ROSLINCT and Lykan Bioscience, leaders in ground-breaking Contract Development and Manufacturing for cell therapies, are delighted to announce that following a successful inspection at their Edinburgh, UK facility, from the Medicines and Healthcare products Regulatory Agency (MHRA), a Manufacturer’s Authorisation Licence (MIA) for commercial manufacturing of cell therapy products has been granted.
Completed in late 2021, RoslinCT’s newest 1,600 square-meter state-of-the-art facility, located in Edinburgh’s BioQuarter, was designed to operate as a flexible and scalable manufacturing hub, housing five cGMP clean rooms and a dedicated training laboratory. The cGMP facility has been designed and purpose-built specifically to accommodate cell therapy manufacturing processes for both allogeneic and autologous therapies with or without genome editing requirements.
The license granted by the UK’s regulatory body will allow RoslinCT and Lykan Bioscience, who are currently working with their partners to develop and manufacture cutting edge life-changing therapies and cures for patients suffering from some of the most debilitating medical conditions, to expand their service offering to produce market-approved cell therapy products.
Peter Coleman, Chief Executive Officer of RoslinCT said: “At RoslinCT we thrive on being pioneers in our sector, accelerating the delivery of these novel life-changing therapies to patients. The MIA commercial manufacturing licence is a huge landmark in the history of RoslinCT and is testament to the relationship we have developed with the MHRA and the hard work of our team. We will continue to work with our partners to deliver these life-saving therapies to patients”.
Patrick Lucy, President & Chief Executive Officer of Lykan Bioscience, commented: “This license is a significant milestone for RoslinCT, Lykan Bioscience and our partners. Empowering our partners to progress efficiently from development to commercialization and deliver life-saving cell therapies to patients worldwide is at the core of our mission. The learnings acquired by RoslinCT that ultimately resulted in the receipt of the commercial manufacturing license will be invaluable as we align our global manufacturing operations”.
