Therapeutic Cell Production Services

Cell Processing Services

The current Therapeutic Cell Production Shared Resource (TCP) is available to assist investigators in the manufacture of clinical products for phase I and phase II clinical trials, from drafting trial specific Standard Operating Procedures (SOPs), IND CMC preparation, validation services to the manufacture of clinical therapeutic products for clinical trials.

The staff has experience in the preparation of:

  • Hematopoietic Progenitor Cells
    • Bone Marrow
    • Peripheral Blood Stem Cells
    • CD34 Enriched Cells (Native & Transduced)
    • Donor Lymphocytes (Native & Transduced)
  • Antigen-Directed T cells
  • Antigen Presenting Cells

TCP Quality Control Laboratory Services

The TCP Quality Control (QC) Laboratory provides an extensive program of environmental monitoring for the clean rooms in addition to testing of in-process and release testing for cellular therapy products. The laboratory performs in-house testing, in addition to coordinating send-out testing to clinical and commercial laboratories, shown below:

  • Endotoxin – LAL
  • Mycoplasma – Mycoalert and FDA PTC
  • RODAC testing
  • Particle and Viable counts
  • Fallout plate testing
  • Blood Differentials

The TCP QC laboratory is also responsible for the storage and release of investigational cell therapy products, and for shipment of these products.