Kincell announced that its facility in Gainesville, Florida will produce a formulated cell product for an unnamed client’s clinical trial.  

The two-year contract includes technology transfer and clinical GMP manufacturing. However, for a clinical trial, the contract duration depends on clinical enrollment rates and outcomes. The financials of the partnership have not been disclosed. 

A spokesperson for Kincell told BioProcess Insider that the production uses a proprietary process. “There are strong capabilities present at the Gainesville site. Our facility can support early clinical and Phase II studies, while our North Carolina, US facility can support early clinical through late stage registrational trials.” 

The CDMO aims to produce between two and four doses per month for the client, which is typical for an early phase clinical trial. Additionally, the Gainesville facility has been up-fit to include the necessary equipment and expertise to support requisite infrastructure elements such as back-up generators, uninterruptible power supply (UPS) support, and redundant equipment for patient-specific manufacturing, the firm said. 

“This partnership is one of many planned in the Gainesville facility. We have a number of ongoing conversations with potential partners, as well as available capacity within the existing facility to support several additional clients,” the spokesperson added. 

“Although our Gainesville facility was initially fit out to support cell-therapy manufacturing for an innovator biotech company, Inceptor Bio, we do not plan to do any of our own therapeutic development at Kincell. This allows us to remain focused on serving clients and building a highly operational third-party services organization.” 

Kincell Bio spun out of Inceptor Bio in August 2023 with $36 million in funding to help support research and clinical trials for cell-therapy developers. In September 2023, the firm partnered with fellow UK-based CDMO eXmoor to meet growing cell and gene therapy (CGT) demands for clients in the US and Europe.  

Moreover, the CDMO partnered with Imugene in August 2024 to produce its allogeneic chimeric antigen receptor (CAR-T) candidate Azer-cel. In addition to this partnership, Kincell acquired a 32,000 square-foot manufacturing plant in Research Triangle Park (RTP) in North Carolina.