Scottish CMO to increase facility floor area by 20%
Scottish injectables manufacturer Symbiosis Pharmaceutical Services has revealed plans to expand its sterile filling facility following increased demand for its services from both the US and Europe. The contract manufacturing organisation (CMO) will increase floor space at its Scotland-based site 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 licence 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 licence.
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.
Colin MacKay, CEO at Symbiosis Pharmaceutical Services, said: '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.
'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.
'We are proud of our growing reputation in the global market for providing clients with rapid access to sterile manufacturing slots and quick release of drug products to ensure that our clients’ tight timelines are met. With this in mind, it’s important we accurately forecast to ensure we have the capacity to meet customers’ needs and to underpin the strong relationships we have built with our clients.'
Symbiosis has thrived in the last 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 specialises in injectable medicines, which are either liquid or lyophilised 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 ADCs along with conventional small molecules.