Clinical Cell Therapy Support

KBI provides patient sample collection and product delivery with validated shippers as well as regulatory support. We have experience successfully managing manufacturing materials with centralized receipt and supply of patient materials to facilities across North America.

KBI's clinical cell therapy support includes:

  • Patient sample collection, product delivery and coordination
    • The facility has previously delivered >1500 doses to 35 clinics
  • Tracking of incoming, in process, and outgoing clinical trial materials
  • Controlled temperature specimen transport using Qualified and Validated Shippers
    • Room temperature, refrigerated, and frozen
  • Regulatory support including IND and CMC filings
  • Therapeutic Monitoring of a patient’s response to product on study