Cambridge Healthtech Institute’s Inaugural
Gene Therapy Analytics and Manufacturing
( 基因治疗药的分析和制造 )
Strategies, Analysis, Process Development, and Scale-Up of Vector-Based Gene Therapies
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.
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