Symbiosis Secures FDA Approval

09.24.18

For its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, UK

Symbiosis Pharmaceutical Services has announced the FDA approval for its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, UK. 

Symbiosis recently hosted a successful inspection by the United States Government Food and Drug Administration (FDA) for the aseptic manufacture of viral vector products for commercial supply into the U.S market at its GMP manufacturing facility, which has been licensed by the United Kingdom governments’ regulators, the MHRA, since 2012.

Colin MacKay, chief executive officer at Symbiosis Pharmaceutical Services, said,  “This FDA inspection milestone is directly supportive of our recently reported success in being awarded a £1.9m (US$ 2.4 m) grant from the UK governments’ funding body, Innovate UK, which was directed at strengthening the position of Symbiosis as a centre of excellence as part of the viral vector drug development supply chain, and firmly consolidating the commercial viral vector manufacturing capability of the UK as a global leader in this field."

Symbiosis has been sterile manufacturing advanced therapeutic biological products since 2014, and routinely fill finishes viral vectors into vials using validated, bespoke, aseptic processes before subsequent QC testing, QP certification and the managed shipment of the product back to the sponsor for onward process for use in clinical trials or commercial supply.

As well as the growth of its specialist viral vector filling services, Symbiosis also services the demand for sterile fill-finish of conventional small molecule drugs in both liquid and lyophilised formulations for use in clinical trials, and also has direct experience of supporting fast-track commercial product registration.