A 17,000 sq ft (1,600 sq. m) high-specification lab space is currently under construction - it is located in a UK life sciences hub in Alderley Park, Cheshire and is scheduled to be finalized by this summer.
The company is investing £7m (US$9.2m) in the UK expansion project: that includes capital and equipment, construction costs, and fees.
The enhancement will quadruple Charles River’s manufacturing capacity for plasmid DNA, a critical starting material for immune-oncology and CRISPR based therapies.
“This expansion at Alderley Park is focused on our HQ plasmid offering and significantly increases our existing capacity to meet global demand,” Nick Smith, Alderley Park Site director, Charles River, told BioPharma-Reporter.
The HQ plasmid services will include critical features of CGMP manufacturing, and will have a six-week turnaround time.
“We have a track record of providing our clients with plasmids to fit their specific needs,” commented Smith.
HQ plasmid is typically used in toxicology studies, for GMP vector production (Phase I-II), or as a template for GMP mRNA, while research grade plasmid is used for in vitro R&D or pre-clinical studies, and GMP plasmid is used in Phase I-III and commercial viral vector and DNA vaccine programs.
The new site, which will serve Charles River’s global customer base, allows for 11 additional suites offering multiple independent processing streams and dedicated areas for product fill finish activities. Complementary capabilities will include quality control labs for onsite monitoring and release, said the company.
The expansion follows Charles River’s acquisition of Keele, England-based Cobra Biologics, a plasmid DNA and viral vector cell and gene therapy contract development and manufacturing organisation (CDMO), in March 2021 and will see an additional 50 new positions created, from apprentices through to experienced scientists.
Home to over 250 companies, the Alderley Park life sciences and biotech cluster also includes the Cancer Research UK Manchester Institute as well as global cell therapy business Instil Bio, and precision medicine businesses Kinomica and Sutura Therapeutics.
