SCM Pharma this year stepped into commercial-scale manufacturing with a new plant that got U.K. approval in June. The £6 million ($9.24 million), 26,000-square-foot facility is designed to manufacture sterile injectable drugs. But it is not easy to bust into that market, so the U.K.-based CDMO is trying something a little different.
The company says that it will offer its new cleanroom as a "blank canvas" to potential clients who want to design the process they think will get them what they want. The "bold" move, as the company calls it, is to make its capabilities available to companies that "have a more complex process and sterile product manufacturing need that doesn't fit into the traditional CMO mold," said Dianne Sharp, managing director at SCM Pharma. "Although we are able to provide more standard ampoule, vial and syringe filing under aseptic conditions, we are also able to work with companies in developing novel processes around unusual dosage forms, smaller fill volumes and high containment levels."
The Medicines and Healthcare products Regulatory Agency (MHRA) in June signed off on the plant in Newburn, in northeast England. It is approved to handle highly potent, flammable and toxic products, along with controlled drugs. The site also includes a range of packaging and labeling and temperature-controlled warehousing. SCM says it has a packaging line with full track-and-trace capability.
The contract manufacturing market is growing as more companies look to cut costs by closing plants and using third-party partners for specialized needs. The sterile injectable market also is drawing more players, as well as expansion by well-established operators. The medical technology company Becton Dickinson ($BDX) got FDA approval this year for its first sterile injectable drugs, and has plans to roll out 20 to 30 more over the next several years. Generic drugmaker Mylan ($MYL) is about to close on its $1.6 billion acquisition of India's Agila Specialties, which has modern and extensive injectables manufacturing.
- here's the announcement