Thanks Evaluate. Maybe it was elsewhere that they made the reference to how little tumor material is now required to produce a viable batch. And maybe it was elsewhere that they made a specific reference to patient numbers (in the tens of thousands, iirc) that they can potentially manufacture for at existing plants.
From the list of 'advantages' that NWBO cite and you quote:-
DCVax®-L: Operationally Practical for Commercialization
• Only 1 manufacturing run per patient
• Frozen product (“off the shelf” doses); frozen shelf life validated
• Amenable to automation
• Simple administration to patient: intra-dermal injection
• Compatible with Standard of Care and diverse experimental treatments
• Excellent safety profile – no inpatient or ICU stays and no added drugs to manage side effects
Well what does 'Operationally Practical for Commercialization' actually mean? Not a lot. And really they should have used 'practicable' instead of 'practical', I would suggest!
It's just a sort of nebulous statement really.
At the end of the day, the manufacturing process needs to efficient, with 99% or better meeting of pre-defined specifications for purity and quality, and backed by a failsafe needle to needle tracking and auditing system.
It needs to optimally employ closed automation, and it needs to be readily scaleable.
On frozen product, I'm intrigued by the 'shelf life validated' comment. Well, I've long suspected that the partial hold and shelf life may be somehow connected. Is this a new validation received at the end of the 18 month hold, I wonder?
'Amenable to automation'. Well that also falls into the nebulous, doesn't really mean anything category. Everything can be made 'amenable to automation' if you throw enough money at it, and design custom machines if necessary.
Most of these therapies start out in small research labs where manufacturing processes are largely manual, labor-intensive, and not easily scaleable. Cognate's manufacture for the trial was a sort of halfway house, with an approved process that allowed for some scale-up and some automation. But large scale commercial manufacture is a different order again.
Their other points are fair enough.
No expensive special facilities are required at the treating hospital or clinic. In marked contrast to Car-T, where special ICU type facilities, and specially trained staff are required with intensive patient monitoring for the first few hours and days to watch for life-threatening cytokine storm.
And the ICI's really should have similar intensive monitoring post dose administration due to real risk of serious toxicity after as little as one dose.
I'm sure they are currently preoccupied with all these CMC and related issues, but they don't do a particularly good job of explaining where they are at on this front.
(Well OK, they do a bad job...)
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