Kincell to Manufacture Cell Therapy for Clinical Trials in New Partnership

• Kincell has entered a two-year contract to produce a formulated cell product for an undisclosed client's clinical trial, leveraging its Gainesville, Florida facility.
• The agreement encompasses technology transfer and GMP manufacturing, with Kincell aiming for a production rate of two to four doses per month for the client.
• This partnership marks one of several planned for Kincell's Gainesville facility, which is equipped with advanced infrastructure to support cell therapy manufacturing.
• Kincell continues to expand its CDMO capabilities through strategic partnerships and facility acquisitions to meet the growing demand for cell and gene therapies.

Kincell, a cell therapy contract development and manufacturing organization (CDMO), has announced a new partnership to produce a formulated cell product for an unnamed client's clinical trial. The two-year contract will utilize Kincell's facility in Gainesville, Florida, and includes technology transfer and clinical GMP manufacturing. The financial details of the partnership remain undisclosed.

Manufacturing Capabilities and Capacity

A Kincell spokesperson noted the Gainesville site's robust capabilities, highlighting its suitability for early clinical and Phase II studies. The facility is equipped with backup generators, uninterruptible power supply (UPS) support, and redundant equipment to support patient-specific manufacturing. Kincell aims to produce between two and four doses per month for the client, a typical output for an early-phase clinical trial.

Strategic Growth and Partnerships

According to the spokesperson, Kincell has plans for multiple partnerships at the Gainesville facility and has the capacity to support additional clients. Kincell Bio spun out of Inceptor Bio in August 2023 with $36 million in funding. In September 2023, Kincell partnered with eXmoor to address the increasing demand for cell and gene therapy (CGT) manufacturing in the US and Europe. Furthermore, in August 2024, Kincell partnered with Imugene to manufacture its allogeneic chimeric antigen receptor (CAR-T) candidate Azer-cel. Kincell also acquired a 32,000 square-foot manufacturing plant in Research Triangle Park (RTP) in North Carolina.