National Biotechnology Conference 2009 Preliminary Program - (Page 9) CONFERENCE PROGRAM - TUESDAY Moderators Andy Boswell, Ph.D. Genentech Kedan Lin, Ph.D. Genentech are essential for accurately mapping the multidimensional Design Space in which quality is ensured, control and monitor of process through PAT to provide processes which consistently generate products of predetermined quality and utilizing quality Risk Management within the given process (e.g., FMEA). This symposium will bring together industry and regulatory experts and create a platform to share advances in the area of application of QbD concepts as applied to development and manufacturing of a lyophilized protein product including process development and design, process characterization, process monitoring, validation and regulatory filing. Moderators Henning Gieseler, Ph.D. University of Erlangen Lavinia Lewis, Ph.D., M.S. Pfizer Global Biologics Pharmaceutical below 10 um. This session will attempt to create an understanding of the regulatory expectations and the practical experience around this topic. Speakers to be Announced In Vitro In Vivo Correlations for Antibody-drug Conjugates Kedan Lin, Ph.D. Genentech 10:30 am – 6:00 pm AAPS Exposition 10:30 am – 6:00 pm Antibodies and Antibody Fusion Proteins Sherie Morrison, Ph.D. University of California, Los Angeles AAPS Career Center 10:00 am – 6:00 pm Tumor Targeting Theory Dane Wittrup, Ph.D. Massachusetts Institute of Technology Contributed Papers Poster Session 12:00 pm – 1:00 pm Antibody In Vitro In Vivo Correlations: Case Studies Bernard Scallon, Ph.D. Johnson & Johnson BioTalk Join conference symposia and roundtable speakers to share ideas, experiences, and pose questions about the speakers’ research and presentations. All attendees at the National Biotechnology Conference are invited to participate in this event. BioTalk is an informal luncheon networking opportunity in the exhibit hall. Tables will be identified with the speaker’s topic. Share ideas about complementary technology, new business ideas, or simply pose questions to clarify the speakers’ presentation. Lunch will be available for purchase in the exhibit hall. PAT & Quality by Design in Freeze Drying: A Quick Review Henning Gieseler, Ph.D. University of Erlangen, Germany 9:00 am - 11:30 am PAT and QbD in Freezedrying: Where are We Now? SYMPOSIUM PAT for Sublimation End Point Detection: A Comparison of Methods Michael Pikal, Ph.D. University of Connecticut Most degradation pathways for biologics are mediated by water. Freeze-drying is an attractive alternative that removes water and preserves the biologic in the solid state. Freeze-drying is a three step process controlled by only three parameters, namely temperature, pressure and time and is based on the principles of heat and mass transfer. Process Analytical Technology (PAT) in freeze-drying should not only monitor the freeze-drying process but should also create feedback loops that allow process changes and therefore control. However, the implementation of PAT in freeze-drying is riddled with challenges since the mode of operation needs to be noninvasive and compatible with sterile practices. In the biotech industry, this issue is further compounded by cost of material or API which often precludes successful implementation of PAT. The U.S. Food and Drug Administration (FDA) rolled out the initiative of quality by design (QbD) a few years ago based on the principles of the International Conference on Harmonisation (ICH) Q8, Q9, and Q10 and encouraging the biotechnology industries to embrace it. The FDA strongly believes that quality cannot be tested into products but should be built-in or designed. The standards around three important elements, Design Space, PAT and Risk Management that constitutes the QbD are being jointly developed by the Center for Biologics Evaluation and Research and biotech industries as part of the pilot program. Development of a lyophilized protein product is a challenge in itself and applying QbD principles to it will add more complexity. It requires a through understanding and application of the tools and methods that Real-time, Non-intrusive, Water Vapor Mass Flow Measurements Used for Vial Heat Transfer and Product Temperature Determinations Bill Kessler, Ph.D. Physical Sciences, Inc. 1:00 pm - 3:30 pm Rational Protein Design Via Computational Modeling SYMPOSIUM QbD in Biopharmaceuticals Erwin Freund, Ph.D. Amgen, Inc 9:00 am – 10:30 am Closing the Gap – Characterization and Control of Subvisible Protein Particles HOT TOPIC Aggregation has always been a significant concern in the development of protein therapeutics. However, a recent publication (Carpenter et al, jps.21530) highlights certain limitations in the ability to measure aggregates which grow in size to become colloidal particles in the subvisible size range between 0.1 to 10 um. These protein-based particulates represent aggregates that are not measured by conventional SEC methodology and are also not counted in the USP particulates requirements. Expectations have been conveyed by the regulators on the need to monitor subvisible particulates Usually, naturally occurring proteins are not evolved to be useful as drugs, and therefore, additional structure optimization is often required. Sequence optimization is a useful strategy to improve several properties of a potential protein drug, such as stability, affinity, specificity, solubility, immunogenicity and pharmacokinetic (PK) properties, in order to obtain a variant with the desired characteristics. Several methods have been developed to obtain optimized protein variants, including “classical” protein engineering approaches (expert design), molecular or directed evolution methods and, more recently, computational protein design. Computational protein design steps with in silico screening/selection, permitting virtual screening of a much larger sequence space than is experimentally possible with selection methods or high-throughput screening techniques. Rational design of protein engineering via computational modeling in recent years has resulted in impressive outcomes in protein drug discovery and development. The talks in this symposium will focus on rational design of various protein drugs. The proteins are engineered to improve their functions. The lectures will include the rational design, preparation of 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 9 PRELIMINARY PROGRAM
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.