Catalent has designed a case management service, which aims to tackle challenges associated with the safety and timeline of cell and gene therapy programs.

Contract development manufacturing organization (CDMO) Catalent says the complex nature associated with delivering doses of cell and gene therapies (CGTs) means the products need to be managed correctly and efficiently to reduce the risk of production schedule disruption and administration of the therapy to the individual.

The launch of the company’s case management service looks to provide the customer with “peace of mind” by minimizing the chance of program problems and ensuring successful delivery of the therapy to the patient. To do this, Catalent will offer supply chain oversight across the entire program lifecycle.

DepositPhotos/iqoncept

“The experience Catalent has in supply logistics has allowed it to design this new service so that it can be scaled to meet a wide range of customer program needs from small biotech to mid/large pharma, as the number of therapies in development increases,” Trisha Demko, director, Case Management Services at Catalent told BioProcess Insider.

Clients who decide to use the service will be assigned a case manager. The case manager will then act as a point of contacting from the start of the program through to the end, regardless of whether the therapy is being produced by Catalent or another firm.

The case manager will be responsible for coordinating the material collection schedule, arranging shipments, monitoring the shipping status, and looking after the manufacturing slots for the therapy. In addition to this the manager will coordinate documentation and traceability, as well as ensuring chain of custody and identity are maintained throughout the product lifecycle.

“Catalent has already built a team of case managers who have specialist expertise in managing complex cell and gene therapy supply chains, whether it’s accommodating the short vein-to-vein time for cell therapy, or the unique cold chain needs of these complex therapies,” said Demko.

“These case managers focus exclusively on the delivery of these services and have the resources to meet the needs of our current and forecasted demand. We expect to grow the team as customer demand increases so that an appropriate case manager-to-project ratio is maintained.”

According to the CDMO, the service is global and while the current case managers are based in the US, they “work on a staggered, on-call schedule to ensure 24/7 support is available when and where needed. Future expansions of the Case Management team could include adding staff based outside of the US, with Europe being a potential for localized support in the region.”

If a customer selects to manufacture their product with a third party but still wants to use Catalent’s case manager service, then the case worker assigned to the program will work as “an intermediary to coordinate the shipping and logistics of materials with the scheduling of the manufacturing slot(s) at the site,” Demko told us.

On the other hand, customers that choose Catalent to manufacture their therapies will be given access to its CGT production network. This includes gene therapy manufacturing sites located in Baltimore and Harmans, Maryland, an induced pluripotent stem cell (iPSC) development and differentiation facility in Dϋsseldorf, Germany, and cell therapy production plants in both Princeton, New Jersey and Gosselies, Belgium.