The combined group will offer process development expertise and cGMP manufacturing for a broad range of autologous and allogeneic cell therapies, with ‘unparalleled expertise’ in gene editing and industry-leading induced Pluripotent Stem Cell (iPSC) capabilities.
In particular, the group will benefit from significantly expanded capacity: with process and analytical development laboratories and cGMP manufacturing facilities in Edinburgh, Scotland, and in Hopkinton, Massachusetts.
Combining manufacturing capacity
As a CDMO focused on cell-based therapies, Lykan has a 64,000 sq. ft. cell therapy manufacturing facility and innovation/development laboratories, with 16 cGMP processing suites to be running by the end of 2022.
Further laboratory and cGMP capacity expansion in Scotland is planned to build on cell and gene therapy specialist RoslinCT’s existing 40,000 sq. ft facilities, including 8 cGMP suites.
The two companies note that demand for high-quality development and manufacturing capacity is increasing across the world: adding that its combination can shorten development and manufacturing timelines for advanced therapy sponsors.
This is thanks to GMP manufacturing capability that stretches all the way from clinical through commercial, meaning there is no need for a tech transfer to a commercial CDMO during the project, the companies told us.
The combined expertise also means the newly formed group is better placed to serve development challenges (for example, the RoslinCT iPSC platform and expertise can be leveraged to accelerate development timelines).
And with a manufacturing footprint on both sides of the Atlantic, this can bring manufacturing closer to the patient without the need to bring in other CDMOs.
Commercial GMP manufacture
Asked what the main strength of the new combined company will be, the group highlights its ability to partner with sponsors to take a therapeutic all the way from development through to commercial manufacture.
Both businesses are set up for commercial GMP manufacture: and while neither currently manufacture any commercialized product, they expect to begin this next year on the back of a successful clinical trial run by RoslinCT with a long-term undisclosed customer.
Workforce of 300 employees
RoslinCT CEO Peter Coleman and Lykan President & CEO Patrick Lucy will remain in their current roles: leading a combined global workforce of 300 employees.
Peter Coleman, CEO of RoslinCT said: “This combination puts us in a strong position as a leading global CDMO in the process development and manufacturing of advanced cell therapies, and we look forward to working with our new colleagues at Lykan to fuel future growth and meet the increasing demand for innovative therapies.”
Patrick Lucy, President & CEO of Lykan Bioscience, added: “We are delighted to combine with RoslinCT to better serve the growing demand for manufacturing capacity and expand the range of innovative services we can provide our partners to support the development of advanced cell and gene therapies.”
Global Healthcare Opportunities, a European specialist investor in global healthcare, announced its investment in RoslinCT earlier this year. As part of the business combination, GHO is making a majority investment in Lykan and is backing the funding of the combined entity.
WindRose Health Investors, previously the majority owner of Lykan Bioscience, has reinvested in the new combined group along with Lykan Management.