PepTalk's BuzZ Sessions are focused discussions in which delegates discuss important and interesting biotherapeutic related topics from 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.
BuzZ Session A | BuzZ Session B
Tuesday, January 22nd, 2013
3:30 – 4:15 pm
TABLE 22B: Next Generation Half-Life Extension: Is "Tunability" Desired and if so, How Would One Go About It?
Randall Engler, Director, Strategic Accounts, Novozymes, Inc.
- What HLE technologies offer a tunability feature?
- Some organizations are pursuing monthly dosing for some drugs; are there downsides to this effort?
- Are there regulatory challenges in such an approach that are different from other?
TABLE 23B: Selective Protein Quantification with Spectrophotometry
Philippe Stas, CEO, Trinean NV
- UV-VIS protein quantification for purified proteins only?
- Industry needs for novel quantification methods
- Alternatives for spectrophotometry
TABLE 24B: Affinity Tags in Expression and Purification of Membrane Proteins
Alexei Yeliseev, Ph.D., Staff Scientist, LMBB, NIH/NIAAA
- Use of tandem affinity tag purification
- Tags for purification of membrane receptors
- Novel methods of purification
TABLE 25B: The Potential Role of Self-Cleaving Tag Technologies in Biopharmaceutical Manufacturing
David W. Wood, Ph.D., Associate Professor, Chemical and Biomolecular Engineering, Ohio State University
- Available technologies, advantages and disadvantages of each
- Process design and process considerations
- Potential regulatory issues and process validation
TABLE 26B: Finding a Suitable Expression System for the Production of Your Protein
Heidi Roschitzki-Voser, Ph.D., Senior Scientist, Biochemistry Institute, University of Zurich
- Prokaryotic expression systems: E. coli, L. lactis...
- Eukaryotic expression systems: -Insect cell (Sf9, Tn5) – mammalian cells (COS, HEK293, HEK293T, HEK293S Gnt-, ...)
TABLE 27B: Extending the Half-Life of Peptide Therapeutics
Volker Schellenberger, Ph.D., CEO and President, Amunix
- Overview of half-life extension technologies
- What are strengths and limitations of each approach?
- Chemical conjugation versus recombinant fusion
- Half-life extension versus slow release
- Regulatory hurdles
TABLE 28B: Linkers in Recombinant Fusion Proteins
Wei-Chiang Shen, Ph.D., John A. Biles Professor, Pharmaceutical Sciences, School of Pharmacy, University of Southern California
- Expression and production
- Biological activity and efficacy
- Other properties of fusion proteins
TABLE 29B: Using Recombineering for DNA Fabrication
JrGang Cheng, Ph.D., Associate Professor, Center for Neuroscience, University of North Carolina Chapel Hill
- Which system to use: recombinogenic bacteria or plasmids?
- Concerns with the modification of high copies plasmids
- Working with large construct such as BAC (Bacteria Artificial Chromosome) for transgenesis
- Challenge of bacteria chromosome editing beyond E. coli
TABLE 30B: High-Level Secreted Expression of Therapeutic Proteins / Enzymes in Pichiapastoris (or yeasts in general)
Roland Weis, Ph.D., Head of Operations, VTU Technology
- Are yeasts still "weirdos" for protein production?
- N-glycosylation and other PTMs
- High throughput methods for microbial eukaryotic protein production
- Novel accomplishments with Pichia/yeasts
TABLE 31B: Engineering Protein Therapeutics for Device Compatibility
Bob Kelley, Ph.D., Senior Scientist, Drug Delivery, Genentech
- Early sequence evaluation for high concentration formulation and stability
- Overcoming instability in physiological conditions
- Need for improved computational and experimental methods forstudying proteins at high concentration
- Animal models for uptake from subcutaneous space
- Understanding clearance from ocular tissue
TABLE 32B: QbD in Freeze Drying and Design of the Freezing Process
Michael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut
- What is "Design Space"?
- What is the role of "Design of Experiments" in QbD for Freeze DriedProteins?
- What is the meaning of "Validation" within the contest of QbD?
TABLE 33B: Pulmonary Delivery of Drugs/Vaccine
Tarun Mandal, Ph.D., McCaffrey/Norwood Endowed Professor of Pharmacy & Director, Center for Nanomedicine & Drug Delivery, College of Pharmacy, Xavier University of Louisiana
- Is the pulmonary delivery right for your molecule?
- Delivery via oral vs. nose
- Local vs. systemic action
- Impact of particle size on lung deposition
TABLE 34B: Detection of Protein Aggregation in the Solid State
Evgenyi Shalaev, Ph.D., Research Investigator, Allergan
- Protein aggregation is a major stability issue in various systems, such as during storage of freeze-dried formulations or in controlled release dosage forms (e.g., PLGA microspheres)
- Protein aggregation is usually measured after a solid material is dissolved
- It would be important to detect if protein aggregates are formed in the solid state
TABLE 35B: Strategies for Dose Reduction
David Meininger, Ph.D., Executive Director, Molecular Discovery, Merck
- Enabling active transport into target tissue
- CMC engineering
- Catabolic/pH-sensitivity engineering
TABLE 36B: Multipass Membrane Protein Monoclonal Antibody Discovery
James W. Stave, Ph.D., Senior Research Fellow, SDIX
- Membrane-dependent epitopes, topology and size of extracellular loops
- Orthologs and immunogenicity
- Immunization and screening strategies
- Single cell isolation, mab gene cloning and expression strategies
- Epitope mapping, mab diversity and function
TABLE 37B: Utilizing Microenvironments to Improve CHO Results
Kevin Sunley, Ph.D., Senior Scientist, XBiotech USA
- Understanding microenvironment components
- Choosing the most pliable environments
- Applying the results to expression
TABLE 38B: How to Use Modeling to Improve CHO Production Outcomes
Kyongbum Lee, Ph.D., Associate Professor & Acting Chair, Department of Chemical & Biological Engineering, Tufts University
- Choosing the correct model
- Data analysis for enhanced outcomes
- What the model should tell you
TABLE 39B: External Sourcing Strategic Objectives
Brian Cain, Ph.D., Key Account Executive, Sales, Blue Sky Biotech, Inc.
- Can strategic outsourcing be used to help increase innovation?
- What best practices exist to utilize strategic outsourcing to increase innovation and can they also be used to help increase output?
- How can outsourcing fit into your current strategy?
TABLE 40B: How Can Label-Free Binding Analysis Technologies Such as BLI and SPR be More Useful in Characterizing Protein and Antibody Therapeutics?
Sriram Kumaraswamy, Ph. D., Global Director of Applications, Marketing, Pall FortéBio
- Areas where label-free assays are currently used in your organization for biotherapeutics discovery and characterization
- Benefits accrued from adopting label-free assays
- Assays that are currently on your wish list for addressing through label-free technology
TABLE 41B: Decreasing Costs through Industry/University Cooperative Centers
Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
- What are I/UCRCs and how do they function?
- What are their immediate and long-term benefits to companies?
- What sort of research fits well
TABLE 42B: Incorporating Human Factors
Moderator: R. Reade Harpham, Manager, Human Centric Design, Battelle Memorial Institute
- Understand the difference between Human Factors research and Market Research
- Why Human Factors is here to stay
- Lessons Learned – What NOT to do
BuzZ Session A | BuzZ Session B