ATMP therapy developers can reportedly save several weeks of precious drug development time
Contract manufacturing organisation Symbiosis Pharmaceutical Services has announced the completion of a £1.3m collaborative UKRI-funded project as part of the medicines manufacturing challenge.
Symbiosis, with The Cell and Gene Therapy Catapult (CGT Catapult), has developed and demonstrated a lean manufacturing supply chain in partnership with Freeline Therapeutics for the sterile filling and manufacturing process of drug product.
The collaboration established a process with an advanced testing package, avoiding the historically required long lead-time for testing for adventitious agents. It also includes an improved contamination control process, an inherently challenging aspect of viral vector processing in a multi-product facility designed to process multiple ATMPs and other therapeutics.
The process can potentially save ATMP therapy developers several weeks of precious drug development time in selecting the correct regime for disinfection of the facility post-manufacture, avoiding the need to test efficacy with each individual biopharmaceutical product, the company claims.
The project learnings are hoped to accelerate the manufacturing supply chain for ATMPs within the UK.
John McCormick, COO of Symbiosis said: “The results are very positive. The aim of the project was to reduce the production cycle by up to 25%. Shortening timelines reduces storage costs and can increase manufacturing facility utilisation. For many drug development projects, reducing manufacturing timelines, even by a few days, can facilitate these life changing medicines entering the clinic sooner.
“Initiation of drug product manufacture and processing at Symbiosis for the Freeline viral vector was able to start approximately four weeks from completion of drug substance manufacture and release testing at the CGT Catapult in Stevenage, UK. This compares to typical post-release testing timelines of up to 12 weeks; representing a reduction in the timeline of over 60%.
Matthew Durdy, CEO of CGT Catapult, also commented: “We are pleased with the outcome of our collaboration with Symbiosis. This project, in partnership with UKRI, highlights the importance of collaboration between industry partners to further develop and improve the supply chain for ATMPs. This project is testament to the UK’s leading position in ATMP manufacture and we look forward to future projects with Symbiosis that will benefit from this reduction in manufacturing timelines.”