January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics

Session A 

TABLE 1A:  Is it Possible to Control all Stability-Indicating Issues of a Drug Candidate through Formulation Development?
Moderator:  Sharon Gao, Ph.D., Principal Scientist, Protein Sciences, aTyr Pharmaceuticals 

  • What are the best practices to evaluate drug candidate's in vivo stability. Is there a correlation between drug candidate's stability in an optimal formulation with its in vivo stability?
  • Can protein stability be predicted by modeling?
  • In today's regulatory environment, should proteinacious particles analysis be incorporated in preformulation screens?

TABLE 2A:  Putting Patients First –Do Your Users Drive Innovation?
Moderator:  Reade Harpham, Manager, Human Centric Design Health and Life Sciences, Battelle 

  • Who are the users of your product/service/drug?
  • How are they different/similar?
  • What do you do to assure their needs are met? 

TABLE 3A: Well Based Mammalian Expression of Antigen and Antibody Libraries
Moderator: Tadas Panavas, Ph.D., Senior Scientist, Molecular and Protein Biosciences, Centocor R&D, Inc.

  • Challenges with antibody v-region PCR amplification and cloning
  • Maximizing expression of diverse proteins in 96-well format
  • Process automation using a liquid handler platform

TABLE 4A:  Maximizing Success of Protein Expression in High-Throughput Fashion
Moderator:  Yvonne Franke, Ph.D., Scientist, Structural Biology, Genentech, Inc. 

  • Challenges and bottlenecks of high-throughput protein expression
  • Automation of DNA and protein purifications
  • Miniaturization of protein production in insect cells
  • Potential strategies for difficult to express proteins in E. coli and insect cells

TABLE 5A:  Subvisible Particles Characterization – The Current State of Affairs
Moderator:  Danny Chou, Ph.D., Individual Consultant, Former Head, Bioprocess Analytical Science, Genzyme 

  • What are the current best methods for quantifying and characterizing subvisible particles? 
  •  What are the pros and cons of each method and which methods are suitable for QC versus development only?
  • What are the current expectations from the FDA and other regulatory agencies for subvisible particle counting?

TABLE 6A:  Strategies for Preclinical Immunogenicity Screening:
Moderator:  Philippe Stas, head Applied Protein Services, Lonza Biologics 

TABLE 7A:  Dealing with the “Hard Nuts” in Protein Purification, and the Constant Challenge of Aggregation
Moderator:  Sabine Suppmann, Ph.D., Head, Recombinant Protein Production, Microchemistry Core Facility, Max-Planck Institute of Biochemistry MPIB 

  • Proteins that fail to purify
  • Soluble aggregates
  • How to monitor protein aggregation
  • How to prevent protein aggregation
  • How to screen buffer formulations
  • How to find a way to convince editors of Journals, especially Cell Biology Journals, to ask authors for protein data (at present there is so much rubbish published with aggregated proteins, and as such not correctly folded proteins)

TABLE 8A:  Cake Appearance for Lyophilized Drug Product: What is acceptable?
Co-Moderators:  Dr. Sajal M. Patel, Scientist, Biopharmaeceutical Development, MedImmune, and  Michael  Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut  

  • What are the typical lyo cake defects?
  • Criteria for visual cake appearance for lyophilized drug product (sharing industry perspective)
  • What are considerations for lyo cake appearance acceptance and rejection?
  • Do these considerations change during the life cycle of drug product development?

TABLE 9A:  Filing Biologics License Applications (BLAs) with the FDA
Moderator:  Paul Hanson, Ph.D., Staff Engineer II, Cambridge Biologics CMC Group, Millennium Pharmaceuticals 

  • How much detail about AORs should be in the filings?
  • For companies with small biologics pipelines, how to set AORs with limited information about critical quality attributes?
  • What are some good strategies for framing QbD results within a non-QbD filing?
  • How to progress from non-QbD to Qbd filings?

TABLE 10A:  Engineered Antibody Domains as Scaffolds and Candidate TherapeuticsModerator: Dimiter Dimitrov, Ph.D., Head, Protein Interaction Group, and Senior Investigator, Center for Cancer Research, NCI-Frederick, NIH 

  • V domain-based
  • C domain-based
  • Non-human antibody domains
  • Bispecific, multispecific, small molecule drug congugates
  • Stability, aggregation, solubility and immunogenicity
  • Pharmacokinetics
  • Safety and efficacy

TABLE 11A:  Making the Decision:  Outsourcing or In-house Protein Production?
Moderator:   Lorenz Mayr, Ph.D., Executive Director, Unit Head Biology, Protease Platform, Novartis Pharma AG / NIBR 

  • What are the key decision criteria for outsourcing of protein production?
  • How do we find good partners and maintain successful collaborations?
  • How do we manage the balance between in-house and external work?
  • What are the future trends for outsourcing and collaboration?

