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Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.
Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility following increased demand for its services from both the US and Europe, the company announced in an Oct. 12, 2015 press release. The CMO will increase floor space at its site in Stirling, Scotland by 20%, adding a new controlled-temperature storage area and further room for its growing quality and project management teams.
The extension comes just a year after the company was granted a commercial manufacturer’s/importer’s license by the Medicines and Healthcare Regulatory Agency (MHRA) for the GMP-manufacture of aseptically-filled, licensed commercial products to complement its existing investigational medicinal product license. Its core business remains the sterile fill/finish of biologic and small molecule products into vials for clinical trials, but the CMO has branched into providing a solution for increasing numbers of small-scale commercial manufacturing projects.
“The decision to expand our facility comes both as a result of growing client demand for our small-scale sterile manufacturing services and also in line with the latest guidelines from the MHRA. This year’s CPhI in Madrid is the ideal platform to communicate this news to the industry,” said Colin MacKay, CEO at Symbiosis Pharmaceutical Services, in the press release.
“As we scale-up and regularly manufacture both commercial and clinical drug products, it’s essential for us to plan ahead with regards to product segregation and storage to ensure we continue to meet the gold standard regulatory compliance guidelines demanded by the MHRA both now and in the future.”
Symbiosis has thrived in the past year as a consequence of wider industry trends such as the increased number of injectable drugs in development, increased biotech funding, and from more oncology and orphan drugs demanding the specialist manufacturing strengths of Symbiosis. The CMO specializes in injectable medicines, which are either liquid or lyophilized formulations filled into vials. Its specialist capabilities include the ability to handle and fill antibodies, proteins, peptides, nucleic acids, cytotoxic, cytostatic, and highly potent APIs, including antibody-drug conjugates along with conventional small molecules.