凍結乾燥、噴霧乾燥及最新的乾燥技術

有效處方、循環開發與最適化、遵守法規、驗證和按比例增加（scale up）的策略

1月12日∼13日

此部會網羅與凍結乾燥及新的乾燥技術有關之最新傾向和課題，亦預定舉行有關科學已證實的處方、製程最適化、疫苗和生物製劑的凍結/解凍及處方上的課題、從研究開發到按比例提高生產的策略、容器/密閉系統的選定等詳細之個案研究及討論。

處方最適化

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

循環開發

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�f

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

按比例增加（scale up）

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

噴霧乾燥和最新的乾燥技術

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