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).