Sterling Expands API Capabilities

Contract development and manufacturing organization (CDMO) Sterling Pharma Solutions is investing £6 million into a new facility at its UK site to strengthen and expand its milling, micronization and solid form capabilities.

The 40-acre site in Dudley, North East England, will meet growing demand for pharmaceutical API particle size control technology, as well as expanding Sterling’s laboratory capabilities to provide a full solid form offering including polymorph screening, salt selection and particle engineering and crystallization scale-up.

Four new milling areas will house a range of new technologies, including mechanical milling, spiral jet milling and small lab scale trial mills. Supporting the CDMO’s expertise in handling potent and hazardous materials, the facility will also provide containment to handle OEB 4 classified molecules and offer ISO 8 cleanroom environments.

"From our UK facility, we are building a global API services business with customers in the U.S., UK, Europe and Asia," said Kevin Cook, chief executive officer, Sterling Pharma Solutions. "This latest investment is an important step in bolstering our offering so we can cater to growing market demand, including the need for high potency capabilities to reflect the global drug pipeline.

"We are proud that we can take products from proof-of-concept to commercial scale manufacturing all on one site, and the new facility will strengthen our current offering by adding additional milling, micronization and solid form capabilities."

Established in 1969, Sterling’s site has a strong heritage in API services and a successful track record of compliance with both the MHRA and FDA. The investment forms part of a 15-month strategic development plan totaling almost £12 million, which will also see the expansion of the CDMO’s GMP kilo laboratories and pilot plant.

Expected to be operational by mid-2018 the milling, micronization and solid form facility will create more than 15 jobs over the next 18 months, bringing Sterling’s total workforce to around 400 employees.

"Our strong growth can be attributed to a number of factors, including the emerging pharma sector in the U.S. and big pharma demand for the complex and hazardous chemistries we provide," said Mr. Cook. "We have focused our strategy on the diversification of our customer and product base and have recently expanded our presence in the Asian markets including Japan. We will continue to invest to ensure we meet the diverse needs of our customers globally."