Survey finds solid base for early phase cell therapy manufacturing in UK
The survey of 22 different organizations with current spare GMP capacity found that of those surveyed, there is significant progress in establishing a wide variety of different manufacturing processes and product types, including gene modification, viral vector, and cell banking process experience, among others.
“The combination of world leading cell therapy research, the network of early phase clinical manufacturing centres and the large-scale manufacturing facility mean that the UK is well positioned within the global cell therapy industry,” the report says. “This situation will allow the growth of the industry within the UK and also the attraction of inward investment from outside of the UK.”
Only two of the sites surveyed -- the University of Oxford Clinical Biomanufacturing Facility and the UCL Royal Free Paul O’Gorman Laboratory -- were currently at their maximum capacity, but both have plans to expand in the future.
An additional cell therapy manufacturing site at the University of Birmingham Stem Cell Centre is also due to come online in 2014.
The survey gives a detailed breakdown of the analytical and processing equipment in each of the facilities, as well as how much capacity is available through 2017.
Late Phase, Commercial Capacity
In addition, the Cell Therapy Catapult has been awarded £55m ($93m) to design, build and establish a large-scale manufacturing centre that will be used for late phase manufacture and commercial supply.
A CTC spokeswoman previously told us that currently, there aren’t any manufacturing facilities capable of producing cell therapies in the volumes needed for late-stage clinical trials and the market.
The funding for this facility was announced in the 2014 UK budget and the plan is for it to be operational in 2017.
