Monday January 17
2:50 Find Your Table and Meet the BuzZ Sessions Moderator
3:00 BuzZ Sessions with Refreshments
BuzZ Table 1: In Silico Antibody Design
- Algorithmic challenges related to modeling antibodies and predicting antibody properties
- Designed diversity versus natural immune combinatorial repertoire
- Experimentalists' wishlist for computational methods
- Challenging targets for which computation tools (may) offer solutions
BuzZ Table 2: Antigens, Antibody Engineering and Specificity
John Williams, PhD, Professor of Molecular Medicine and Co-Director, Drug Discovery and Structural Biology Core, Beckman Research Institute at City of Hope
- Are there unique antigens for oncology?
- How do we find them?
- How can we identify multiple antigens to improve specificity?
- How do we build them?
BuzZ Table 3: Characterization and Control Strategies for Novel Modalities
Kevin Zen, PhD, Executive Director, Chemistry, Manufacturing and Controls, AnaptysBio, Inc.
- MAM as release and stability
- Tools for elucidating structures of LNP and API
- Criteria of biotherapeutic developability
BuzZ Table 4: Application of Artificial Intelligence and Machine Learning
Christian Schoeneich, PhD, Takeru Higuchi Distinguished Professor & Chair, Pharmaceutical Chemistry, University of Kansas Lawrence
- Chemical stability of protein therapeutics
- Physical stability of protein pharmaceutics
- Chemical and physical stability of surfactants
BuzZ Table 5: Cell Therapy Drug Product Development
Bharathi Vellalore, PhD, Scientist, Biotherapeutics Drug Product Development, Janssen
- Process considerations for manufacturing autologous and allogeneic cell therapy products
- Drug product considerations for hematological malignancies and solid tumor indications
- Clinical vs commercial supply chain needs: Integrated drug product design
BuzZ Table 6: Topic to be Announced
Matthew B. Seefeldt, PhD, Executive Director & Research Instructor, Cell Therapy & Manufacturing, University of Colorado
BuzZ Table 7: Common Issues with Transient Protein Production
Richard Altman, Field Application Scientist, Life Science Solutions, Thermo Fisher Scientific
Henry C. Chiou, PhD, Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, PhD, Director, Protein Sciences, Frederick National Laboratory
- What are the current challenges to transient protein production?
- How has the COVID-19 pandemic affected your workflow and productivity?
- How do we optimize the whole protein expression workflow process?
- How can we maintain volumetric yields while scaling transient expression up or down?
- What cell line(s) should we use and when?
- What parameters can impact the quality or physical attributes of transiently produced proteins?
BuzZ Table 8: In Silico Downstream Process Development
Thiemo C Huuk, PhD, Sales Leader, Sales, Cytiva
- Drivers for developing processes in silico
- Smart model selection: statistical, mechanistic, or both?
- Good modeling practices: workflow and best practices
- Modeling opportunities beyond antibody applications
BuzZ Table 9: Future Platforms for Future Modalities
David W. Wood, PhD, Professor, Chemical & Biomolecular Engineering, The Ohio State University
- Are columns here to stay, or is it time to reconsider other approaches?
- What about cleavable tags? Is the risk justified by the need for platforms?
- What kinds of products will be driving this innovation? What do those platforms need to look like in terms of scale, performance and cost?
- How open are companies to trying disruptive technologies? Are the innovations in the products enough for now, so we should play it safe on the methods?
BuzZ Table 10: Automated Cell Culture and Protein Production: Are We There Yet?
Sarah M. Rue, PhD, Associate Director, Advanced Automation Technologies, Genomics Institute of the Novartis Research Foundation
Michelle R. Gaylord, M.S., Senior Scientist II, Genomics Institute of the Novartis Research Foundation
- How well are your automated cell culture needs being addressed by industry partners?
- If you could see one new device or platform become available, what would it be?
- What challenges do you face with automated protein production and/or purification?
- How could these be addressed?
- How do you decide whether a process should be automated or continue to be handled manually?
- How do you handle resistance to implementing automation due to budget concerns, fears about differences in workflow outcomes, etc.?
