Cell Therapies

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Contacts

Cell Therapy Management Team

Facility Director:
William Janssen, PhD

Facility Manager:
Renee Smilee, MT (ASCP) - (813) 745-3961

Quality Assurance Supervisor:
Martha Hackett, MPH

Laboratory Technical Supervisor:
Albert Ribickas, MT (ASCP), HP, SBB

Apheresis Technical Supervisor:
Darlene Rahn, BS, MT, HP (ASCP)

Quality Control/Immune Monitoring Supervisor:
Mian Xu, MT (ASCP), MS

Cell-Therapies-Logo.jpg 

The goal of the Cell Therapies Core (CTC) is to manufacture safe therapeutic cellular products in support of investigator-initiated clinical studies. The CTC helps maintain compliance with standards set by the U.S. Food and Drug Administration (FDA) and several other agencies.

The CTC also supports immunological monitoring of study patients after test therapies. The CTC facility is registered with the FDA as a “Human Cell and Tissue Product” manufacturer. It is also accredited by the Foundation for Accreditation of Cell Therapy, by AABB (formerly American Association of Blood Banks), and by the College of American Pathologists. The faculty is CLIA (Clinical Laboratory Improvement Amendments) certified.

The CTC’s key areas of activity are:

  • New cell products undergo development, pre-clinical development, testing, and validation
  • Cell collection to obtain the necessary patient self-donated cells for making cell therapy products. Obtaining immune system cells (lymphocytes and antigen presenting cells, e.g., dendritic cells) for large-scale immune monitoring studies
  • Therapeutic cell product manufacturing
  • Frozen storage for cell products collected well in advance of intended use
  • Running an analytic laboratory that oversees testing quality and post-treatment immune monitoring
 
 
 
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