Symbiosis Secures FDA Viral Vector Process Approval

Symbiosis Pharmaceutical Services, a sterile-manufacturing contract development manufacturing organization (CDMO), announced on Sept. 24, 2018 that FDA approved its viral vector manufacturing fill/finish process at its biologics facility located in Scotland, UK.

The approval was granted following an inspection by FDA for the aseptic manufacture of viral vector products for commercial supply into the United States market at the Scotland facility, which has been licensed by the Medicines and Healthcare Products Regulatory Agency since 2012, the company reports.

“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,” said Colin MacKay, CEO at Symbiosis Pharmaceutical Services, in a company press release.

“This FDA inspection milestone is directly supportive of our recently reported success in being awarded a £1.9 million (US$2.5 million) grant from the UK governments’ funding body, Innovate UK, which was directed at strengthening the position of Symbiosis as a center 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,” commented MacKay in the release.

Additionally, the company offers sterile fill-finish services for conventional, small-molecule drugs in both liquid and lyophilized formulations for use in clinical trials as well as commercial product registration. 

Symbiosis will be exhibiting at Stand 9J40 at CPhI Worldwide, taking place Oct. 9–11, 2018 in Madrid, Spain.

Source: Symbiosis