HOPKINTON, Mass., November 9, 2021 / PRNewswire / – Lykan Bioscience, an innovative contract development and manufacturing (CDMO) organization focused on cell-based therapies, today announced plans to expand its state-of-the-art facility by Hopkinton, MA. The expansion is driven by the large and growing demand for the development and manufacture of cell therapy processes.
- Seven ISO 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
- Expansion to include an addition of 1,700 square feet to process development and analytics capabilities supporting partner and CMC programs innovation
The seven new ISO 7 cGMP manufacturing suites will meet FDA regulatory guidelines for clinical and commercial production in the United States; three of the suites will also meet EMEA guidelines for EU commercial production. All suites will be able to support 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 lab will be located in the manufacturing facility, adjacent to cGMP processing suites and MS&T labs enhancing technology transfer. The laboratory will be fully modular, house advanced cell therapy processing and analytical technologies, and will be staffed with scientists experienced in cell therapy process and analytical development. The laboratory will be used to support partner programs as well as for beta testing and co-development of innovative cell therapy manufacturing and analysis technologies. This extension of the laboratory should be commissioned and operational for customer projects by the fourth quarter of 2021.
âLykan is dedicated to providing innovative cell therapy production solutions and meeting the process development and manufacturing needs of our partners,â said Lykan President and CEO. Patrick Lucie. âFinancial support from our investors for this expansion will help us meet the growing demand for capacity from our partners. Lykan is partner-oriented and patient-focused, we believe Lykan’s manufacturing facility sets the standard for cell therapy manufacturing, and we intend to maintain a world-class facility and team for meet the future demands of the cell therapy industry. “
About Lykan Bioscience
Lykan Bioscience is an innovative contract development and manufacturing services (CDMO) organization focused on cell therapy. With decades of experience in the biopharmaceutical industry, Lykan offers a full range of development and manufacturing services. The state-of-the-art, purpose-built facility offering eight independent manufacturing suites is uniquely designed to fully integrate cGMP principles and advanced software solutions to enable real-time product testing and release. Situated in Hopkinton, Massachusetts, 25 miles southwest of downtown Boston and close to four international airports, Lykan Bioscience is ideally located to provide life-saving cell therapy treatments to patients on behalf of their partners. Visit www.lykanbio.com
SOURCE Lykan Bioscience