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Re: fluteman post# 768787

Wednesday, 05/21/2025 4:19:50 PM

Wednesday, May 21, 2025 4:19:50 PM

Post# of 827980
From Henry on X:

#AdventBioservices was licensed for "Procurement". The HTA establishment record was last updated on May 19, 2025. There is also a different designated individual.

https://www.hta.gov.uk/professional/establishments/advent-bioservices-ltd

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Here is what Grok says about this (yes I know it's AI):

Streamlining Manufacturing for Commercial Scale:
Operational Efficiency: Prior to the procurement licence, Advent was licensed for storage, distribution, and import of tissues but had to rely on third parties (e.g., hospitals or tissue banks) to source materials. Now, Advent can directly manage the procurement process, reducing dependency on external partners, minimizing delays, and ensuring quality control from the point of tissue collection to vaccine production.

MAA Relevance: The MHRA evaluates the scalability and reliability of manufacturing processes during MAA review. Advent’s expanded role in procurement likely enhances NWBO’s ability to demonstrate a robust, end-to-end manufacturing process, which is crucial for commercial approval. This aligns with NWBO’s earlier efforts, such as the 2022 application for a Manufacturer’s Authorisation for Investigational Medicinal Products (MIA) at the Sawston facility, as noted in the web results.



Perhaps this was one of the missing pieces for why the MAA is still in review.
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