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동결건조, 분무건조 및 최신 건조 기술 유효한 처방, 주기 개발과 최적화, 규제 준수, 검증 및 스케일업을 위한 전략1월 12일∼13일
이 부회는 동결건조와 새로운 건조 기술에 관련된 최신 동향과 과제를 다루며, 과학적으로 입증된 처방, 프로세스의 최적화, 백신과 생물제제의 동결/해동과 처방상 과제, 연구개발에서 생산으로 스케일업하기 위한 전략, 용기/밀폐 시스템의 선정 등에 관한 상세한 사례연구 및 토론이 예정되어 있습니다. 처방의 최적화 Opening Keynote Presentation: Scientific Basis of QbD: Developing a Scientifically Sound Formulation and Optimizing the Lyophilization Process Michael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut Non-Invasive In-Line Monitoring of Product Temperature during Lyophilization Using Tunable Diode Laser Absorption Spectroscopy (TDLAS) Puneet Sharma, Ph.D., Postdoctoral Fellow, Pharmaceutical Sciences, University of Connecticut Innovations for Simplifying Freeze Drying Protocol Development and Optimization Matthew Ling, Manager, Research and Development, Millrock Technology, Inc. FTIR Chemical Imaging Guided Lyophilization Formulation and Cycle Development for Recombinant Human Albumin Heiko Schiffter, Ph.D., Lecturer in Engineering Science (Drug and Vaccine Delivery), Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford Optical Coherence Tomography (OCT) Based Freeze Drying Microscopy for Collapse Temperature Determination Kristyn Greco, Ph.D., Postdoctoral Fellow, Pharmaceutics, University of Connecticut Fast-Dissolving Tablet Vaccines for Enteric and Other Mucosal Pathogens Made by Lyophilization Dexiang Chen, Ph.D., Senior Technical Officer and Portfolio Leader for Vaccine Formulation, Technology Solutions Global Program, PATH
주기 개발 Vial-to-Vial Variation for Freeze-Dried Products during Primary Drying: A New Way to Approach Design Space Robin Bogner, R.Ph., Ph.D., Associate Professor, Department of Pharmaceutical Sciences, University of Connecticut Effect of Drying High-Concentration Protein Formulation at, Above and Below Tg’ Sajal Patel, Ph.D., Scientist, Biopharmaceutical Development, MedImmune Freeze Drying Above Collapse Temperatures Gerhard Winter, Ph.D., Professor, Chair of Pharmaceutical Technology and Biopharmaceutics, LMU Munchen The Importance of Controlling Nucleation Temperature during the Freeze Step Mark Shon, Vice President, SP Scientific
스케일업 Tech Transfer Considerations during Lyophilization of Highly Concentrated Antibody Formulation: Case Studies Describing Scale-Up from Laboratory to Pilot Scale Akhilesh Bhambhani, Ph.D., Senior Research Chemist, Vaccine Drug Product Development and New Technology, Merck & Co., Inc. Incorporating QbD into the Development and Tech Transfer of a Lyophilized Drug Product Phuong Nguyen, Ph.D., Scientist, Parenteral Formulation Sciences, Millennium: The Takeda Oncology Company
분무건조와 최신 건조 기술 Biopharmaceutical Powders by Various Drying Technologies for Drug Delivery and Bulk Storage Applications Mayumi Bowen, Engineer II, Pharmaceutical Processing & Technology Development, Genentech, Inc. Can We Count on Spray-Drying as a Real Alternative for Freeze-Drying? Evgenyi Shalaev, Ph.D., Associate Research Fellow, Pharmaceutical Development, Pfizer New System for the Generation and Delivery of High Concentrations of Respirable Aerosols of Biologics and Large Labile Molecules Donovan Yeates, Ph.D., CEO, Research and Development, KAER Biotherapeutics |
