RE: CC Podcast29 Nov 2024 11:27
Thank you for this transcript B2H. Always useful to have this form as a reference source.
CC gave a pretty good overview and there is much there to talk about I'll just pick out this: "So the way that we make it for the preclinical studies is very different than the way that we have to make it according to good manufacturing practices for the clinic. That can take some time to get it right, and so those studies have just kicked off for AVA6103."
There is actually a lot behind all this. As CC said, the compound tested in animal models just needs to be 'pure enough', is made using 'test tube' chenistry and is probably made in batches as needed. The purity needs to be at a certain level and there may or may not be stability tests carries out - probably not if it is being made in batches and used fairly swiftly.
However when it comes to testing on humans in the clinic the compound has to be made to a recognised purity, which for marketted drugs is to British Pharmacopoeia (BP) quality or the American equivalent (USP). Because it will be made in bulk, and using a chemical process suitable for bulk manufacture rather than lab quantities (possible a whole lot of chemical engineering work - and patent possibilities - there to get that right), the manufacturing has to be done at a GMP-approved facility (Avacta use a company in Switzerland for AVA6000, so we were told).
Storage conditions of the raw drug compound, its formulated form (powder or solution) and any final administrable formulation (e.g. made up solution of i.v. infusion) have to be defined, which also involves stability testing done on all these forms. You may remember the very strict storage and use by requirements of Pfizer's mRNA covid-19 vaccine.
As you can imagine, all this involves a lot of work, a lot of dealing with contractors and regulatory authorities, and a lot of bureaucracy. You can see the results for marketted products in the 'How to store' section of any patient information leaflet (PIL). And that is only a tiny part of the PIL. Both rampers and FUDsters like to disregard and complain respectively about how long it takes to jump through all the hoops, cross the eyes and dot the teas with all the third parties involved in getting a drug to market. Beware of both.