PepTalk 2017
PepTalk 2017


Buzz Session 

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

BuzZ Session A: 

Tuesday, January 22nd, 2013
2:00 – 2:45 pm

TABLE 1A: Characterization of Multivalent Antibody Such as Bispecific and Recombinant Polycolonal Antibody

Sharon Gao, Ph.D., Principal Scientist, Protein Development, aTyrPharma

  • Analytical method development
  • Stability testing
  • Manufacturability evaluation

TABLE 2A: How Do We Make a Completely Single-Use DSP Process, & Do We Even Want it?

Spencer Reynolds, Director, New Business Development, DSM Biologics

  • What are the most common, and most challenging, DSP steps incorporating single use technology?
  • What are the drivers for single-use DSP technologies?
  • Will the industry go all the way towards single-use DSP, and what will be the progression?

TABLE 3A: Strategies to Tackle Aggregation Problems during Purification

Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, The Hebrew University of Jerusalem

  • How do you check soluble aggregates?
  • At what purification step is better to eliminate the soluble aggregates?
  • What additives you prefer to use?
  • What about the use of low concentration of unfolding agents as urea or guanidine HCl?
  • Buffer screening for protein solubility: thermofluor, commercial kits, others
  • Use of reducing agents for proteins with free Cis plus disulfide bridges

TABLE 4A: Beyond Monoclonal Antibody Purification: A Universal Approach for Protein Purification for the Biotherapeutic Pipeline?

David O'Connell, Ph.D., Senior Scientist, School of Medicine, Conway Institute of Biomolecular & Biomedical Research, University College Dublin

TABLE 5A: The Intracellular Targeting of Biotherapeutics

Rachel Rennard, Senior Scientist, Merrimack Pharmaceuticals

  • Ways to deliver biotherapeutics into the cell
  • Escape of therapeutics from endosomes
  • Targeting therapeutics to organelles

TABLE 6A: Protein Polymer Pharmacokinetics

J. Andrew Mackay, Ph.D., Assistant Professor, Pharmacology & Pharmaceutical Sciences, University of Southern California

  • What is an achievable and useful target for clearance and half-life in mice and men?
  • Should the target be dextran, PEG liposomes, free PEG? mAB?
  • Mechanism of biodegradation
  • Influence of immune response

TABLE 7A: Common Issues with Transient Protein Production

Richard Altman, Research Scientist, Alexion Pharmaceuticals

Henry C. Chiou, Senior Manager, Molecular Biology, Life Technologies

Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, SAIC-Frederick

  • What are the current challenges to transient protein production?
  • What elements of transient protein production represent the greatest hope for optimization?
  • What scale of expression is most relevant? Is bigger always better?

TABLE 8A: Challenges in Removal of Solubility Fusion-Tags from Recombinant Proteins

Yoav Peleg, Ph.D., Research Scientist, Biological Chemistry, The Israel Structural Proteomics Center (ISPC), Weizmann Institute of Science

  • Is there any protease which has better cleavage efficiency than others?
  • What are the factors affecting the efficiency of the cleavage- fusion-tag used, size of recombinant protein, others?
  • Is it possible to minimize protein precipitation following removal of the tag?

TABLE 9A: Different Strategies to Block Cytokine Action

Arieh Gertler, Ph.D., Professor, Biochemistry, Nutrition and Food Science, Hebrew University of Jerusalem

TABLE 10A: Challenge in Formulation Tech Transfer to a CMO

Mark Yang, Ph.D., Director, Fill Finish Development, Genzyme

  • Is your formulation ready for tech transfer?
  • The common problems in this process
  • The things you should avoid

TABLE 11A: Scale-Up Issues in Freeze-Drying: What Have We Learned from Pressure Variation Studies in the Chamber?

Arnab Ganguly, Graduate Research Assistant, Aeronautics & Astronautics, Purdue University

  • The role of shelf separation in batch uniformity & drying time
  • The design, size of the dryer and duct location with respect to the product placement have a significant effect on batch uniformity
  • How can a coupled sublimation/condensation model help improve scale-up?

TABLE 12A: Improving Lyophilization by Annealing

Charlie (Xiaolin) Tang, Ph.D., Associate Director, Formulation Development, Regeneron Pharmaceuticals

  • Reducing lyophilization duration and improving cake structure byannealing
  • Annealing conditions in amorphous system
  • Maximizing crystallinity by optimal anneal step

TABLE 13A: Protein Buffer Optimization

William Gillette, Ph.D., Senior Scientist, Protein Expression Lab, SAIC-Frederick, Inc., Frederick National Laboratory for Cancer Research (FNLCR), NIH

  • Discuss the available systems and the pros and cons
  • Focus on primary data, please bring and be ready to share with thegroup the nuances of interpreting the data
  • What can you realistically expect to achieve?

TABLE 14A: Solving Problems in CHO during Process Development

Natalia Gomez, Ph.D., Scientist II, Group Leader, Cell Culture Process Development, Process Sciences, Agensys, Inc., an Affiliate of AstellasPharma, Inc.

  • Choosing the right CHO cell line for process development
  • Setting realistic process development goals appropriate to developmentphase
  • High-Throughput systems used during process development
  • Comparison of small-scale results to pilot/GMP scales and scale-uptroubleshooting

TABLE 15A: Fine-Tuning Automation in the Development of CHO Cell Lines

Shuangping Shi, Ph.D., Principal Scientist, Bioprocess Development, Merck & Co.

  • Understanding the variables in automation techniques
  • Deciding which components to alter
  • What to expect from your changes

TABLE 16A: Immunogenic Risk of Biotherapeutic Aggregates: Developability Meets Safety

Sandeep Kumar, Ph.D., Principal Scientist, Biotherapeutics Pharmaceutical Sciences R&D, Pfizer, Inc.

  • Bioinformatic analysis
  • In vitro /ex-vivo experiments
  • Animal models and clinical studies

TABLE 17A: Rational High-Concentration Formulation

Thomas Laue, Ph.D., Professor, Biochemistry & Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

  • What protein properties spell formulation trouble?
  • Not all detergents are the same - what are the differences?
  • What is a dipole movement & how can you tell if your protein has one?
  • Should all solvent cations and anions be considered equivalent?

TABLE 18A: Subvisible Particle Analysis for Protein Therapeutics – Current Methods, Challenges & New Trends

Andrea Hawe, Ph.D., Head of Scientific Development, Biopharmaceutical R&D, Coriolis Pharma

  • Emerging techniques – what can they add to the existing methods?
  • What are the current expectations of the authorities for submicron anmicron particle analysis?
  • How to select the best methods for subvisible particle characterization both in R&D and for QC-analysis?

TABLE 19A: Lean Startup in the Biotech World

Ellen Brune, Ph.D., Doctoral Academy Fellow, Ralph E. Martin, Dept. of Chemical Engineering, University of Arkansas

  • What are the challenges to a lean biotech startup
  • How can these difficulties be addressed?
  • Where can collaboration with a larger/more established entity be helpful?

TABLE 20A: Best Strategies for Endotoxin Removal from Protein Preparation

David Mead, Ph.D., CEO and Founder, Lucigen Corporation

  • What is current method for removal?
  • What is best method for removal? At what scale?
  • How do you know it is endo free? What method do you use for measuring? What level is acceptable?
  • Animal vs. tissue culture differences?

BuzZ Session A | BuzZ Session B