SCM Pharma’s $10 million 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 U.K.-based contract development and manufacturing organization (CDMO) will use its new 26,000 ft2 site for the supply of licensed commercial products and to complement its nearby clinical manufacturing facility for projects requiring clinical scale-up. The site is able to handle highly potent, flammable, and toxic products along with controlled drugs. It houses technology for aseptic filling and terminal sterilization capabilities and is equipped for ampoule filling, vial filling, and syringe filling.
With commercial scale cleanrooms, which include a potent suite, a 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 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.
Release Date: June 21, 2013
Source: SCM Pharma
