MHRA Approval for CDMO’s Commercial Facility
News Jun 20, 2013
SCM Pharma’s new £6m ($10m) pharmaceutical contract manufacturing facility has been given the go ahead for commercial production following a successful inspection from the Medicines and Healthcare products Regulatory Agency (MHRA).
The UK-based contract development and manufacturing organization (CDMO) will use its new 26k sq. ft. site for the supply of licensed commercial products and to complement its nearby clinical manufacturing facility for projects requiring scaled-up clinical trial supply quantities.
Based in North-East England, the contract drug manufacturing site is able to handle highly potent, flammable and toxic products along with controlled drugs.
It houses technology for aseptic processing and terminal sterilization capabilities and is equipped for ampoule filling, vial filling and syringe filling.
Dianne Sharp, managing director at SCM Pharma, said: “The official MHRA approval of our new facility is a huge landmark in the history of our company and heralds in a new era for our team.
“I’d like to thank all those involved in the planning, design and construction of SCM Newburn as the end result is what I believe to be one of the finest contract manufacturing facility of its type in Europe.
Sharp continued, “We are planning an event to officially open the doors this summer before Newburn becomes a hub for the production and supply of licensed drug products to help patients across the world.”
Independently-owned, SCM Pharma specializes in the sterile manufacturing of drug products that require high containment. Most of the CDMO’s contract filling projects assist companies requiring products for clinical trials or licensed drugs needed in niche commercial markets such as orphan drugs.
With commercial scale cleanrooms, which include a potent suite, dedicated commercial suite and Grade C/D rooms, the new site massively increases SCM Pharma’s current and future capability and capacity.
The site includes a range of packaging and labelling areas, temperature controlled warehousing, raw materials and engineering preparation, visual inspection and leak testing.
A dedicated, enclosed cleanroom suite has also been built that houses an automated syringe filling and packaging line with full track and trace capability.
The company’s HQ is dedicated to development and clinical trial supply projects that involve investigational medicinal products and also supports ADME studies requiring the supply of C-14 radiolabeled compounds.