RoslinCT and Lykan Bioscience announce that the MHRA has granted an MIA License for their cGMP Manufacturing facilities in Edinburgh, UK
EDINBURGH, UK, and HOPKINTON, MA, 30 March 2023 – 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”.
ENDS
About RoslinCT
RoslinCT is a leading UK Cell Therapy Contract Development and Manufacturing Organisation (CDMO) focused on providing services for companies developing cell-based therapeutic products. Originally founded in 2006 as a spin-out from the Roslin Institute, RoslinCT expanded the broad range of scientific expertise available in the field of cell biology. Based at the Edinburgh BioQuarter, the company operates fully licensed GMP manufacturing facilities and has a proven track record in delivering cell-based products. For further information, please visit www.roslinct.com.
About Lykan Bioscience
Lykan Bioscience is an innovative contract development and manufacturing services organization (CDMO) focused on cell-based therapies. With decades of biopharmaceutical industry experience, Lykan offers a full range of development and manufacturing services. The state-of-the-art, purpose-built facility offering 14 independent manufacturing suites is uniquely designed to fully integrate cGMP principles and advanced software solutions to enable real-time testing, US/EU clinical and commercial manufacturing and release of product. Located in Hopkinton, Massachusetts, 25 miles southwest of downtown Boston and in the proximity of four international airports, Lykan Bioscience is ideally situated to deliver life-saving cell therapy treatments to patients on behalf of their partners. Visit www.lykanbio.com
For Media Enquiries
RoslinCT
Marketing Manager
Katerina Tsita
Lykan Bioscience
Director of Marketing
Carrie Zhang
