08.11.10
Sanofi-Aventis has selected SCM Pharma for the fast-tracked fill/finish of a radio-labelled product. SCM will provide services for the aseptic manufacture and filling of a cytotoxic oncology compound into vials. The product will then be packaged at Sanofi and distributed to clinical trial sites. SCM worked with Sanofi on the initial phase of the project.
A Sanofi-Aventis representative commented, “We were very impressed with the manner and speed in which SCM Pharma was able to deliver the project last year. The team showed great willingness to meet the tight deadline and was able to come up with solutions to solve the challenging production requirements. We are looking forward to working with the team again and expect they will once again deliver the product in time for our scheduled Phase III clinical trials.”
Dianne Sharp, managing director at SCM Pharma, said, “We are delighted to be working with Sanofi-Aventis again as it strongly suggests we are delivering to a high enough standard that reputable clients are willing to return and build a long-term relationship. 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.”
SCM Pharma’s radiopharma supply service includes the cGMP production of sterile radiolabelled products, both intravenous and other dosage forms, from its MHRA-licensed site. Filling of the Sanofi-Aventis compound will be carried out using isolator technology within SCM’s grade C (class 10,000) cleanroom.
A Sanofi-Aventis representative commented, “We were very impressed with the manner and speed in which SCM Pharma was able to deliver the project last year. The team showed great willingness to meet the tight deadline and was able to come up with solutions to solve the challenging production requirements. We are looking forward to working with the team again and expect they will once again deliver the product in time for our scheduled Phase III clinical trials.”
Dianne Sharp, managing director at SCM Pharma, said, “We are delighted to be working with Sanofi-Aventis again as it strongly suggests we are delivering to a high enough standard that reputable clients are willing to return and build a long-term relationship. 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.”
SCM Pharma’s radiopharma supply service includes the cGMP production of sterile radiolabelled products, both intravenous and other dosage forms, from its MHRA-licensed site. Filling of the Sanofi-Aventis compound will be carried out using isolator technology within SCM’s grade C (class 10,000) cleanroom.