Cambridge Healthtech Institute ’s 3rd Annual

Cell Therapy CMC and Analytics

August 13-14, 2018

To ensure the quality, safety and rapid production of cell therapies, companies must keep on top of their CMC and analytical strateigies. However, cell-based therapies are extremely complex to analysis with high variability.

Cambridge Healthtech Institute’s Cell Therapy CMC and Analytics meeting focuses on the technical and regulatory requirements needed to advance the analysis, quality and development of cell therapieswith in-depth case studies and regulatory feedback on 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 Japan
  • CMC strategies for cell therapies – Phase I 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 Friday, February 9.

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