Yes. SOW-8 was carried out at Sawston, and every element of it required a functioning Grade C cleanroom at that location. The APS, PPQ, equipment validation, sterility testing, growth-promotion testing, flow-cytometry assay validation, and fill-finish validation disclosed in NWBO’s own 10-Q cannot legally be performed anywhere except inside the actual GMP rooms where manufacturing will occur. Those activities require licensed Grade C/B/A environments under Annex 1 and ISO 14644, which exist only at Sawston. This is reinforced by Advent’s MHRA manufacturing authorizations, the GMP Group’s documented qualification of Advent’s aseptic suites, and the Cell & Gene Therapy Catapult database listing Advent with operational Grade C cleanrooms before the new suite announcement. The new Grade C manufacturing suite in the recent PR is a scale-out addition, not the first instance of Grade C capability.
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