To be housed in the new science complex at the University of Sunderland
Dianne Sharp says launching its formulation development capability will be a huge milestone for SCM Pharma
UK-based SCM Pharma is to launch its own formulation development capability after acquiring new facilities as part of a collaborative deal with the University of Sunderland.
The development and contract manufacturing organisation (CDMO) will use ICSE at CPhI in Frankfurt and AAPS in Washington DC in October as the global platforms to showcase its new in-house service offerings.
The move follows a two-year development project with Mitovie Pharma, based at Clayton-Le-Moors, Lancashire, UK, to assist the specialist drug developer with formulation support for one of its four leading drug candidates. The pharmacuetical firm is formulating a single-use product, which is intended for use in accidental overdose.
Mitovie Pharma’s chief executive Michael Hawthorne said: ‘Like SCM Pharma, we generally deal with more complex and challenging products. This is why we have been working closely with its team to help fast track the development of one of our key products.
‘The knowledge acquired by SCM Pharma during this formulation process will be vital in helping us quickly tech transfer our product into clinical trials manufacturing within its cGMP production facility.’
SCM Pharma’s pre-clinical capability will be housed in formulation and analytical laboratories at the University of Sunderland’s new £8.5m science complex based near the clinical trial manufacturer’s MHRA-licensed facility. SCM Pharma believes the service will naturally complement its established clinical trial product supply capabilities.
SCM Pharma will initially provide developmental services for liquid formulations including emulsions and suspensions for parenteral, oral and topical administration using either proprietary or customers’ delivery systems. Stability and analytical testing support services will also be provided along with the capability to provide GMP formulation if required.
SCM Pharma’s managing director Dianne Sharp said: ‘This is a huge milestone for our business. The work we have carried out with Mitovie has provided us with an ideal grounding of what to expect when introducing, managing and progressing such projects.
‘And by utilising the fantastic research facility at the University of Sunderland, our new dedicated facilities and expertise only strengthen our proposition of being able to hit the ground running with clients’ formulation development requirements.’