French pharmaceutical company sanofi-aventis has again selected UK-based contract manufacturing organisation (CMO) SCM Pharma for the fast-tracked fill/finish of a radio-labelled product. Just a year after appointing the specialist manufacturer for the initial phase of the project, sanofi-aventis has opted to utilise the services of SCM Pharma for the aseptic manufacture and filling of a cytotoxic compound.
The potent oncology product will be filled into vials under aseptic conditions and then QP released at the CMO’s facility within just two months before being packaged at sanofi-aventis and distributed to clinical trial sites.
The project is being led by sanofi-aventis’ Analytical Sciences Department based in Alnwick.
SCM Pharma’s radiopharma supply service includes the cGMP production of sterile radiolabelled products, both intravenous and in other dosage presentations, from its MHRA-licensed site. Filling of the sanofi-aventis compound will be carried out using isolator technology within the CMO’s grade C (class 10,000) cleanroom.
‘This project highlights the strength of our niche offering in that we are able to provide a combination of specialist sterile filling services such as short-run radio-labelled, highly potent and non-live biological production for clinical trials and low volume licensed product supply,’ said Dianne Sharp, managing director at SCM Pharma.