Automated Cell Processing in Fully Closed Consumables
We integrated our understanding of the commercial and regulatory challenges our client faced, with our automation know-how, experience in developing consumables and our science and biology acumen, to develop a unique and commercially viable process.
- Automated cellular therapy production in fully closed consumables.
Cell therapy companies face many challenges when managing the journey from early clinical trials to commercial production. Apart from satisfying regulatory requirements and demonstrating that the therapy is efficacious and safe, commercializing such therapies also requires the therapy to be cost effective and scaleable. These requirements are particularly challenging where the therapy is manufactured in small batch sizes (eg specific to an individual patient such as autologous).
Traditional small volume cell processing is largely manual and only partially closed. Whilst arguably this approach is appropriate for research and early stage clinical trials, it introduces several significant commercialisation challenges including:
- Poor utilization of clean-room facilities
- Dependence on high-cost, high-skilled labor
- Processes are not readily scaleable
- Regulatory approval of early stage clinical trials based on a manual process may not be readily transferable to late stage clinical trials or commercial scale production using a different process
- Difficulties in satisfying quality requirements (cGMP) due to "open" processes and operator dependence
- The Process may not be readily transferable across multiple sites "the product is the process"
As a consequence, the cost of these therapies is often very high and achieving the reimbursable cost of therapy, almost unobtainable.
Our client engaged Invetech based on our breath of knowledge, expertise and our strong consultative approach.
By applying quality by design principals, we identified process failure modes, which in turn enabled our team to develop specific solutions to address the challenges revealed.
The solution developed was an automated process using closed consumables that allowed multiple patient samples to be processed in a single clean room.
The resultant automated cell processing system delivered a significant reduction in the cost of therapy, whilst making the therapy accessible to a larger patient population.
- A number of significant commercialization barriers were overcome including:
- Significant reduction in the risk of cross contamination by using a fully closed process
- Development of an automated process that reduced dependence on skilled operators and delivered process and product integrity
- Dramatic reduction in the investment required for facilities establishment and ongoing operations
- Fully integrated and validated process, enabling scale-up and scale-out to multiple locations