Symbiosis launches multi-million pound sterile drug manufacturing capability
Receives MHRA licence to manufacture sterile liquid drugs in Stirling, Scotland
Symbiosis Pharmaceutical Services has been granted a licence by the MHRA, the UK government regulator, to manufacture sterile liquid, lyophilised, conventional, cytotoxic and biological drugs for biotechnology company clients around the world.
The Stirling, Scotland-based firm specialises in the small-scale contract manufacturing of sterile pharmaceuticals for clinical trials (fill/finish). Formed in 2011, Symbiosis has a team of 17 people and has successfully completed clinical trial manufacturing projects with clients in Europe and Asia, including Zealand Pharma and Encap Drug Delivery.
Colin MacKay, founder and chief executive of Symbiosis, says the firm built, qualified and licensed its new manufacturing facility within a matter of months.
‘Our intention is to be both the fastest, and the best, small-scale sterile fill/finish company in the world,’ he says.
The new Symbiosis manufacturing facility includes two manufacturing suites, one of which is capable of handling cytotoxic and highly potent pharmaceuticals, built with integrated Restricted Access Barrier System (RABS) technology.
While Symbiosis specialises in phase I and phase II GMP manufacture of liquid, lyophilised, conventional, cytotoxic and biological drugs, it also provides a range of closely associated services, including analytical testing, clinical labelling and packaging, Qualified Person release and controlled temperature storage and shipment.