Symbiosis Pharmaceutical Services, a specialist sterile manufacturing CDMO, has reported FDA approval for its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, U.K.
Symbiosis recently hosted a successful inspection by the U.S. 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’s Medicines and Healthcare products Regulatory Agency (MHRA), since 2012.
“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,” Colin MacKay, Symbiosis CEO, said. “This FDA inspection milestone is directly supportive of our recently reported success in being awarded a £1.9 million ($2.4 million) grant from the U.K. governments’ funding body, Innovate U.K.”
CDMO Symbiosis has been sterile manufacturing advanced therapeutic biological products since 2014, and fill finishes viral vectors into vials using validated, bespoke, aseptic processes before subsequent quality control testing, EU Qualified Person certification, and the managed shipment of the product back to the sponsor for onward process for use in clinical trials or commercial supply.
The sterile filling company also has a base located in Cambridge, MA.
(Source: Symbiosis Pharmaceutical Services)