High-throughput purification method for adeno-associated viruses using capture plates.

High-throughput process development for AAV products is challenging; the upstream process generates an AAV containing cell lysate in which many CQAs cannot be assessed due to low titre and sample complexity. The sample volume available from small-scale USP optimisation studies, taking place in multiwell plates or bioreactor systems, prevent samples from being processed through standard DSP operation units which are low throughput and can take >10h for the purification of one sample. Capture plates implement affinity chromatographic techniques to allow for the rapid clean-up of up to 96 AAV containing lysate samples in a single process. The samples produced by capture plates have sufficient titre and purity for most analytical methods, CQA’s such as percentage full capsids to be obtained from milli-scale upstream processes through characterisation techniques such as SEC-MALS, HPLC and mass photometry which have low sample volume requirements.