Company goes all out to fully support clients

Gaining GLP/GMP accreditation to provide greater assurance of data integrity for clients looking to take their compounds to IND.

Which sites is Concept planning to be GMP/GLP accredited? Why these sites and why now?

Our current plan is to develop our Dundee site to cover all the assays (Bioanalysis, Dermal, In vitro cellular bioassays and Toxicology) under GLP accreditation. In addition, we are working with the Alderley Park team to establish GLP toxicology studies. At Bradford, we will expand our service offerings to include GLP Analytical work to support the chemical and agrochemical sectors, as well as running the GMP-accredited pharma services for batch release, stability and product development. We will then complement our Bradford GMP services by expanding the Sandwich facility to offer cGMP manufacture of API up to 5 kg; this allows the production of sufficient material to run IND studies.

In the past, we have run many of our in vitro, in vivo and analytical studies to the general principles of GLP without making any claim of accreditation, but to be able to fully support clients in taking their compounds to IND the studies must be completed to GLP. Furthermore, the increasing number of chemical and agrochemical clients we serve were seeking much greater assurance of data integrity, hence for all these reasons the right decision is to have our facilities GLP accredited.

What is Concept doing or has done to ensure its relevant sites gain the accreditation?

We have dedicated teams with their own individual Project Manager who runs the program of work needed to gain accreditation at each of our sites. Each team reports to a Steering Committee that reviews weekly progress made against a plan. The teams are made up of operational and quality staff, as well as local site management. The teams monitor the progress of the quality systems implementation (SOPs, policies, audits), training, recruitment of new experienced staff, and any necessary facility upgrades/changes required to gain accreditation.

We are also engaging with external specialist consultants where necessary to advise on specific areas, such as cGMP to complement the knowledge of our existing staff. In addition, we have held discussions with the MHRA about our plans and are updating them regularly.

How will the accreditation expand services to manufacture API material and further support the development of compounds from the discovery stage to full IND packages?

The addition of cGMP manufacture of the API and the GLP services to cover the studies required for IND packages will provide the client with a more complete service offering. Furthermore, the newly formed Program Management department will coordinate, monitor, report and act as the client advocate, ensuring work is completed on time and on budget to provide a high-quality service offering.

Comparing now with post GXP accreditation, how exactly will clients benefit?

The benefits to clients as a result of these additions will not only include added data integrity, but also a more complete service offering to fully support their needs.