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Old 03-21-2020, 03:56 PM
Treppenwitz is offline
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Join Date: Jan 2018
Location: UK
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Quote:
Originally Posted by OldOlds View Post
I'm not in tablets, I'm in injectables (parenterals, in industry jargon)

The good news is that tablet manufacturing is much simpler, with far fewer controls needed. I don't know where CP tablets are made. If there's an FDA-approved facility making them now, that could be ramped up quickly. You'd be amazed at how fast tablet facilities can crank out pills.

In normal times, I'd assume about 12-18 months to convert an existing line to a new product and complete all the validations and inspections. A solid 6+ months of that is the FDA, which could presumably park a team at the plant and cut that Waaaay down in an emergency. With all hands, maybe the changeover could be cut in half. Perhaps some time could be saved by skipping things like stability testing (the calendar is the calendar, so a six month stability takes six months; but for a well established medicine we might decide that isn't needed in an emergency).

So my back of the envelope would be 4-6 months with a Manhattan Project effort.

That assumes the CP itself (known as the Active Pharmaceutical Ingredient, API) is readily available. APIs are typically made at a very different facility than the tablets. If API production needs to be ramped up that could be the real bottleneck. Since I don't know how CP is synthesized I can't say what's involved there. But proper production and safety of the API will be the most critical element of a tablet (I mean, something wrong with the binders isn't likely to kill anyone), so any shortcuts there would have to be taken very carefully.

As for grades and whether (say) using a reference grade, or an industrial grade is safe, well... I wouldn't take my chances. Things produced for human use are done under a very strict set of rules and oversight. Just because someone gives you a CoA for something made under "industrial" rules wouldn't be enough for me. And tiny changes or impurities can be devastating.
My bolding.

This point was rather thrown away by OldOlds - it really deserves to be emphasised.

Here's a tablet machine with a maximum capacity of just over one million tablets per hour. Yes, that's one tablet machine's output. Now, maybe you have to get an order onto a waiting list for this model, but my first hit on google was this little number which you can pick up second hand and which runs at up to three quarters of a million per hour - yours for 120 000 Euro; you'll have to buy the punches and dies separately. The things that slow you down are cleandown between batches and the logistics of feeding the damn machines. And then there's the issue of packaging those millions of tablets and getting them to warehousing.

I'm not an expert in setting up tablet production lines either (retired from the licensing side) but OldOlds' analysis doesn't sound a million miles away to me - if you need to set up a new line rather than take over and repurpose an old one. These tablets are already being produced, right? And are on the market internationally? If that's the case then it becomes, as the OP put it, a ramping up of existing production, so far as that is possible. I would hope that could be done in less than 4 months, but that leads to the question of where manufacturing is currently taking place. For an old drug like this which is primarily used for a tropical disease, who knows where the manufacturing sites are. Depending on location, upgrading an existing line may not be that simple.

The in-between solution would be to use existing contract manufacturing lines, essentially transferring an existing manufacturing process in (including the analytical procedures etc). You may be able to shorten the start-up in that way, so this approach is a hybrid of upgrading existing lines and the process OldOlds described.

There's a knock-on issue of needing to produce medicines for many, many millions of patients worldwide - is there enough spare capacity in the system for that to be handled without causing shortages elsewhere? It'll be a challenge.

So: I'm addressing the OP; but hey, how about we find out if this stuff even works first?

j

Last edited by Treppenwitz; 03-21-2020 at 03:58 PM.