Lykan Bioscience to Increase Its Cell Therapy Process Development and Manufacturing Capacity by 90%
Lykan Bioscience, a contract development and manufacturing organisation specialising in cell-based therapeutics, announced the expansion of its facility in Hopkinton, Massachusetts. The increasing need for cell therapy process research and production is driving the expansion and establishment of new innovation lab.
As part of the facility expansion plan, seven ISO 7 cGMP suites with autologous and allogeneic production capabilities will be added to the current facility, bringing the total of clinical and commercial cGMP manufacturing suites to 15.
The seven new ISO 7 cGMP manufacturing suites will comply with FDA regulations for clinical and commercial production in the United States; three of the suites will also comply with EMEA regulations for commercial production in the European Union. All suites will manage both autologous and allogeneic production, as well as a variety of manufacturing platforms. The expansion should be up and running for partner programmes by end of 2022.
Process and Analytical Development capabilities will be expanded by 1,700 square feet to support partner initiatives and CMC innovation, reported by Lykan Biosciences. The laboratory will be housed within the production plant, next to cGMP processing suites and MS&T labs, allowing for better technology transfer. The laboratory will be housed within the production plant, next to cGMP processing suites and MS&T labs, allowing for better technology transfer. The laboratory will be completely modular, feature advanced cell therapy processing and analytical technology, and be managed by experienced cell therapy staff. The lab will support partner initiatives, beta development and co-development of analytical technologies. By Q4 2021, the laboratory extension should be commissioned and ready for customer projects.
Article Lykan Biosciences
Lykan Bioscience provides innovative cell therapy production solutions to support their partners with process development and manufacturing needs. Its manufacturing facility offers eight independent manufacturing suites which are designed to fully integrate cGMP principles and advanced software solutions to enable real-time testing and release of product.