Adeno-associated virus (AAV) is commonly used as a gene delivery vector for advanced therapy development. The Cell and Gene Therapy (CGT) Catapult has incorporated process analytical technology (PAT) and digital capability into its GMP AAV platform production process with the aim of improving process control via digital twin modelling.
Exemplar batches of AAV serotype 2 (AAV2), containing the gene encoding green fluorescent protein (GFP), were scaled from 2 litre scale to 50 litres and tech transferred in GMP cleanrooms. Concurrently, Endress+Hauser Raman spectroscopy was integrated to an electronic batch manufacturing record (eBMR) system (autoloMATE) allowing use of introduction of novel PAT in a GMP-licensed facility.
Here we report GMP batch manufacturing data at 50 litre scale including QC analysis, demonstrating readiness of the digital CGT platform process for collaborative partners.
