Cell Therapy News/Articles, page-17688

Hi @irenekwshiu / @vorzaw

although I'm heartened (yep, pun intended) by this evidence for a new MSB research lab commitment to TX, I'm more immediately interested in the QA activities, already carried out, as they may relate to the FDA.

It seems that Mesoblast personnel were involved in collaboration with what they described as 'global manufacturing and QA teams' to 'establish, streamline, and implement new and existing SOPs' in order 'to support product release testing in a GMP facility'.

So, why 'global' teams? And what 'GMP facility'?

We might think of the FDA's move to expand its reliance on potency assurance strategies & quality by design (QbD), which is part of QA. And also the close working relationship between the global CGT Operations Teams at Lonza Houston (Melanie Mansbach) and Lonza Tuas (Hui Zheng), and Lonza's own videos on the degree of close collaboration & adherence to shared, replicable protocols (a couple of which I've linked to on HC:MSB). We might even connect the dots and see the kind of advantages that might accrue to Mesoblast with early tech transfer (esp. without need for additional process validation) from Lonza Biologics Tuas to Lonza Houston for shortened cold-chain handling, pandemic-proof, scaleable production of both Mesoblast platforms within the USA itself. And the suasive power that might have with the FDA, formulary managers and payers (cf Gamida Cell's Israel-based production facilities).

Just for reference, this is the FDA's newly publicised approach to assay transfers between sites, as confirmed in Potency Assurance for Cellular and Gene Therapy Products: Draft Guidance for Industry (December, 2023) - link here:





Indeed, Lonza itself was interested in this very point & wanted to see better clarification from the FDA on the kind of studies required when moving manufacturing processes between sites. They included it in their comments on the Dec. 2023 Draft Gudiance, viz (at 16,559 below) :


And as I've mentioned on this forum previously, CEO Itescu flagged Lonza Houston as a possibility for this process tech transfer in chat after the AGM. Just a passing comment. But in hindsight it was revealing of the depth of Mesoblast's forward planning, IMO.

All good, and heading in the right direction, IMO.

Cheers