Construction of an ATMP manufacturing facility and scale up of production: Advent Bioservices

Abstract

Background & Aim In recent years, the UK cell and gene therapy industry has expanded rapidly. Cleanroom space capacity has increased during the last five years to a total of 7,819m2. In 2019, cleanroom facilities in the UK ran at 72% of operational capacity on average with 80% generally considered full. This demand has been driven by the success of the UK in capturing a disproportionately high level of investment and clinical trial activity. Between 2014 and 2019, the UK initiated 112 new ATMP clinical trials which was the highest total figure for any European country. This increase in the number of candidate treatments is projected to increase the production of ATMPs from hundreds to tens of thousands per year by 2028, resulting in strong demand for GMP manufacturing services and expertise in commercialisation and scale-up of manufacture. Advent Bioservices began activity as a cell therapy contract development & manufacturing organization in 2016 and is in the process of building a state-of-the-art multiproduct GMP production facility outside Sawston in Cambridgeshire, which will allow the scale up of current commercial production and the provision of contract manufacturing services to meet the growing demand for such services in the UK. Methods, Results & Conclusion The Sawston facility is located just 7 miles outside Cambridge city centre with excellent transport links to Central London, London Stansted airport and is 4 miles from the M11 motorway. The facility consists of 1700m2 of GMP lab space, 325m2 for process development and an additional 1450 m2 for future expansion. Initial construction work has focused on the building of 2 separate GMP suites with grade B/C classified areas, in house QC testing and office space as well as a multipurpose cryogenic storage unit. The entire facility will operate under a comprehensive IT infrastructure including eQMS and an eBMR, with a LIMS with secure storage for client documents and paperless systems. Clients operating within these suites will benefit from already validated cleanrooms, in-house environmental monitoring system as well as training, ancillary services and technical support inclusive of process development and validation. Our cryogenic facilities are available to external clients as off-site storage and offer disaster recovery services as per UK regulatory (HTA) requirements. Advent Bioservices is currently in the process of applying for licencing and accreditation from UK authorities including the HTA, MHRA and HFEA for the Sawston site.