The contract manufacturing organisation (CMO), which has built a world-class reputation for clinical trial development and manufacturing, is building on these core capabilities with the announcement of an extension of these services.

 

The additional offerings, which include regular commercial supply for existing and new customers, will support full process validation for terminal sterilisation, aseptic filling and non-sterile manufacturing.

 

SCM Pharma has already secured a project with a UK firm for the ongoing autoclaving of a novel commercial product. The sterile fill/finish specialist has also picked up a long-term contract with a Western European firm for the aseptic processing and worldwide distribution of a licensed niche drug product.

 

Operating from its state-of-the-art MHRA-approved facility, the company’s flexible approach to scale adaptability and its technical expertise that allows it to deal with hazardous, difficult and unusual products gives the company a unique positioning within the global small-medium scale commercial supply market.

 

Shirley Dann, managing director at SCM Pharma, explains: “As we are able to handle short-run volumes, our commercial supply offering will appeal to companies in low volume markets or in niche markets such as orphan drugs and paediatrics.

 

“As with our clinical trial services, we can offer clients the technical knowledge and manufacturing expertise to deal with bespoke, complex and unusual products and processes, but on a commercial scale.

 

“We are able to offer genuine flexibility with regards to production scheduling and can also assist clients with scale-up, commercial launch and are able to adapt to future requirements to facilitate increased volumes” added Mrs Dann.

 

This latest launch follows a very promising year for SCM Pharma that has included the successful completion of its first project with Sanofi-aventis for the aseptic fill/finish of a radiolabelled product, just months after launching its radiopharma service at ICSE 2008. The company’s offering includes cGMP production of sterile radiolabelled products, both intravenous and in other dosage presentations.

 

SCM Pharma’s commercial arm now gives the company the capabilities and credentials to provide small-medium scale development and filling services for pre-clinical, Phase I-III clinical trials, scale-up, commercial launch and ongoing commercial supply.

 

Like its established sterile and non-sterile clinical trial supply offerings, all its commercial services can be delivered in a range of presentations including ampoules, vials, bottles, infusion bags and syringes for liquids, gels and powders.

 

SCM Pharma’s range of offerings complement its niche services that include biologicals, drug device combinations and its ability to handle cytotoxic products.

 

Working with top 20 pharma, small biotech firms and virtual companies, the CMO operates a centre for excellence and works with clients in the pharmaceutical, bio, medical device and healthcare sectors.

 

ENDS

 

Media contact:

Raman Sehgal

SCM Pharma

ramans@scm-pharma.com

01661 838 186