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 by SCM Pharma follows a two year development project with Mitovie Pharma to assist the speciality drug developer with formulation support for one of its four lead candidates. The pharmacuetical firm is formulating a single use product, which is intended for use in accidental overdose.
Michael Hawthorne, CEO at Mitovie Pharma, said: "Like SCM Pharma, we generally deal with more complex and challenging products. This is why we have been working closely with their 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 their cGMP production facility."
SCM Pharma’s pre-clinical capability will be housed in state-of-the-art formulation and analytical laboratories at the University of Sunderland’s new £8.5m science complex based near to the clinical trial manufacture’s existing MHRA-licensed facility. The service is seen as one that will naturally complement the sterile manufacturing expert’s established clinical trial product supply capabilities.
Initially, the CDMO will provide developmental services for liquid formulations including emulsions and suspensions for parenteral, oral and topical administration using either proprietary or customers’ novel delivery systems. Stability and analytical testing support services will also be provided along with the capability to provide GMP formulation if required.
Dianne Sharp, managing director at SCM Pharma, said: "This is a huge milestone for our business and what better stages than ICSE and AAPS to simultaneously launch this core new service to the European and North American markets.
"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.
"With our track record of consistently supplying products for clinical trials and niche commercial markets, we can now support clients from start to finish, which means lower tech transfer costs, quicker time to market and our personable service throughout the process," added Dianne.
A dedicated department that includes several experienced formulation scientists has been set-up to support virtual and specialty pharmaceutical companies, hospitals, universities and big pharma firms needing to formulate or reformulate novel, difficult or complex formulations including those that are potent.
SCM Pharma already commands a distinctive position in the global contract drug manufacturing market with its ability to sterile fill finish C-14 radiolabeled and potent products such as cytotoxics.
The contract filling specialist offers sterile services to pharma companies across the world and has specific expertise in the vial, syringe and ampoule filling of liquids, gels and powders. The CDMO has now worked on various product indications across a number of therapeutic areas including cancer and diabetes.
Mitovie Pharma is a privately held pharmaceutical company that develops and commercialises innovative medicines to meet clinical needs. Headquartered in the UK, its portfolio of available medicines span several therapy areas as a result of the company’s strategy of problem solving where there are real medical challenges.