TABLE 12A:  Protein Structure and Aggregation Analysis – Predictive Tools for Better Formulation Moderator:  Yamuna Dasarathy, PhD, Director, Marketing, Chromatography, Pall Life Sciences 

  • Screening protein drug candidates during early process development for manufacturability (How common is this practice? - Share your experience)
  • Manual and high throughput structural, protein-protein interaction and aggregation characterization of proteins (What technology/ies do you use and why? What are the limitations?)
  • Do/can analytical measurements made early in development provide accurate predictions of a protein manufacturability and/or long term storage behavior? What measurable parameters are predictive?
  • How many technologies should be made available in a single automated instrument to perform physical stability studies of a protein? – what are your needs?
  • What challenges do you face in your lab related to physical and chemical analysis of proteins?  
  • Can improved high throughput analytical technologies help make QbD a cost effective reality for the masses?
  • What are the key current trends and drivers in the analytical characterization of biopharmaceuticals? Suggestions: More novel (challenging) molecules, changing emphasis from regulators, QbD, Follow on biologics, newly available analytical capabilities 

TABLE 13A:  Engineering Fusion Genes: Problems and Solutions
Moderator:  Aaron Altman, Molecular Biology, Pomona College 

  • What are common problems today in fusion gene discovery, design, and construction?         
  • What are the best answers to these problems?
  • What is the best way to implement these answers?
  • What are the new frontiers of fusion gene research, and what are some of the foreseeable problems?

TABLE 14A: Protein-Sugar Interactions and Protein Aggregation
Moderator:  Devendra (Davy) Kalonia, Ph.D., Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut 

TABLE 15A:  Strategies for Improving Soluble Expression in Baculovirus-Infected Insect Cells
Moderator:  W. Clay Brown, Ph.D., High-Throughput Protein Lab, Center for Structural Biology, Life Sciences Institute, University of Michigan 

  • What is the effectiveness of manipulating growth conditions – temperature, media, vessel/volume?
  • Which fusion proteins or SETs have been useful?
  • Does varying promoters for strength and timing impact solubility?
  • Are there purification techniques that solubilize protein found in the insoluble fraction?

TABLE 16A:  Biophysical Characterization of Proteins in a HTP Environment
Moderator:  Ray Owens, Ph.D., NDM Senior Research Fellow, Division of Structural Biology, Oxford Protein Production Facility, University of Oxford 

  • What is the role of biophysical characterization in the HTP protein production lab?
  • What works and what does not work?
  • What quality standards are people working to (academic vs. biotech)?

TABLE 17A:  Jason and the Argonauts MMXII-The Quest for the Golden Antibody
Moderator:  Dan L. Crimmins, Ph.D., Senior Scientist, Pathology & Immunology, Lab & Genomic Medicine, Washington University School of Medicine

  • Commercial Ab's are a "hit or miss" proposition.
  • Considerable time and resource are wasted.
  • How can investigators change this?
  • Require greater validation from vendors.
  • Availability of Ab specific, detailed application protocols.
  • Potentially  a "win-win" business proposition.

TABLE 18A:  Strategies for Half Life Extension of Therapeutic Proteins
Moderator:   Stefan Schmidt, Ph.D., M.B.A., CEO/CSO, XL-Biologics GmbH  

  • State of the art
  • Pros and cons of different approaches
  • Troubleshooting

TABLE 19A:  Discussion of Affinity Purification Tags and Fusion Proteins for Determination of Protein-Protein Interactions
Moderator:  David Bienvenue, Ph.D., Associate Director, VLST Corporation 

  • Use of multimerization domains to form high-avidity fusion proteins
  • Strategies to minimize steric hindrance and/or impact on interaction
  • Affinity tags amenable to use with chemical cross-linking to stabilize bait-target interactions
  • Methods for overcoming expression issues with complex fusion proteins
  • Methods for overcoming aggregation/stability issues with complex fusion proteins

 

Session B 

TABLE 20B:  Antibody Discovery and Engineering as Part of an Antibody Drug Discovery Program
Moderator:  Chung-Ming Hsieh, D.Sc., Associate Director, Antibody Generation Group, Abbott Bioresearch Center 

  • Choosing the right strategies for the targets: what tools are in your tool box?
  • Human vs. humanized antibodies: differences and similarities in discovery and engineering
  • Antibody properties: active engineering vs. passive screens

TABLE 21B:  Common Issues with Transient Protein Production
Co-Moderators:  Richard Altman, M.S., Research Scientist, Alexion Pharmaceuticals and
Henry C. Chiou, Ph.D., Senior Manager, Molecular Biology, Life Technologies Corporation

  • 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 22B:  Half-Life Extension of Peptides and ProteinsModerator:  Volker Schellenberger, Ph.D., CSO, Amunix, Inc. 

