BUZZ Sessions


FACILITATED, SMALL-GROUP DISCUSSIONS. INTERACTIVE PARTICIPATION LEADS TO PROBLEM-SOLVING SOLUTIONS AND FUTURE COLLABORATIONS AROUND FOCUSED TOPICS.

What’s the BuzZ about?

PepTalk’s BuzZ Sessions are focused, stimulating discussions in which delegates discuss important and interesting topics related to upstream protein expression and production through downstream scale-up and manufacturing. This is a moderated discussion with brainstorming and interactive problem-solving between scientists from diverse areas who share a common interest in the discussion topic.

These are forums for open discussion of protein-related challenges, and not sales opportunities. We emphasize that these breakout groups are for interactive discussions among scientists and are not meant to be, in any way, a corporate or product discussion. Topics can be limited to one protein area or may address issues which cross over the borders between pipeline conference topics. Moderators should be well-versed in the topic area and able to keep the discussion focused and productive.

Monday January 17

2:50 Find Your Table and Meet the BuzZ Sessions Moderator

3:00 BuzZ Sessions with Refreshments

In Silico Antibody Design

Possu Huang, PhD, Assistant Professor, Bioengineering, Stanford University

  • 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

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?​

Characterization and Control Strategies for Novel Modalities

Kevin Zen, PhD, Executive Director, Chemistry, Manufacturing and Controls, AnaptysBio, Inc.

Topic to be Announced

Christian Schoeneich, PhD, Takeru Higuchi Distinguished Professor & Chair, Pharmaceutical Chemistry, University of Kansas Lawrence

Vector Particle Characterization

Bruce A. Kerwin, PhD, Senior Vice President, Process & Product Development, Umoja Biopharma

Topic to be Announced

Matthew B. Seefeldt, PhD, Executive Director & Research Instructor, Cell Therapy & Manufacturing, University of Colorado

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

Scalable and rapid transient protein production in mammalian cells continues its evolution as an integral part of the biotherapeutic drug discovery process as well as an important tool to generate recombinant proteins for a variety of other applications. We discuss the common issues facing researchers as they try to meet an expanding demand for transiently produced recombinant protein.

  • 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?​

Future Platforms for Future Modalities

David W. Wood, PhD, Professor, Chemical & Biomolecular Engineering, The Ohio State University

Scientific breakthroughs in gene therapy and new targets and strategies have stimulated the biopharmaceutical industry to consider highly diverse molecules and delivery methods.  These new approaches will require new manufacturing methods, and like monoclonal antibodies with Protein A, platforms that can quicky bring basic scientific discoveries into the clinic will become critically important.  As we go forward and assemble new information about potential approaches it is worthwhile to stop and examine this progress.  This discussion will be designed to look at what is working and what is not, as well as the pain points and opportunities for the next core platforms that will enable the blockbuster drugs of the future.

  • 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?​

Wednesday, January 19

8:00am BuzZ Sessions with Continental Breakfast

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?

Characterization and Control Strategies for Novel Modalities

Kevin Zen, PhD, Executive Director, Chemistry, Manufacturing and Controls, AnaptysBio, Inc.

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

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?​​

Cryopreservation Challenges of Biologics, Gene Therapy, and Cell Therapy Modalities

Sanket Patke, PhD, Associate Director, Sanofi

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)

Harvesting the benefits and overcoming the challenges of collaborations between academic and industrial researchers and institutions specialized in widely spread disciplines and different geographical locations can be demanding but also include unique rewards. ​

  • How to start-up projects
  • Identifying and involving collaborators
  • Managing expectations (IP, Funding, commitment, etc..)
  • Ensuring efficient and smooth collaboration

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?

 

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?

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

The full potential of gene editing technologies in CHO cells has yet to be achieved in creating significant improvements in expression and product quality. Join this discussion group to commiserate, share your experiences, and brainstorm ideas to generate breakthroughs.

  • 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?