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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