Establishing the production unit gives Cancer Research UK the capacity to support scientists as they transition compounds from the laboratory to the clinic. Cancer Research UK began work on the plant in 2007 and the first product manufactured at the site has now entered clinical trials.
The product, an antibody called Chi Lob 7/4, was discovered at the University of Southampton, UK. A Phase I clinical trial, using material produced at the new site in Hertfordshire, UK, is now treating patients who are no longer responding to conventional treatment.
Peter Johnson, the trial’s lead, said: “Having experimental medicines readily available from our own medicine manufacturing centre will be an enormous boost to clinical trials such as this one which is testing a promising new antibody to treat people with cancer.”
Operating the unit will allow Cancer Research UK to be more cost-effective and efficient when producing clinical trial materials. This makes better use of its resources and helps accelerate the passage of treatments into clinical trials.
Cancer Research UK has equipped the unit to produce biologics, such as monoclonal antibodies, plasmid DNA and recombinant proteins. Housed at the plant are a 30L continuous fermenter and 100L spinners, as well as downstream processing, cell banking and vial filling capabilities.
The unit is compliant with current good manufacturing practices (cGMP) and licensed by the UK Medicines and Healthcare Regulatory Authority (MHRA) for the manufacture of investigational medicinal products (IMPs).
These capabilities complement Cancer Research UK’s other manufacturing plant in Glasgow. The Glasgow unit, at the University of Strathclyde, develops and manufactures parenteral and oral sold-dose forms for use in clinical trials.