The unique need of developing advanced therapies stems from their unique development processes. For autologous therapies, the biological material is collected by Apheresis. Collected cells are shipped to the manufacturing site for genetic modification and manipulation under laboratory conditions. Once ready, the customized therapy is shipped back to be administered to the patient.
A similar process is followed for allogeneic therapies as well, where the cells are modified, grown, and processed to develop the final medicinal product.
Conventional supply chain models are proving insufficient to meet the emerging needs of the cell and gene therapy industry for optimal management and delivery of mission-critical milestones including:
- Shipping under stringent temperature
- Meeting strict timelines
- Assuring chain of identity (COI) and chain of custody (COC)
With globalization, global pandemics, natural disasters, political and economic factors contributing to the difficulties in receiving quality material and delivering therapies in a safe, timely and efficient manner, supply chain challenges are being put in the spotlight.
In this whitepaper, we will discuss about:
- Supplier challenges faced by CGT developers
- How to qualify and onboard suppliers
- Enabling a risk-based approach
- And more