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requirements needed to advance the analysis, quality control and characterization of cell-based therapies with unpublished, in-depth case studies and regulatory feedback on regulatory and CMC development, product release, assay development and validation, flow cytometry, target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.

Coverage will include, but is not limited to:

  • Regulatory expectations across US, Europe and international markets
  • CMC strategies for cell-based therapies – preclinical to Phase III
  • Defining your target product profile
  • CQAs, CPPs and Quality by Design
  • Monitoring quality across the process
  • Process analytics for cell therapies
  • Automated analytics
  • Analytical methods for cell therapies – standards and new technologies
  • 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
  • CMO management and tech transfer
  • Formulation
  • Particulates

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for priority consideration is February 11, 2019.

All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Cambridge Healthtech Institute
Phone: 781-247-6266

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359

Companies L-Z
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412