Symbiosis Pharmaceutical Services, a fast-growing specialist sterile manufacturing CDMO, has reported FDA approval for its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, UK.
The firm ecently 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, CEO at Symbiosis Pharmaceutical Services, commented: "The approval of this process by the FDA is testament to our technical experience, capabilities, and specialist understanding of viral vector filling in compliance with the highest of regulatory standards.
"We have been honing our niche viral vector handling and manufacturing skills for several years and have dedicated resource and effort to maintaining the strict quality standards and expertise required to make the commercial GMP sterile filling of viral vectors a core capability. 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."