The £1.9m ($2.5m) Innovate UK grant was awarded to contract development and manufacturing organisation (CDMO) Cobra and fill/finish services firm Symbiosis Pharmaceutical Services as part of a £4.8m collaboration aiming to support the development of gene therapies in the UK.
Colin MacKay, CEO of Symbiosis, told Biopharma-Reporter the collaboration will bring together “distinct but complementary GMP manufacturing strengths, in drug substance and drug product manufacture,” to create sterile GMP capability to manufacture viral vectors on a commercial scale.
“That commercial manufacturing capability will be co-located in Stirling, UK, alongside the [existing] clinical manufacturing capability, and will stem from upgrades and modifications to the existing Symbiosis facilities,” he said.
“This will be implemented in balance with the ongoing development of increased viral vector drug substance manufacturing scale by our successful grant partner and collaborator Cobra Biologics at their site in Keele, UK.”
MacKay added this will result in a scaled-up viral vector drug development supply chain to be used actively by the two firms’ shared client base.
“Given that the commercial manufacture of Advanced Therapeutic Medicinal Products (ATMPs) is an emerging need and a fledgling market, the final manufacturing capacity will be determined not by us, but by our fast-developing market.”
Viral vector manufacturing has had to develop quickly in response to patient demand for products that are highly effective in the clinic, along with regulatory fast-track approaches to reviewing this type of personalised therapy, MacKay said.
“With increased technological credibility and a growing track record, alongside what appears to be a very welcome regulatory approach which is both constructive and proactive, the hurdles in viral vector manufacturing are more likely to be related to the challenges of bespoke manufacturing processes and the subsequent manufacturing yields.”
He continued: “The challenge of smoothing the drug development process and building efficiency at the interface(s) between the drug development stages, or the respective drug development partners who collectively constitute a time-focussed supply chain, means there is much work to be done to accelerate successful viral vector drug commercialisation timelines.”