Concept Life Sciences has today announced that it has received certification of compliance with Good Manufacturing Practice (GMP) for the production of active substances at its site in Sandwich, UK. This is the successful outcome of an in-depth Medicines and Healthcare products Regulatory Agency (MHRA) inspection and applies to active pharmaceutical ingredients (APIs) for both human and veterinary use. The certificate demonstrates compliance to safe practices and enables Concept Life Sciences (CLS) to extend its offering to customers, supporting pharmaceutical developers all the way from discovery and early development of candidate molecules to manufacturing drug substances for clinical trials.
The MHRA’s GMP accreditation is the culmination of a 2.5-year investment which has not only created a state-of-the-art facility but also brought together a dedicated team of experts specializing in API development and manufacture. This significantly strengthens CLS’s position as a trusted partner to pharmaceutical, biotech and animal health companies, relieving these clients of the burden of undertaking their own GMP auditing and enabling them to speed their products through to the clinic.
Mark Carnegie-Brown, Vice-President of the Malvern Panalytical Pharmaceuticals and Food sector, commented, “We have always been driven by a strong desire to be the best partner we can be to our clients. This means working to the very highest standards, and the MHRA’s accreditation of our compliance with GMP is a clear reflection of how our people, infrastructure, analytics, skills and processes combine to achieve excellence for our customers.”
Liz Savage, Head of Quality at CLS, also highlighted the importance of the MHRA’s certification to CLS’s clients. “We work in partnership with our clients to deliver tailored, high quality and comprehensive drug discovery and development programs,” said Liz, “so having a GMP-certified facility further simplifies collaboration by providing upfront assurance that our facilities are compliant, without the need for our clients to undertake additional time-consuming audits”.
David Fengas, Director of CMC Services at CLS, who led the investment program, expressed his delight at achieving GMP accreditation: “The past couple of years have been an exciting time for CLS. Our full integration with Malvern Panalytical has allowed us to move beyond the limitations of other CDMOs – we now freely access the technological knowhow to unlock a variety of analytical challenges and bottlenecks. This most recent achievement extends the journey we take with our clients, empowering all companies – no matter their size – to experience a faster, smoother route to clinic, in complete confidence that their project is in the safest hands with the CLS team."