09 August 2010
FRENCH pharmaceutical company sanofi-aventis has once again selected contract manufacturing organisation (CMO) SCM Pharma for the fast-tracked fill/finish of a radio-labelled product.
Just a year after appointing the UK-based specialist manufacturer for the initial phase of the project, the world’s second biggest pharmaceutical firm 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. Head of production at sanofi-aventis said: “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.
“Based on its performance, we had no hesitation in approaching and appointing SCM Pharma with another project. 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.”
SCM Pharma’s radiopharma supply service includes the cGMP production of sterile radiolabelled products, both intravenous and other in 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.
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 in particular 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,” added Dianne.
The announcement of this agreement with one of the world’s top pharmaceutical companies comes hot on the heels of news of SCM Pharma picking up several new contracts, including its first US-based client. With an emphasis on manufacturing novel, difficult and dangerous drug products, it now offers its sterile and non-sterile production services to pharmaceutical, biotech and medical device companies worldwide.
The company has worked with a third of the top ten big pharma and on various product indications across a number of therapeutic areas including cancer, rheumatoid arthritis, epilepsy, dermatitis, needle-free injection technology and sexual health.
ENDS
Picture caption: ASEPTIC: SCM to GMP sterile fill/finish a radio-labelled product for sanofi-aventis
Media contact: Raman Sehgal at SCM Pharma
01661 838 186 / ramans@scm-pharma.com
