Formulation, Fill and Finish of Lentiviral Vectors -Part 2: Key Decisions and Risk Management

摘要

Over the past few years, Oxford Biomedica UK has developed and implemented its fill-finish platform at its 84,000-ft2 "Oxbox" manufacturing facility constructed in 2019. The first phase of development (45,000 ft2)houses four segregated suites for producing bulk viral-vector drug substance (VS) where closed systems and bioburden-control processes apply, and two fill-finish suites for viral-vector drug product (VP) in aseptic processing. The first of the fill and finish suites is expected to be approved in the first half of 2022.