SCM Pharma’s $10 million 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). 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 U.K.-based contract development and manufacturing organization (CDMO) will use its 26,000 ft2 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 Northeast 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.
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.
The site includes a range of packaging and labeling 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 headquarters 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.
Release Date: June 19, 2013
Source: SCM Pharma