Patients Are Waiting: Commercial CAR-T Facility Design To CQV

By Tom Piombino, Managing Director Americas, Integrated Project Services, LLC

When it comes to difficult-to-treat cancers, the cell therapies pioneered in recent years to offer more targeted treatments have emerged as game changers for certain rare and intractable malignancies. Some of the most promising modalities in the space today are CAR-T therapies, T cells that have been modified to produce chimeric antigen receptors (CARs) on their surface, allowing them to target specific antigens on cancer cells.

As more and more CAR-T therapies achieve commercial success, the current scarcity of specialized manufacturing capacity will only serve to stall production scale-up for these crucial modalities. For many of the companies pursuing these therapies, broader indications and larger patient populations will require them to construct manufacturing facilities to meet unprecedented demand. Furthermore, because these therapies are manufactured autologously, understanding the space, staffing, containment, GMP, and quality control considerations necessary to achieving a successful large-scale operation can be a complex undertaking.

Finding a creative partner that can shape the design, build, and validation of a CAR-T manufacturing facility comprehensively can help companies avoid costly operational missteps and leverage consolidated, diverse expertise from a single source. The result is a facility positioned to produce therapies quickly and compliantly, at volumes necessary to meet the growing and evolving needs of the patient populations these modalities reach.