Scaling Your CAR-T Operation: A Guide For The Life Sciences Leader

Cell therapies pioneered in recent years to offer more targeted treatments have emerged as game changers for certain rare and intractable malignancies. Among the most promising modalities in the space today are CAR-T therapies. These involve T cells that have been modified to produce chimeric antigen receptors (CARs) on their surface, enabling them to target specific antigens on cancer cells.

With an increasing number of CAR-T therapies attaining commercial viability, the current scarcity of specialized manufacturing capacity will only hinder production scale-up for these crucial modalities. Many of the companies pursuing these therapies will find themselves needing to construct manufacturing facilities to address the unprecedented demand due to broader indications and larger patient populations. Furthermore, because these therapies are manufactured autologously, understanding the space, staffing, containment, GMPs, and quality control considerations required to achieve a successful large-scale operation can be a complex undertaking.

Identifying a creative partner capable of shaping the complete process of designing, constructing, and validating a CAR-T manufacturing facility can help companies avoid costly operational errors and leverage expertise from a single source. The result is a facility positioned to swiftly and compliantly produce therapies at the volumes necessary to meet the growing and evolving needs of the patient populations these modalities reach.