene Therapies
Moderator: Michael D. Jacobson, PhD, Managing Partner, Cambridge Biostrategy Associates LLC

• Trends in commercializing cell and gene therapies
• De-centralized versus centralized manufacturing
• Pricing trends, reducing costs
• New trends
• in vivo CAR T engineering and delivery
  

Accelerating Analytical Development

TABLE 15: Accelerating Analytical Development of Novel Modalities: Challenges & Potential Solutions
Moderator: Xue (Shelly) Li, Associate Director, Biologics Development, Bristol Myers Squibb

• Major challenges in CQA evaluation for novel modalities (e.g., AAV, FDC, Alternative-Format Molecules)
• Limitations of conventional analytical tools for the analysis of novel modalities
• Pros and Cons of new analytical technologies in the development of novel modalities
• Health Authority’s perspective ― Is it possible to achieve both high speed and high quality?

TABLE 16: Technological Innovations to Accelerate Analytical Development
Moderator: Zhirui (Jerry) Lian, PhD, Senior Director, Eli Lilly and Company

• Opportunities and challenges of high-resolution and high-throughput analytical methods (e.g., MAM, NMR etc.)
• Automation: successful stories and lessons learned
• Digital transformation: successful stories and lessons learned.
• Future perspective of Machine learning/Artificial Intelligence in biotherapeutics development

Formulation and Delivery of High-Concentration Proteins and New Modalities

TABLE 17: Formulation and Stability Considerations Delivery for Proteins and New Modalities
Moderator: Christopher P. Locher, PhD, Co-Founder & CEO, Biology, Versatope Therapeutics

• Polypeptide composition and glycosylation profiles
• Lyophilization, gelatin, simple sugars and amino acids as excipients and Ionic and zwitterionic buffers and pH to support solubility and reconstitution
• Silanized glass vials and drug/product silicone interactions

mRNA-Based Therapies

TABLE 18: dsRNA in LNP-mRNA Vaccine Products
Moderator: Christina Schier, PhD, Senior Scientist, Merck & Co., Inc.

• How do we measure dsRNA? – Current analytical methods.
• What are the biological implications for dsRNA in vaccines? 
• What might the non-emergency dsRNA regulatory landscape look like?