NorthWest Biotherapeutics Inc (NWBO)

[QL300]

This manufacturing process needs to validated as part of the MAA. Multiple regulations require this. The PR says "large scale up of production" not that this is required for approval. Before you say I'm wrong, read below. If I am wrong, cite evidence that contradicts what is found on the MHRA's website. 
The MHRA conducts product-related inspections when assessing an application for a UK https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk. This inspection checks if the manufacturer complies with . We tell you about this inspection in advance.During an inspection the inspection team will:Site visits may include any facility or process involved in producing, purchasing and distributing medicines, including:Here is the link:https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice