Blog | 7/30/2024
Innovation in Cell Therapy Manufacturing: Decentralized Approaches and Beyond
By Shay Pezzulo, Alicia Shields, PhD, Ned Wydysh, PhD, and Vivek Mittal, PhD
Given the well-known logistical challenges associated with cell therapy manufacturing processes today, it is unsurprising that many companies are turning toward more innovative strategies like decentralization.
Belgium-based biotech Galapagos, for example, has been ramping up its decentralized CAR-T manufacturing network in order to meet its goal of reducing the time from cell collection to infusion to seven days. Earlier this year, Galapagos announced a partnership with Blood Centers of America (BCA) to help facilitate technology transfer across multiple sites simultaneously, enabling the manufacturing of its CAR-T therapies in closer proximity to key cancer treatment centers. Access to BCA's expansive apheresis capabilities will also address a longstanding bottleneck in CAR-T therapy production by helping to streamline the initial stages of treatment preparation.
Novel Approaches to End-to-End Manufacturing
In addition to decentralization, companies are increasingly adopting innovative end-to-end manufacturing processes, which can complement decentralized operations by enhancing efficiency and scalability. Miltenyi’s CliniMACS Prodigy, an automated cell processing platform that enables scalable point-of-care manufacturing of cell therapies, serves as a key example. The Prodigy integrates all steps in the cell therapy manufacturing workflow from cell isolation, activation, genetic modification, and cell expansion to harvesting of the final cell product. Its use in the clinic for decentralized manufacturing of cell therapies decreases processing times through reductions in the amount of labeling, tracking, and documentation needed for patient samples.
Others exploring novel automated approaches include Bristol Myers Squibb, which recently announced a $380MM deal with Cellares to utilize its next generation end-to-end cell therapy manufacturing network featuring fully automated “Smart Factories.” Kite, which has already partnered with Cytiva to roll out its own automated end-to-end cell therapy manufacturing system, is also evaluating the potential of working with Cellares. Ori Biotech is another player making strides in the space, having recently announced its IRO platform, which is similarly designed to automate, digitize, and accelerate cell therapy development.
Broader Considerations & Implications
Decentralized manufacturing is certainly not without its own drawbacks and may not be the best fit for all programs. Companies must weigh the benefits of improving lead time and patient access with the potential quality issues and cost increases that may arise. Of course, such a cost-benefit analysis will depend heavily on each product’s expected patient volume, pricing potential, and personalization requirements. The company’s financial resources and tolerance for risk will also likely serve as key considerations. In the same vein, some larger players have more established processes with expensive infrastructure that are difficult to completely uproot. Decentralization is also not the only solution to turnaround time challenges and other inefficiencies, with automated end-to-end platforms showing potential with and without use alongside a decentralized approach. Though decentralized manufacturing presents promise within the cell therapy space, the extent to which it will be effectively utilized over more centralized processes remains to be seen.
Author Bios
Shay Pezzulo is a Senior Analyst within the Health Advances Cell and Gene Therapy Practice.
Alicia Shields, PhD is a Consultant and team leader within the Health Advances Cell and Gene Therapy Practice.
Ned Wydysh, PhD is a Vice President and co-leader of Health Advances’ Oncology and Cell and Gene Therapy Practices.
Vivek Mittal, PhD is a Partner, Managing Director, and co-leader of Health Advances’ Oncology and Cell and Gene Therapy Practices.
References
https://endpts.com/ori-biotech-cytiva-separately-unveil-tech-to-accelerate-cell-therapy-production/
https://www.miltenyibiotec.com/
https://www.miltenyibiotec.com/US-en/applications/by-cell-type/t-cells/CAR-T-cell-manufacturing.html