White Paper |
By Gary M. Pigeau, Elizabeth Csaszar, and Aaron Dulgar-Tulloch,CCRM
Allogeneic cell therapy products are generating encouraging clinical and preclinical results. Many of these therapies are also expected to have large market sizes and require cell doses of ≥109 cells. As therapeutic technologies mature it is essential for the cell manufacturing industry to correspondingly develop to adequately support commercial-scale production. To that end, there is much that can be learned and adapted from traditional manufacturing fields. In this review, we highlight key areas of allogeneic cell therapy manufacturing, identify current gaps, and discuss strategies for integrating new solutions.
White Paper |
By Tom Piombino and Sue Behrens,IPS-Integrated Project Services
The movement of viral vectors, cell therapies, and other antibody-based next-generation drug products toward commercialization is driving the need for new and different technologies and facilities. Engineering and design firms with the right skillsets can help you maintain the right balance in your facility design to maintain flexibility, which is essential to meet diverse processing needs for biopharmaceutical manufacturing.
Selecting a safe starting dose must be balanced against the proportion of patients treated at subtherapeutic doses. This is especially important for agents that demonstrate minimal toxicity in preclinical testing or for drugs that are unlikely to ever reach maximum tolerated dose. This approach has the potential to reduce the number of dose escalations while preventing patients from being treated at overly toxic doses that lack incremental biological activity.
Reduced input variability and careful selection of freezing and thawing rates are critical in T-cell processing. Backed by science and data, our experts examine how control of these factors can influence and optimize mononuclear cell enrichment and cryopreservation.