Cambridge Healthtech Institute’s 4th Annual

Cell Therapy CMC and Analytics
( 細胞療法藥物的CMC與分析 )

Improve Product and Process Analysis and Characterization

2019年8月12-13日


To ensure the safe and rapid production of cell-based therapies, companies must develop well-characterized processes and products in line with regulatory expectations.

Cambridge Healthtech Institute’s Cell Therapy CMC and Analytics conference focuses on the technical and regulatory requirements needed to advance the analysis, quality control and characterization of cell-based therapies with unpublished, in-depth case studies and regulatory feedback on regulatory and CMC development, product release, assay development and validation, flow cytometry, target product profiles, critical quality attributes, critical process parameters, and product release.

Preliminary Agenda

REGULATION OF CELL-BASED THERAPIES

Regulation of Cell-Based Therapies — Latest FDA Recommendations

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

CMC Strategies for Cell-Based Therapies

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals, Ltd.

CHARACTERIZATION AND ANALYSIS

Standards and Control Strategies for Characterization of Cell Therapy Products

Sumona Sarkar, PhD, Biomedical Engineer, Biosystems and Biomaterials Division, Biomaterials Group, NIST

Flow Cytometry Assay Validation: O, the Places You'll Go

Ruud Hulspas, PhD, Independent Consultant, Cellular Technologies Bioconsulting, LLC

Cytof/Mass Cytometry Analytics for CAR-T Drug Products — Opportunities and Challenges

Katja Kleinsteuber, PhD., Scientist II, Cellular Analytics, Bluebird Bio

Outcomes of Characterization of CD34-Enriched Gene Therapy Drug Products

Ilya Shestopalov, PhD, Senior Scientist, Cellular Process Characterization and Analytics, bluebird bio

Assay Development Strategies for Cell Therapy Product Characterization

Angela Keightley, PhD, Director, Assay Development, Bluerock Therapeutics

Advancing Product Characterization for Cell Therapies

Qiong (Chelsea) Xue, PhD, Associate Director, Head Analytical Development, Cell Therapies, Pharmaceutical Sciences, Takeda Pharmaceuticals

Analytical Method Transfers to Enable Technology Transfer to Manufacturing Sites at Various Stages of Development

Junxia Wang, PhD, Director, Analytical Development, Mustang Bio, Inc.


* 活動內容有可能不事先告知作更動及調整。