The CDMO has announced plans to add seven ISO Class 8 cGMP suites in the US
Lykan Bioscience, a contract development and manufacturing organisation (CDMO) focused on cell-based therapies, has announced plans to expand its state-of-the-art, purpose-built facility in Hopkinton, MA. The expansion is driven by the significant and growing demand for cell therapy process development and manufacturing.
Seven ISO Class 7 cGMP suites will be added to the existing facility with capabilities for both autologous and allogeneic production bringing the total number of clinical and commercial cGMP manufacturing suites to 15.
The laboratory will be completely modular
The seven new ISO 7 cGMP manufacturing suites will meet FDA regulatory guidelines for US clinical and commercial production; three of the suites will also meet EMEA guidelines for EU commercial production. All suites will be capable of supporting both autologous and allogeneic production and will be able to accommodate a wide range of manufacturing platforms. The expansion is expected to be commissioned and operational for partner programs by Q4 2022.
The 1,700 square foot laboratory will be located within the manufacturing facility, adjacent to cGMP processing suites and MS&T laboratories enhancing technology transfer.
The laboratory will be completely modular, will house industry advanced cell therapy processing and analytical technologies and will be staffed by experienced cell therapy process and analytical development scientists. The laboratory will be used in support of partner programs as well as for beta testing and co-developing innovative cell therapy manufacturing and analytical technologies. This laboratory expansion is expected to be commissioned and operational for customer projects by Q4 2021.
"Lykan is dedicated to providing innovative cell therapy production solutions and meeting our partners' process development and manufacturing needs," said Lykan President and CEO Patrick Lucy. "The funding support from our investors for this expansion will help us meet our partners' growing demand for capacity. Lykan is partner focused and patient driven, we believe the Lykan manufacturing facility sets the standard for cell therapy manufacturing, and we intend to maintain a world class facility and team to meet the future demands of the cell therapy industry."