  • How to select a suitable method for half-life extension for a product
  • Chemical conjugation versus recombinant fusion technologies
  • Polymers versus receptor recycling
  • The effect of receptor-mediated clearance on drug half-life
  • Effect of half-life extension on immunogenicity

  

TABLE 23B: Gene Design and Optimization to Improve Protein Expression and Solubility
Moderator: Jingdong Tian, Ph.D., Assistant Professor, Biomedical Engineering, Duke University 

  • How well do current gene design and optimization methods work and what are the remaining challenges?
  • What are some of the new insights or consensus on the theory of gene design and codon optimization?
  • How can we improve protein solubility by gene design and optimization?

TABLE 24B:  Introduction to Combination Products
Co- Moderators:  Von Nakayama, Industry Advisor, and Robin Hwang, Ph.D., Independent Consultant 

  • Combination product overview
  • FDA regulation of combination products
  • Partnership considerations for biologic device combination products

TABLE 25B:  Protein Structure and Aggregation Analysis – Predictive Tools for Better Formulation
Moderator:  Simon Webster, Ph.D., Head, Analytical and Pharmaceutical Sciences, ImmunoGen
Studying protein structure and aggregation propensity early on in the process improves predictions of long term storage stability, assisting in a more rational formulation development process.

  • Do/can analytical measurements made early in development provide accurate predictions of a protein manufacturability and/or long term storage behavior? What measurable parameters are predictive?
  • Can improved high throughput analytical technologies help make QbD a cost effective reality for the masses?
  • What are the key current trends and drivers in the analytical characterization of biopharmaceuticals?

TABLE 26B:  Risk Reduction in Biotherapeutics Design by Rational Protein Engineering
Moderator:  Dr. Yvette Stallwood, Site Director, Lonza Biologics 

TABLE 27B:  Three-Phase Partitioning (TPP) Method for Protein PurificationModerator: William Ward, Ph.D., Associate Professor, Biochemistry, Center for Research & Education in Bioluminescence & Biotechnology (CREBB), Department of Biochemistry & Microbiology, Cook College, Rutgers University 

  • Fast, easy, inexpensive
  • Excellent method for purifying protein
  • Share experiences with TPP
  • Discuss results achieved

TABLE 28B:  Efficient Ultrafiltration for Academic and Bioprocess Laboratories
Co-Moderators:  Melissa Winters, Sales Specialist, Filtration and Purification Technologies, Sartorius
Michael Dosmar, Product Manager, Crossflow and Lenticular Filtration, Purification Technologies, Sartorius,  Michael Vagell, Applications Specialist, Laboratory Products and Services, Sartorius 

  • Tools for labscale ultrafiltration.
  • Easy optimization of crossflow ultrafiltration.
  • Differences between general laboratory and scalable bioprocess ultrafiltration.

TABLE 29B:  Buffer Optimization Using High-Throughput Thermal Melt Assays
Moderator:  William Gillette, Ph.D., Senior Scientist, Protein Expression Lab, SAIC-Frederick, Inc. 

  • A wide-open discussion on this relatively new topic
  • Use of Differential Scanning Fluorimetry to measure protein stability via thermally-induced protein melting/denaturation
  • Participants encouraged to come prepared to discussed their successes and problems
  • Suggested topics: instrumentation, buffers, alternative systems, signal source (native fluorescence vs. dye-based)

TABLE 30B:  Why Don't Scientists Use ELNs?Moderator:  Chris Morris, Computational Science and Engineering Department, Science and Technology Facilities Council (STFC) 

  • Have you ever:
  • Been driven mad trying to enter data into a software system?
  • Thrown away an Eppendorf because no one knows what's in it?
  • Performed a procedure without knowing it failed before?
  • Started leafing through old notebooks to find a record you need?
  • Delayed entering data because it isn't time to discuss it with others?
  • How can electronic data recording be truly suitable for research?
  • How can research practices be truly suitable for electronic data recording? This session will compare experiences of the real barriers to take on ELNs, and compare notes on solutions to them.

TABLE 31B:  Reconstitution of Lyophilized Protein
Moderator:  Robin Bogner, R. Ph., Ph.D., Associate Professor, Department of Pharmaceutical Sciences, University of Connecticut     

  • Influence of reconstitution method on reconstitution time
  • Methods of reducing reconstitution time
  • Is there a maximum protein concentration beyond which reconstitution of a lyophilized product is not practical?

