Cambridge Healthtech Institute’s 4th Annual
Cell Therapy CMC and Analytics
Improve Product and Process Analysis and Characterization
August 12-13, 2019
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requirements needed to advance the analysis, quality control and characterization of cell-based therapies with unpublished, in-depth case studies and regulatory feedback on regulatory and CMC development, product release, assay development and validation, flow cytometry, target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.
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.
* The program is subject to change without notice, due to unforeseen reason.