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
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