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.

If you would like to moderate a BuzZ Session table, contact Mary Ann Brown at mabrown@healthtech.com.

TUESDAY, JANUARY 19 | 12:20-12:50 PM

Techniques for Aggregation Mechanism Determination 
Elizabeth S. Hecht, PhD, Associate Scientist, Microchemistry, Proteomics & Lipidomics, Genentech, Inc. 

• Modeling 
• Technology application 
• in vitro versus in vivo aggregation modeling 

Host Cell Protein Coverage Analysis 
Santoshkumar L. Khatwani, PhD, Associate Director, Analytical Development, Sangamo Therapeutics 

• Different types of methods (2D, Western, AAE, LC-MS) for HCP coverage analysis 
• Phase appropriateness of the coverage analysis 
• Custom ELISA vs Commercial HCP ELISA 
• Future of HCP coverage analysis by LC-MS 

Common Issues with Transient Protein Production
Richard Altman, MS, Staff Scientist, Thermo Fisher Scientific
Henry C. Chiou, Ph.D., Associate Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.

• What are the current challenges to transient protein production?
• What are the keys to optimizing expression?
• What scale of expression and level of throughput are commonly being used?
• HEK293 versus CHO?
• Characterization of transiently produced proteins
• How to optimize the protein expression workflow?

• Hit to lead (session feedback)
• Early-stage biologics development
• Late-stage biologics development

When Time Really Matters: Will the Next Emergency Protein Fit into Your Pipeline?
William Gillette, PhD, Principal Scientist, Protein Expression Laboratory, Leidos Biomedical Research

• What expression platforms might you need to ramp up?
• To clone or bring in plasmids/cell lines?
• Are your screening platforms (both expression and purification) up to the task?
• Expect the unexpected: flexibility in staffing (e.g. social distancing)
• Project tracking and communication; what needs to change?

WEDNESDAY, JANUARY 20 | 8:15-8:45 AM

Discovery Strategies: From Human B Cells to mAbs
Scott Dessain, MD, PhD, Professor, Clinical Oncology and Research, Lankenau Medical Center; CSO, OCMS Bio

• Antigen selection for high throughput mAb screening applications
• Hit to lead strategies in mAb discovery
• Patient sourcing strategies
• Complementary technologies for collaborative mAb discovery

Digitally Optimized Analytical Workflows: Merging of Digital Tools with Experimental Analytical Studies
Cesar Calero-Rubio, PhD, Scientist, Biologics Drug Product Development & Manufacturing, Sanofi

• High-throughput automation and on-the-fly data analysis
• Mechanistic and first-principle data modeling, predictions and decision making
• Regulatory challenges and best practices

Analytical Challenges in Cell and Gene Therapies
Kuldip Sra, PhD, Executive Director, Tech Operations, CRISPR Therapeutics

Glycosylation of Therapeutic Proteins
Bjørn Voldborg, MSc, Director, CHO Cell Line Development, Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark

• Why is it important?
• How do we handle it?
• Future perspectives

THURSDAY, JANUARY 21 | 12:20-12:50 PM

Trends to Improve Drug Efficacy While Reducing Side Effects
Anass Jawhari, PhD, Independent Consultant

• How can novel cell therapy approaches contribute to successful drug discovery? What are the trends?
• Why can improved ADCs be key to reducing toxicity while maintaining efficiency? What will be the next generation of ADCs?
• How can local administration of antibodies help reduce on-target toxicity? What about indications other than Cancer?
• Engineering versus working with the native target. What strategy to adopt?
  

Raw and Starting Materials
Jim Richardson, PhD, Senior Science and Standards Liaison, Global Biologics, U.S. Pharmacopeia

• Risk categories associated with materials used for manufacturing cell and gene therapies​
• Qualification of the vendor supplying raw materials
• Use of research grade materials in CGT manufacturing

Protein Engineering to Aid Cell Therapy
Lawrence A. Stern, PhD, Assistant Professor, Department of Chemical & Biomedical Engineering, University of South Florida

• What qualities of protein building blocks should we consider when building synthetic receptors?
• How can we combine engineered proteins with cell-based therapies to optimize treatment?
• What types of synthetic receptor architectures empower multi-functionality?

Amyloid Induction
Rizwan Hasan Khan, PhD, Professor, Interdisciplinary Biotechnology, Aligarh Muslim University

• Amyloid induction in different classes of protein
• Detection by spectroscopy
• Inhibition by small molecules

Protein Tag Technologies
Richard Altman, MS, Staff Scientist, Life Science Solutions, Thermo Fisher Scientific
Dennis Karthaus, MSc, Group Leader Cell Culture Sciences, IBA Lifesciences
Alexei Yeliseev, PhD, Staff Scientist and Leader, Protein Expression Group, NIH
David Wood, PhD, Professor, Chemical and Biomolecular Engineering, Microbiology, Chemistry & Biochemistry, Ohio State University
Dominic Esposito, PhD, Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research

• How do you select an affinity tag?
• New tags and tag technologies: Better tags and better tag removal
• Are there regulations (FDA, EMA) regarding cleaving affinity tags?
• When does it make sense not to cleave the tag? Are there complications?
• Application of affinity tags to expression and purification of membrane proteins
• High affinity tag/resin pairs for purification of proteins expressed at low levels
• Costs, benefits and risks of tags: When are they worth it and when are they not?
• Affinity alternatives to tags: Bespoke resins and conventional processes

Where are the New Expression Systems for Production of Non-antibody Proteins?
Edward Kraft, PhD, Senior Scientific Manager, BioMolecular Resources, Genentech

• Do we have good protein production cell lines and/or expression systems to support this work?
• Are there forgotten technologies of the past that are worth revisiting?
• Have we painted ourselves into a corner by having a world too focused on CHO?
• What is your experience with using antibody-optimized expression systems for producing challenging proteins?
• Are those advocating niche expression systems missing the mark by not considering end-to-end feasibility of using their systems in HT-focused biotech space?