PRE-CONFERENCE DINNER SHORT COURSES*
SC1: Production Challenges for Complex Biologics: ADCs, Bispecifics and Fusion Proteins
This course addresses the typical production issues encountered with complex biologics, namely fusion proteins, antibody-drug conjugates and bispecific antibodies. Experts elucidate the structure and nature of these biologics in order to understand and master their properties. Along with exploring manufacturing challenges, the course also reveals how to overcome these challenges with practical insights and advice.
Stefan Schmidt, Ph.D., Vice President, DSP, Rentschler Biotechnology
Christopher D. Thanos, Ph.D., Director, New Molecular Entities, Halozyme Therapeutics, Inc.
SC2: The S-Score System: A Tool for Identifying New Cancer Targets for Antibody-Drug Therapy - Detailed Agenda
The course discusses a new method that aids identification and prioritization of predicted cancer genes for future analysis. It generates a gene-specific “S-score” by incorporating data from different analysis types. I present results where this method was applied to Cancer Genome Atlas data for identification of oncogenes and tumor suppressors, a web server allowing users to query the system with clinically relevant issues and case studies where the S-score has helped identify targets for antibody-based therapy.
Sandro J. de Souza, Ph.D., Professor of Bioinformatics, Brain Institute, UFRN, Brazil; President, Institute of Bioinformatics and Biotechnology, Brazil
SC3: A Rational Approach to Formulation Development of Biologic Therapeutics - Detailed Agenda
The course offers a forum discussing how to develop formulation for biologic drugs. Case studies demonstrate how to incorporate Quality-by-Design (QbD) concept to design multivariate experiments, how to obtain representative data and how to analyze data in order to propose sound formulation of drug substance or drug product in the context of designated container closure systems. The course will combine how-to suggestions and real-world examples in an interactive discussion.
Steven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D
Kevin Zen, Ph.D., Senior Manager, Biologics Development, Allergan
SC4: Genome Editing Using CRISPR - Detailed Agenda
Mammalian cells are the workhorses for biopharmaceutical production. Thus, genome engineering/editing of these hosts to improve product quality and yields are of great interest. CRISPR, the newest gene editing tool, is gaining popularity among protein engineers and cell line developers. This course provides an introduction to CRISPR technology and insights on implementation for your protein expression and production pipeline.
Helene Faustrup Kildegaard, Ph.D., Co-Principal Investigator, Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark
Norman Garceau, Ph.D., CSO, Blue Sky Biotech, Inc.
Deepak Reyon, Ph.D., Scientist I, Genetically Engineered Model Center, Biogen Idec
SC5: Accelerated Stability Testing of Biologics - Detailed Agenda
This short course guides the researcher in designing studies for accelerated stability testing of biologics. The course begins with basic underlying concepts governing protein drug product stability, and focuses on design principles for measuring stress and accelerated stability testing of not only the protein of interest, but also excipients and primary packaging components. Strategies to handle complexities arising from their interactions will also be discussed.
Yatin R. Gokarn, Ph.D., Drug Product and Device, Biologics Development, Gilead Sciences, Inc.
Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.
SC6: Establishing the Business Case for Single-Use and Continuous Processing - Detailed Agenda
This short course introduces attendees to the paradigm shift and a new way of economic and manufacturing considerations for implementing single-use systems and continuous processing. Based on case studies, projects and available data, we establish a platform for drug manufacturing that is robust, streamlined, sustainable and energy saving, and at the same time reduces COGS and carbon print, culminating towards a more streamlined operation for either batch or continuous processing.
Robert Dream, PE, CPIP, CPMP, Ph.D., Principal, HDR Company Ltd.
DINNER SHORT COURSES*
SC7: Targeting of GPCRs with Monoclonal Antibodies - Detailed Agenda
While GPCRs (G protein-coupled receptors) are important therapeutic targets, it has been challenging to discover therapeutically relevant antibodies against them. This course examines different steps along the anti-GPCR antibody discovery pathway and highlights various approaches to accomplishing each step. Topics include: 1) Antibody discovery, 2) Assays to measure antibody binding, 3) In vitro assays to measure functional activity of the antibody, and 4) Review of promising GPCR targets and antibodies in the clinic.