- Thinking about available automated incubator technologies, what would you love to see changed or added?
Wednesday, January 19
8:00am BuzZ Sessions with Continental Breakfast
BuzZ Table 1: The Making of Bispecific Antibodies
Jonah Rainey, PhD, Vice President, Antibody Engineering, AlivaMab Discovery Services
- Right lead candidate inputs. Can I just use an off-patent sequence?
- Platform selection: geometry, valency, and intellectual property.
- How many candidates need to be made and tested to find a good lead?
BuzZ Table 2: Aggregation in Protein Formulations
Richard Cavicchi, PhD, Research Physicist, Biomolecular Measurement Division, Material Measurement Laboratory, National Institute of Standards and Technology
- What role do formulation components (including polysorbate and silicone oil) play in the aggregate formation and are there strategies to mitigate this process?
- What are the stress factors such as pH changes, temperature changes, or physical effects (shaking/dropping), that are receiving the most attention in your process as a source of aggregates, and what steps are taken to mitigate the stress?
- What measurement instruments are most useful at different stages of product development and maintenance?
- What improvements can help instruments be best utilized for better quantitation and harmonization between instruments?
BuzZ Table 3: Novel Excipients for Sterile Drug Product Formulation
Ankit Kanthe, PhD, Analytical Scientist, Sterile Drug Product Development, Bristol Myers Squibb
- Scope for new excipients in line with FDA’s new initiative
- Understanding excipients ability to prevent protein-protein aggregation
- New experimental tools or computational methods to help screen novel excipients
BuzZ Table 4: Stability Differences of AAV Serotypes
Jared S. Bee, PhD, Director, Formulation & Drug Product Development, REGENXBIO, Inc.
- Do they have different aggregation propensities?
- Is a single formulation suitable for different serotypes?
- Do serotypes have different freeze/thaw stability?
BuzZ Table 5: Cryopreservation Challenges of Biologics, Gene Therapy, and Cell Therapy Modalities
Sanket Patke, PhD, Associate Director, Sanofi
- Impact of temperature on stability and potency of active
- Impact of temperature excursions
- Mitigation strategies to improve cryopreservation
BuzZ Table 6: Multidisciplinary and Inter-institutional Collaborations, How to Succeed?
Bjørn Voldborg, MSc, Head, National Biologics Facility, DTU Bioengineering, Technical University of Denmark
Nathan Lewis, PhD, Associate Professor, Pediatrics and Bioengineering, University of California, San Diego (UCSD)
- How to start-up projects
- Identifying and involving collaborators
- Managing expectations (IP, Funding, commitment, etc..)
- Ensuring efficient and smooth collaboration
BuzZ Table 7: Balancing Speed of Development with the Quality of the Product in the Race to an IND Filing
James Ware, Director Purification Development & Lab Operations, Ligand Pharmaceuticals Inc
- Important factors to consider early in development
- Key considerations for setting the TPP
- Participation on the product team and at what point in the process
- When is titer or process yield “good enough” to move forward?
- Level of focus placed on characterizing process intermediates/impurity clearance
- Sufficient process understanding to ensure tech transfer success
- When to consider manufacturability and cost of goods?
BuzZ Table 8: CMC Strategies for Successful Manufacturing of Drugs and Novel Modalities
Brian O'Mara, Associate Director, Downstream Process Development, Ambrx Inc
- Internal versus external manufacturing
- CDMO selection - Full-service or a la carte - Intermediates (mAb, payload), DS, and DP manufacturing
- CDMO relationships
- Manufacturing of COVID-19 and non-COVID-19 related projects
- Overseas manufacturing and shipment
- Novel modalities and capital investment?
BuzZ Table 9: Why is it so Difficult to Engineer CHO Cells for Improved Expression and Product Quality?
Moderator: Rene Hubert, PhD, Director, Biologics Optimization, Amgen Inc.
Additional co-moderator to be announced
- How do we get the most out of transcriptomics?
- How do we leverage the secretome and surfaceome in generating improved CHO hosts?
- What’s the best way to generate and validate candidate genes?