Symbiosis secures FDA viral vector process approval5 Oct 2018
Strengthens the CDMO's position as a centre of excellence as part of the viral vector drug development supply chain.
Symbiosis Pharmaceutical Services has reported 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 FDA for the aseptic manufacture of viral vector products for commercial supply into the US market at its GMP manufacturing facility, which has been licensed by the UK government's regulators, the MHRA, since 2012.
Colin MacKay, CEO at Symbiosis Pharmaceutical Services, commented: “The approval of this process at Symbiosis 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 at Symbiosis.
“This FDA inspection milestone is directly supportive of our recently reported success in being awarded a £1.9 million (US$ 2.4 million) grant from the UK government's 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.
“The FDA approval of Symbiosis, alongside its Innovate UK grant success, represents a significant positive indicator which supports the development of world-leading capabilities for clinical and commercial production of gene and immunotherapy viral vector drug substance and drug product manufacturing in the UK.”
MacKay continued: “Our ability to offer rapid access to sterile manufacturing slots has been a key competitive differentiator compared with the larger CDMOs in the outsourcing marketplace and has succeeded in leading to long-term relationships being built with pre-clinical, Phase I-III, and now commercial-stage biotech and pharma companies worldwide.”
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