TABLE 32B:  Making the Right Host Decisions for Scale-Up
Moderator:  Bjorn Voldborg, Ph.D., Scientist, Biotechnology, University of Copenhagen; Novo Nordisk Foundation 

TABLE 33B:  Characterization and Analysis of Sub-Visible Particulates
Moderator:  Tudor Arvinte, Ph.D., Professor, Biopharmaceutics, University of Geneva, CEO, Therapeomic, Inc. 

  • Different protein aggregation mechanisms
  • Influence of sample handling and solvent history on aggregation
  • Orthogonal methods
  • Non-invasive methods to detect small amounts of aggregates

TABLE 34B: Peptide Nanomedicine - The Clinician Perspective.
Moderator:  Israel (Rudi) Rubinstein, M.D., Professor of Medicine, University of Illinois at Chicago 

  • Choice of biocompatible and biodegradable nanocarriers for peptide biologics
  • Design of early in vivo safety studies of peptide-loaded nanocarriers.
  • In vivo efficacy of safety-tested peptide-loaded nanocarriers

TABLE 35B:  Baculovirus-insect cell expression systems -Vectors and Recombinant Virus Isolation.
Don Jarvis, Ph.D., Professor, University of Wyoming 

  • Cell line development
  • High throughput expression
  • Difficult protein expression
  • Products

TABLE 36B:  Protein Structure of Subunit Vaccines and Therapeutic Drugs: Induction of Immunity, Sometimes Good, Sometimes Bad.
Moderator:  Evelina Angov, M.S., Ph.D., Microbiologist, malaria Vaccine Development, Walter Reed Army Institute of Research 

  • Aggregation improves immunogenicity, is that always a good thing?
  • Can we control these processes to our benefit?
  • Case for and against affinity tags - do we really need to get rid of them?

TABLE 37B:  Understanding Packaging Systems for Parenteral Administration of Biopharmaceuticals and Biological Products
Moderator:  Vinod D. Vilivalam, Ph.D., Director, Strategic Market and Technical Development, Daikyo Crystal Zenith, West Pharmaceutical Services, Inc. 

  • Plastic prefillable syringe systems for biopharmaceutical drug delivery
  • SubQ infusion of higher volume mAb products (>1 ml)
  • Plastic vial packaging systems for cell therapy products

TABLE 38B:  How Pure is Pure?
Moderator:  David O’Connell, Ph.D., Senior Scientist, School of Medicine, University College Dublin 

  • What are acceptable limits of purity
  • Rapid methods for establishing level of purity
  • The need for high sensitivity assessment e.g., MS based analysis
  • Experiences of different tag systems

TABLE 39B:  Bioprocessing Facilities of the Future:  Key Trends and Concepts
Co-Moderators:  Rolf Douwenga and Spencer Reynolds, DSM Biologics 

  • Disposable, closed systems:  opportunities and challenges
  • Continuous flow processing
  • Facility modularity - definition and key concepts

TABLE 40B:  Antibody Characterization by Hydrogen/Deuterium Exchange Mass Spectrometry (HDX-MS)
Moderator:  Yoshitomo Hamuro, Senior Director, ExSAR Corporation
Antibody characterization has become more important with recent increased interest by regulatory authorities for companies to provide higher order structure data. Hydrogen/deuterium exchange mass spectrometry (HDX-MS) can characterize the higher order structure of an antibody and map the epitope(s) in solution.

  • Characterization of higher order structure of therapeutic antibodies in solution at sub-molecular level
  • Regulatory requirements for the characterization of higher order structure
  • Identification of an antibody’s epitope is a key component of characterization
  • IP implications

• Utilizing HDX-MS as a method for epitope mapping and for characterizing higher order structure of your antibodies

TABLE 41B: Aerosolization of Biologics
Donovan Yeates, Ph.D., CEO, Research and Development, KAER Biotherpeutics 

  • Shear induced degradation
  • Generation of particles with a density of less that one
  • Liquid nebulization v's dry powder aerosolization v's Liquid to dry aerosol delivery.

 

TABLE 42B:  New Applications of Label-free Surface Plasmon Resonance (SPR) Biosensors in Protein-Protein Interactions
Ruben Luo - Product Development Scientist, Bio-Rad Labs  

  • What developments are needed to make SPR biosensor work suitable for the study of membrane protein? Is this needed?
  • In the study of membrane proteins and vaccine development, is there a need to use whole cells as analytes?
  • How important is the regeneration capability of an SPR sensor chip? is anyone dreaming of a regeneratable amine coupling or biotin-streptavidin surface?
  • Are SPR biosensors an ideal tool for sample quantitation and quality control applications?

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