Lentivirus Project – US Biopharma

eXmoor was approached by a biotech company with a lentiviral platform for a cell- based therapy in clinical phase 1 with lentivirus drug substance stability concerns.

The eXmoor team tech-transferred the existing process in the development lab and screened drug substance formulations, optimised the fill-finish in the GMP suites and generated live and accelerated stability data to support the shelf-life of the intermediate product.

The translation team supported with regulatory filings and comparability study requirements to support the change in formulation. A 18-month lentivirus stability was demonstrated and the optimised formulation is now used in Phase 2 of the therapy.