Aseptic Processing Platform

Oxford Biomedica UK Integrated Aseptic Processing Platform For Multiple ATMP Indications Including A Case Study On A Viral Vector Used In CAR-T Cell Cancer Therapy

Presented by Melanie Bull and James Drinkwater at ISPE Aseptic Conference 2nd March 2020:

ATMPs require new and innovative process solutions based on Aseptic processing that follow QRM principles when adapting generic GMP. The new OXBOX facility at Oxford BioMedica includes an integrated formulation and filling platform, primarily based on single use systems, pre-sterilised containers/ closures and automated vial filling, provided by Flexicon Liquid Filling, a member of the Watson-Marlow Fluid Technology Group company and barrier technology with integrated vH202 decontamination provided by Franz Ziel GmbH.

Formulation and vial filling is on a flexible combined platform that is suitable for a ‘scale out’ approach so with increasing demands different ATMP indicators can be processed. Where there are limitations in ATMP process time because of ‘Thaw-Freeze’ process windows efficiency is achieved by process integration and minimised in-process transfers across different zone grades. Aseptic containment plays a role in the OXBOX process design to process different products where cross contamination control is critical. This presentation covers a learning and key decisions made, via a case study, of developing a multi-indication ATMP process platform with focus on one application of processing a lentiviral vector produced as single source by Oxford Biomedica (OXB) for their collaborator Novartis and used in the CAR-T cell therapy Kymriah®.