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 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.
“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,” Colin MacKay, CEO at Symbiosis Pharmaceutical Services, said. “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.”
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.