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Re: Lykiri post# 410222

Tuesday, 10/19/2021 8:53:54 AM

Tuesday, October 19, 2021 8:53:54 AM

Post# of 694211
Don't know if you have cited this reference previously, Lykiri: but we did get a brief mention in the most recent annual Catapult review of UK ATMP/GMP manufacturing, which was issued in Nov '20.

Under the 'Future Capacity and Expansion' section, it was stated:-

"Advent Bioservices is currently managing the development of a state-of-the-art facility for multiproduct GMP production outside Sawston in Cambridgeshire, which will allow scale up of commercial production and initiate the provision of contract manufacturing services. The facility consists of GMP lab space and process development and additional areas for future expansion.
Initial construction work has focused on the building of 2 separate GMP suites with grade B/C classified areas, in house QC testing and office space as well as a multipurpose cryogenic storage unit. The facility will operate the facility under a comprehensive IT infrastructure including eQMS and an eBMR, with a LIMS with secure storage for client documents and paperless systems."


Page 18.

https://ct.catapult.org.uk/sites/default/files/publication/ManufacturingReport2020_PUBLISHED.pdf

I see a lot of references (not by yourself) on IHub to Sawston getting certified (for manufacturing) shortly..
More correctly, the term is licensed.

And I hope and expect that indeed it will be licensed for manufacturing shortly!

Regards.
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