Skip to content Skip to navigation

Random Thursday: Now with more randomness!

Thursday, September 15, 2016 - 16:55

I had a topic I was thinking of doing today, but insufficient brain to manage it. I have one more chapter to revise of Mother of Souls--and then at least a couple more passes to make sure I haven't screwed up anything else in the process--and it's eaten up everything I have left over from work. Work, now there's something I could talk about. Not a lot, of course, because the details are often sensitive. But just in general terms of "what is Heather doing these days in her day job?"

As you know (Bob), I work for a major international pharmaceutical company. My department does the purification of biologic molecules used to treat a certain hereditary disease. Periodically we improve either the manufacturing process or the molecule itself so that it works better, is safer, is more effective, or some other improvement. For non-biologic chemicals, there are a lot of changes where approval just requires demonstrating equivalence. For the sort of thing we make, pretty much any change worth making gets treated as an entirely new drug. So you start out with a relatively limited developmental manufacturing process for your clinical studies that demonstrate safety and effectiveness. My department isn't involved with that. And then you design your commercial-scale manufacturing process, construct any new equipment or facilities required, validate your equipment and processes, train everyone on how to use them, and then you produce a certain amount of drug to demonstrate that you are making material equivalent to what was used for the clinical studies and that you can manufacture it consistently and reliably, meeting established standards for all your quality specifications. Oh, and we do this using a living organsim as part of our "factory" with all the complexity inherent in that.

That process is what we're just finishing up with at the moment. It's pretty intensive because all the data from this initial full-scale production will be worked over with a fine toothed comb by the regulatory agencies who decide whether they're going to approve your license to manufacture and sell the stuff. It's also intensive because there are a lot of timelines that are ticking forward to the point when you've gathered all the data from this phase and submitted it and gone through the audits and inspections until the day comes when the new drug is approved. Nobody goes into this sort of process unless they're absolutely certain it will be approved, but that doesn't mean stuff can't happen.

We went through this process recently with one new version of the drug. There's a poster in one of our buildings with a picture of the first does being hand-delivered to its user. It's a big deal. The process is long enough that you've usually working on the next improvement before the last one is in patients' hands.

Big Pharma comes in for a lot of criticism, and I'm not going to defend everything that goes on. Not by a long shot. But I get to see the inside of the process that takes an idea from "this might work to help someone" to "here's your next dose of the stuff that keeps you alive."  Some of the stuff we do is f'ing miraculous. And I get to be a part of that.

And that's what I do when I'm not writing books.