Cambridge Healthtech Institute’s 5th Annual

Cell Therapy CMC and Analytics

Improve Product and Process Analysis and Characterization

August 24-25, 2020

 

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

 

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and regulatory requirements facing the analysis, quality control, and characterization of  cell-based therapies with unpublished, in-depth case studies and regulatory feedback on the latest analytical methods, CMC development, product release, assay development and validation, flow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

 

Cover will include, but is not limited to:

 

  • Regulatory expectations across US, Europe, and international markets
  • Automated analytics
  • Analytical methods for cell therapies - standards and new technologies, CMC strategies for cell-based therapies – preclinical to phase III
  • CQAs, CPPs, and Quality by Design
  • Raw materials and adventitious agent testing
  • Monitoring quality across the process
  • Process analytics for cell therapies
  • Potency assay development and validation
  • Comparability strategies following process change - late stage, post approval, tech transfer
  • Quality control
  • Process validation
  • In-process controls – rapid sterility testing
  • Formulation
  • Particulates

 

* The program is subject to change without notice, due to unforeseen reason.





Premier Sponsors:

NanotemperTechnologies

Vironova