SCM commercial-scale plant gets MHRA nod
Contract developer and manufacturer SCM Pharma sees big potential in sterile drugs and has new plans to help it tap that market. The U.K.-based CDMO has gotten approval from drug regulators in the U.K. to start operations at a new facility in Newburn.
"Sterile drugs are in worldwide demand and we offer a very specialist product," Dianne Sharp, managing director at SCM Pharma, tells BQ magazine. "We're pushing forward in the US, which is a significant growth market for us, but we've also been visiting Japan."
The company said late last week that the Medicines and Healthcare products Regulatory Agency (MHRA) had signed off on the 26,000-square-foot facility. SCM invested £6 million ($9.24 million) in the facility, which will complement a nearby facility that targets clinical manufacturing. BQ says that the company has upped its employment at the facility 40% to 110.
Based in North-East England, the new plant has aseptic processing and terminal sterilization capabilities and is equipped for ampoule filling, vial filling and syringe filling. It is also approved to handle highly potent, flammable and toxic products along with controlled drugs. "The official MHRA approval of our new facility is a huge landmark in the history of our company," Sharp said in a release.
The company said the site also includes a range of packaging and labeling areas and temperature-controlled warehousing as well as other capabilities. A dedicated, enclosed cleanroom suite has also been built that houses an automated syringe-filling and packaging line with full track-and-trace capability.
Contract manufacturing and research organizations large and small have been beefing up their capabilities around the globe. Contract manufacturer Catalent Pharma Solutions this month said it would spend $35 million to add 80,000 square feet to the 100,000-square-foot facility in Winchester, KY. In April, CoreRx said it will invest $2 million to expand its manufacturing operations in Clearwater, FL. Cytovance Biologics, a contract manufacturer of mammalian and microbial biologics, said it is expanding the microbial manufacturing capabilities at its Oklahoma City operation.