LBG consultants Lauren R. Schoukroun-Barnes, Joseph Rininger, Kristi Sarno, and Susan Dexter interviewed CAR-T Innovators and Manufacturers to better understand the difficulties surrounding manufacturing. Specifically, the Innovators were asked about the criteria they look for in a CDMO.
Without exception, Innovator companies stated CDMO capacity and flexibility were top priorities. These criteria are priorities for Innovators because the drug product needs to be manufactured when the patient material is available. Ensuring Innovators can fulfill clinical development milestones is also a consideration with respect to CDMO capacity and flexibility. In determining who to use for a CDMO, there was no perfect solution, however early CDMO selection and scheduling are critical to maintain Innovators’ clinical development timeline.
CDMO selection was also based on a quality track record, validated manufacturing, and technical capability. Obtaining a CDMO with the proven ability to manufacture material in a compliant manner was key, as there limited CDMOs that can produce GMP CAR-T therapies. Technical capability in terms of process development is another attribute Innovators look for, since expertise for CAR-T manufacturing is limited. These selection criteria were followed by location and ability to scale-out. The site location was a priority to ensure that the facility was geographically close to the clinical sites. Ability to scale-out was also an important criterion, as Innovators indicated they want long-term partnerships and wish to avoid technology transfer of their processes amongst multiple CDMOs. This can take a significant amount of time, since each tech transfer requires a facility fit and verification of the process robustness. Thus, conducting extensive due diligence prior to CDMO selection is key to ensure a long-term relationship.
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