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Cambridge Healthtech Institute’s Inaugural

Gene Therapy Analytics and Manufacturing
( 遺伝子治療薬の分析と製造 )

Strategies, Analysis, Process Development, and Scale-Up of Vector-Based Gene Therapies

1月21日~22日

Part of the Cell & Gene Therapies pipeline

Cambridge Healthtech Institute’s Inaugural Gene Therapy Analytics and Manufacturing conference will take an in-depth look at the challenges facing the formulation, characterization, analysis and scale up of gene therapies. The conference will examine critical challenges facing the analysis, characterization, quality control and bioproduction process development and scale-up, of viral vector-based gene therapies such as AAV, lentivirus and retrovirus.

Preliminary Agenda

REGULATIONS AND STANDARDS

Regulation and Challenges for Gene Therapy Products

Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, PAREXEL International

USP Standards Development for Gene Therapy

Jim Richardson, PhD, Senior Science and Standards Liaison, Global Biologics, United States Pharmacopeia

Discovery and Development of RNAi Therapeutics

Muthiah (Mano) Manoharan, PhD, Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals, Inc.

CHARACTERIZATION AND ANALYTICS

Characterization and Quantification of Empty and Full AAV Capsids

Qin Zou, PhD, Associate Research Fellow and Group Leader, Analytical Research and Development, Pfizer, Inc.

The Aggregation of Gene Therapy Vectors

Dinen Shah, PhD, Scientist, Biologics Product Development, Allergan

Analytical Ultracentrifugation to Assess Critical Quality Attributes of Viral Vectors for Gene Therapy

Klaus Richter, PhD, Group Leader, Analytical Ultracentrifugation (AUC) Group, Coriolis Pharma Research

PROCESS DEVELOPMENT, MANUFACTURING AND SCALE UP

Beyond Empty Capsids: Biophysics in Gene Therapy Manufacturing

Lake N. Paul, PhD, President, BioAnalysis, LLC



* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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