Results
Charles River Laboratories International Inc.
05/08/2024 | News release | Distributed by Public on 05/08/2024 08:46
Successfully Scale T Cell Products with Fill Finish Strategies
As cell therapy developers know, the final steps of formulation and fill finish for T cell products can be complex and challenging, especially with therapies that require sets of multiple product bags.
This manual process is often not only labor intensive, but reproducibility can prove difficult with variation occurring in both volume and quality in the final product, which can cause delays and increase costs during the critical final steps of cell therapy manufacturing.
To scale up the formulation and fill finish steps while improving bag integrity, we collaborated with Terumo Blood and Cell Technologies by testing their FINIA® platform to automate and expand the fill finish of autologous T cell therapies.
Achieving Consistency in Fill and Finish for Autologous Therapies
Find out how you can achieve consistency and reduce risks to ensure scale-out strategies for multiple bag requirements and post-thaw viability of T cell therapies in a closed environment.
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Improving Time to Market
After completing the test as part of the cell and gene therapy workflow, data showed our team could increase the volume of the T cell therapy while maintaining the quality attributes of the product.
The FINIA system was able to process larger than normal volumes, exceeding 304 mL into total 16 bags, including 12 product bag and 4 QC bags - a fourfold increase in capacity in just two hours as compared with its singular capacity.
The automated system also produced accurate volumes of T cell product across all containers with less than 5% variability. Furthermore, the test showed limited impact to cell viability, maintaining both the phenotype and functionality of the product. Overall, this automation reduced operator hands-on time by 60%.
Finally, FINIA can extend bag viability by controlling temperature for both inputs and final product, and by limiting cell exposure to the toxic cryoprotectant DMSO.
As the development of cell therapies continues to grow, demonstrating that this automated, scalable approach to fill finish can maintain product uniformity and quality is a critical step. For more information on our cell and gene therapy manufacturing services and products, visit our Cell and Gene Therapy CDMO Solutions page.