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Sanofi Tabs SCM for Aseptic Filling of Radiolabelled Compound

PharmaManufacturing.com
05/19/2009

UK-based contract manufacturing organization (CMO) SCM Pharma has picked up its first project with Sanofi-aventis for the fill/finish of a radiolabelled product.

The oncology product will be filled under aseptic conditions and then released at SCM Pharma’s Northumberland-based facility before being packaged at Sanofi-aventis and sent to clinical trial sites in Europe.

The project is expected to last around three months and includes initial work by the specialist CMO to validate the process sterility before commencing full aseptic production.

This is SCM Pharma’s latest radiolabelled project-win after launching its radiopharma service at the end of last year. The company’s offering includes cGMP production of sterile radiolabelled products, both intravenous and other in-dosage presentations, from its MHRA- and Environment Agency-approved site.

The project is being led by Sanofi-aventis’ Analytical Sciences Department based in Alnwick. Head of production at Sanofi-aventis said: “We have been aware of SCM Pharma for a while and have kept a close eye on the company’s progress and new service offerings.

“Due to the nature of this product, we required a specialist manufacturing partner, ideally in the UK. Given SCM Pharma’s ability to handle radiolabelled compounds under aseptic conditions, it seemed the ideal opportunity to work with them to help us deliver this key stage of the overall project.”

The fill/finish activity is part of a larger Phase III project being carried out by Sanofi-aventis. Production will be carried out using isolator technology within SCM Pharma’s grade C (class 10,000) cleanroom.

Shirley Dann, managing director at SCM Pharma, said: “We are very pleased to be working with Sanofi-aventis on such an innovative project. The requirements fit very well with our strengths of handling radiolabelled compounds and utilizing 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,” added Shirley.

SCM Pharma’s radiopharma service assists companies at both pre-clinical and clinical stages of development by offering compounding, handling and­ filling services for radiolabelled materials. The technique can reduce the cost of developing new drugs by helping bring them to market over a shorter timescale. It can also offer valuable information on how a product is metabolized in the human body.