2018 - 12 - 13
Menarini Biotech has established a UK Branch of its process development laboratories at the newly constructed Thames Valley Science Park in Reading, UK. Occupying 400m2 of lab and office space the UK Branch will support the late phase process development and outsourcing of therapeutic antibodies to 3rd parties for contract manufacture to support Phase 3 clinical trials and BLA/MAA submissions.
During 2019 the UK branch will grow from its current size of 4 to a team of approximately 8 scientists and engineers and is closely supported by a group of specialist outsourcing, regulatory and process development/technology transfer (TT) consultants. Its technical activities will be focused on establishing scale-down model processes, determining operational limits, facilitating technology transfer of upstream, downstream and in-process analytical methods and providing the technical support needed during TT and subsequent manufacturing.