By Sanjin Zvonic, PhD, Director, Technology & Business Development
Let’s take a moment to focus on product delivery. In the context of CTPs, “delivery” is not a synonym for “shipping.” Delivery entails some (or all) of the following:
- QC release and shipping from the manufacturing site
- Receipt and storage at the clinical site
- Pre-administration processing at the clinical site
- Formulation and QC release at the clinical side
- Bedside administration at the clinical site
Every move of the cell product from the point of manufacture until it is administered to the patient is part of “delivery”.
Cell therapy products come in many varieties. The source may be allogeneic or autologous, with some allogeneic products being designed for universal use and some for patient-specific use. Cells may be in frozen or fresh form with storage required for frozen cells. Delivery can be a multi-step process or sometimes a direct process.
However, regardless of source or formulation, the vast majority of CTPs are clinically administered on a per-patient basis. A CTP will be clinically important, and therefore commercially viable, only if it is robust enough to be delivered to the patient in an efficient, controlled, and reproducible manner.
Clinical-end Convergence
Delivery affects clinical development. Delivery consistency directly affects product consistency, which has a significant impact on the quality of the clinical data describing product safety and efficacy. Also, delivery procedures requiring significant resources at the clinical site make it harder to engage clinicians and accrue patients in clinical trials.
Delivery also affects commercialization economics. The quality of the clinical data directly affects development timelines, resource requirements, and the ability to fund the development efforts. Impractical delivery procedures challenge the commercial product acceptance by both clinicians and patients. Furthermore demanding delivery resources increases the overall product cost, and cost affects healthcare acceptance and reimbursement.