凍結乾燥、噴霧乾燥、および最新の乾燥技術

有効な処方、サイクル開発と最適化、規制遵守、検証とスケールアップのための戦略

1月12日〜13日

この部会は、凍結乾燥と新たな乾燥技術にまつわる最新のトレンドと課題を網羅するもので、科学的な裏づけのある処方、プロセスの最適化、ワクチンと生物製剤の凍結/解凍と処方上の課題、研究開発から生産へとスケールアップするための戦略、容器/密閉システムの選定などに関する詳細なケーススタディや討論が予定されています。

処方の最適化

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

サイクル開発

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

スケールアップ

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

噴霧乾燥と最新の乾燥技術

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