The deal is the first SCM has signed with Sanofi and is a boost for the contract manufacturing organisation’s (CMO) radiopharma service that it launched towards the end of 2008.
For the project Sanofi was seeking a specialist manufacturing partner, ideally in the UK, that could handle radiolabelled compounds. Sanofi has monitored SCM’s progress and believes that the CMO’s ability to meet these criteria made the oncology project the ideal opportunity for the companies to work together.
Expanding on this, Shirley Dann, managing director at SCM Pharma, said: “The requirements fit very well with our strengths of handling radiolabelled compounds and utilising our aseptic processing capability.
“This is the latest of several high-profile pharmaceutical companies we are working with and is very encouraging for the business in terms of confirming our unique offering of difficult, short-medium run and specialist services in the market.”
The project is using isolator technology within SCM’s grade C (class 10,000) cleanroom and is due to last for three months, with some of this time being used to validate process sterility before commencing full aseptic production.
Sanofi will package the product and send it to clinical trial sites throughout Europe.
SCM’s radiopharma capacity
SCM has two facilities in Northumberland, UK and from these offers current good manufacturing practice (cGMP) compliant production of sterile radiolabelled products for preclinical or clinical use.
The site can handle intravenous and other dosage forms and has been approved by the European Medicines Agency (EMEA) and Medicines and Healthcare products Regulatory Agency (MHRA).
In addition SCM can handle cytotoxic and cytostatic products, offers clinical packaging services and aseptic processing of biologics.