Geeking out on polymer manufacturing

Linda Brent, PhD

Executive Director, Parsemus Foundation

Read this only if you want to know what goes on behind the scenes while making a new contraceptive medical device! These are some of the questions and issues that keep us up at night….

Vasalgel is made out of a powder (SMA) and a liquid (DMSO). Making the powder part is actually pretty complicated and is the subject of patents. But once the powder’s made, mixing it into the liquid ought to be easy, right? Unfortunately, not so much.

If you’ve ever made hot chocolate or a protein shake, you know that mixing a powder and a liquid isn’t always easy! Do you take the liquid and try to very slowly stir in the powder? That’s what we’ve been doing, and it works reasonably well on a small scale. But keep in mind, this gel gets super-thick, like glue (or honey- and we’re talking honey that’s been sitting on your counter at room temperature, not honey you zapped in the microwave to soften it up!).

The next problem: Clumps. You know this issue if you’ve ever tried to make a protein shake. So guess who knows the answer to clumps? Turns out it’s athletes, and people who know how to cook! Do a little investigating, and you’ll discover that when making a sauce, experienced chefs never add flour or corn starch, for example, to the milk or liquid. They put the flour in the pan first, then slowly add liquid to make a paste. (Yes, you can pat yourself on the back if you already knew that… You get serious “grownup” points!)

Or what about high-tech approaches? It’s 2016; shouldn’t there be high-tech ways to mix up a powder and a liquid in a more sophisticated way than making a paste or putting them in the industrial equivalent of a Hobart mixer?

You’d think that pharmaceutical manufacturing companies would be prepared to address these issues. But it turns out most pharmaceutical manufacturers deal with thin liquids (think of a vaccine, for example), and just stirring those is good enough. They don’t have to really mix something with the consistency of glue.

Luckily, there’s an alternative to drug manufacturing companies: medical device manufacturing companies. These guys (and gals) already work with super-thick substances such as silicone. Not only do they know how to mix viscous material, they know how to pump it into thousands of vials — all while keeping it protected, and all to regulatory requirements. After a long search, we’re lucky to have found one of these companies that’s really responsive, and we’re excited to work with them.

So it turns out that what seems like it might be the easiest part of the process is actually one of the trickiest! That’s what goes into making the vials of gel that get whisked off to stability studies and toxicology studies, all in preparation for the clinical trial.

We’re sorry, you are not eligible for the nationwide COVID-OUT or ACTIV-6 studies, but you may be eligible for other federal trials:

And if you don’t find a match there, this slightly more complex clinical trials finder includes studies sponsored by companies as well:

Trials Today