Barbara Swanson, Ph.D., Director, Research, Sorrento Therapeutics, Inc.
SC8: Affecting Effector Function: Engineering the Fc Region - Detailed Agenda
There are a growing number of antibodies and Fc fusion proteins in development that contain a modified Fc region, either via changes in amino acid sequence or in glycoforms. Engineering antibodies and Fc fusion proteins has become more sophisticated at generating molecules that are better suited to the pharmacological activity required. This course focuses on characterizing and engineering effector functions in order to create more effective therapeutics.
Tomoyuki Igawa, Ph.D., Manager, Antibody Engineering Group, Discovery Research, Chugai Pharmaceutical Co., Ltd.
Futa Mimoto, Ph.D., Researcher, R&D, Chugai Pharmaceutical Co., Ltd.
Steven Chamow, Ph.D. Principal Consultant, Chamow & Associates, Inc.
Tilman Schlothauer, Ph.D., Senior Scientist, Protein Analytics, Roche Diagnostics GmbH
SC9: Protein Aggregation: Mechanism, Characterization and Consequences - Detailed Agenda
Protein aggregation is recognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute of biotherapeutic products. Various aggregates hold the potential for adversely impacting production and patients in a variety of ways. This in-depth workshop reviews the origins and consequences of aggregation in biotherapeutics, and then examines strategies for predicting and quantifying aggregation in biopharmaceuticals. It benefits scientists engaged in development, production, analytical characterization and approval of biotherapeutics and who require a good working knowledge of protein aggregation.
Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
David F. Nicoli, Ph.D., Vice President R&D, Particle Sizing Systems, LLC
SC10: Transient Protein Production in Mammalian Cells - Detailed Agenda
This short course introduces both the fundamental concepts and technologies needed to establish transient protein production in mammalian cells. This allows for the rapid generation, purification and characterization of milligram-to-gram quantities of secreted or intracellular recombinant proteins for therapeutic, functional and structural studies. The course combines instruction and case studies in an interactive environment.
Richard Altman, MS, Research Scientist, Molecular Sciences, Alexion Pharmaceuticals
Henry C. Chiou, Ph.D., Associate Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.
SC11: Materials in Contact with Biologics: Understanding Risk to Quality and Safety - Detailed Agenda
Materials that contact biologics during manufacturing, storage and final packaging can pose risks to biopharmaceutical quality. This in-depth course reviews the regulatory requirements, types of materials used and material chemistry, and then examines the strategies for prediction and risk assessment of potential threats to quality and safety of biologics drug products. The course reviews development of a successful analytical strategy for single-use components, container closure components and risk posed by leachables.
Diane Paskiet, Ph.D., Director, Scientific Affairs, West Pharmaceutical
Jeffrey Carter, Ph.D., Strategic Projects Leader, GE Healthcare
SC12: Protein Purification Strategies: Dealing with Proteins that Are Prone to Aggregate - Detailed Agenda
This course provides a comprehensive and detailed outline of hands-on issues for purifying proteins. We first address general considerations about the protein we want to produce, including issues of activity, solubility, homogeneity, purity and proper oligomeric conformation. Aggregation is one of the main obstacles in protein production, so we look at how to monitor for aggregation and comprehend its mechanism. We also discuss how to check for the optimal solubility conditions at the expression level, and our comprehensive approach for optimizing solubility during purification. We also discuss expression screening methodology, environmental factors to consider during purification, families of additives and screening for additives. Lastly, we address ways to avoid aggregation, as well as setting up protein concentration and storage.
Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, Hebrew University of Jerusalem
SC13: Continuous Processing of Therapeutic Proteins in Single-Use: Technology and Production Concept - Detailed Agenda
The course demonstrates how each unit operation in a typical mAb process can be run continuously and also shows how these unit operations are integrated into a truly continuous process. We also demonstrate how the combination of continuous processing and single-use technology can be implemented in a production facility. GMP-compliant production aspects such as process control, automation, PAT, process robustness, quality assurance and facility will also be discussed.
Jørgen Magnus, Ph.D., Manager, R&D, Bayer Technology Services GmbH
*Separate registration required