The move follows a two-year project with UK-based Mitovie Pharma involving specialty drug formulation support for one of its four lead candidates. The, as yet, unannounced drug is being designed in a single use formula for the treatment of accidental overdose.
SCM said it would initially focus on providing developmental services for liquid formulations, such as emulsions and suspensions for parenteral, oral and topical administration.
It will also offer stability and analytical testing support services, along with the capacity to provide good manufacturing practice (GMP) formulation if required.
Dianne Sharp, managing director of SCM. told Outsourcing-pharma.com that: “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.
“The main advantage of this service offering is that through our extensive experience in clinical manufacturing, we are capable of designing formulations with downstream processing in mind.
“Formulations will therefore be developed which are capable of realistic and scalable processing. We will design with the end in mind,” she said.
Analytical laboratories
SCM's preclinical capability will be housed in state-of-the-art formulation and analytical laboratories at the University of Sunderland's new £8.5m ($13m) science complex, situated near to the CDMO's existing MHRA-licensed facility.
A specialist department staffed by SCM's formulation scientists has also been created to support clients needing to formulate or reformulate novel, difficult or complex formulations, including those that are potent.
According to Sharp, introducing the new service offerings represents a natural progression for the company.
“Switching contractors costs clients time and therefore money, loses the advantages of process and product familiarity, and adds risks for clients in the knowledge transfer process,” she said.
“As the industry increasingly shifts to an outsourcing model, clients are looking for contractors with whom they can develop long-term partnerships.”
The company intends to showcase its latest in-house service offerings at ICSE at the CPhI trade show in Frankfurt, Germany, and at AAPS in Washington DC in October.
Patheon investing
Northumberland-based SCM is not the only CDMO to seize the opportunity to expand its core operations into lucrative formulation development services.
Earlier this month Patheon announced it will be “investing in the pharmaceutical development services (PDS) and expanding its presence in early drug development services.”