Ann: CEO Presentation to 2023 Annual General Meeting, page-103

Re: Post #: 71179687

Hi @Grainger,

your recollection matches mine. The variability was reported as having been observed solely in the assay matrix itself, rather than the cells, & so not the much-banged-on-about 'inherent variability of the cells' i.e. the heterogeneity 'concern' or cell bank conditions or inevitable cell manipulation during the assay etc etc. MSB's analysis confirmed to their satisfaction just one of the sourced reagents as the culprit (not sure if it was the reference standard, but seems unlikely).

So, all good. I don't seem to recall any mention of bridging/ qualification studies for any new lots of the critical reagents, at least none ongoing at this time. And AFAIK no new 'processes' to be implemented, no new drug product required to be produced, no new manufacturing site visits required (even remotely). Just the additional potency data from the iterative validation testing, which I understand to be under way.

..and I made it to the plane, despite your best efforts to prolong lunch. What a day.

PS: I did remember to enquire of CEO Itescu whether the company anticipated any risk-based assessment issues, should it agree with Lonza to transfer full-scale manufacture of either platform from Lonza Tuas to Lonza Houston (say) later on. It was of interest to me that the recent FDA Draft Guidance (under docket management for comment until 14 November) didn't seem - on my lay reading - to require any special comparability studies for well-controlled manufacturing site to site transfers. If I understood correctly, CEO Itescu may be thinking similarly. All relevant to scaleup, cost control, and FDA signoff.

Not advice anyone. Do go to next years AGM. They're a bit of a dry biscuit IMO but then you get to have lunch!

Cheers,GLTAH