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The long-acting, nonhormonal contraceptive - for men.
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November 19, 2014
Behind the scenes: Manufacturing 101
What does it take to get a new contraceptive to market? It takes a team of experts to develop a product to the stage of conducting clinical trials. In our last update, we promised a report from our science coordinator - an M.D. who founded a medical pathology company and now consults with biotech firms like us. Dave is wrangling manufacturing, stability testing, and ISO safety testing, all of which have to be done in the next few months before the first clinical trial can start next year. It's heavy-duty stuff, but he does a great job of keeping it all straight. Here's a look behind the scenes:

We start by defining the product. Before I can buy a single ingredient or contract out production, we categorize every important detail into technical documents. These documents are our protocols and specifications, developed from the last few years of research and development. They define the standards for each ingredient, instrument, test, or condition, even down to the temperature and humidity of the air. They guide us to reproducibly make Vasalgel that meets the high standards of clinical use. From this foundation, we conduct three sequential processes: Polymer synthesis, device assembly, and device qualification.

Polymer synthesis
During polymer synthesis, small individual molecules called monomers undergo a chemical reaction that links them together to form long chains called polymers. I think of polymers being similar to a paperclip chain, but much more complex.

The synthesis of the Vasalgel polymer occurs under very tightly monitored conditions and requires several steps over seven days using highly sophisticated equipment. That is a lot of work, but in the world of polymer chemistry, it is less complex than many processes.

Assuring quality requires that the synthesis process is done the same way every time. It requires the highest grade of raw materials and pharmaceutical grade reagents. But this is not all: each batch of material is analyzed and compared to our specifications. If it falls outside the specifications in any parameter, it is rejected.
Photo courtesy
Device assembly
Device assembly is the technical term used for dissolving the polymer, sterilizing it, and loading it into syringes. This occurs in a cGMP (highly regulated) facility under tight control.

Device assembly begins with milling, which is the grinding of polymer pellets into fine powder. Then, the powder is dissolved into a biologically safe solvent. Even though testing so far has found no biological contaminants, we filter it through 0.2 micron pores to assure sterility. These pores are about one ten millionth of a yard in size, which is much smaller than any bacteria or fungus. The resulting material is Vasalgel.

Vasalgel is then aseptically (sterilely) loaded into syringes, capped and sealed in sterile packaging, ready for use.

Device qualification
Great! Now we have kits of Vasalgel ready for clinical trials, but they first must be qualified. Qualification is all about SAFETY! We need to test the kits to demonstrate that they are fit for use.

Three types of tests are conducted. Biocompatibility tests (also known as ISO 10993 studies) show that the Vasalgel is safe and does not damage DNA. Stability studies determine how long the materials last and what the safe shelf life will be. Every batch is also tested to ensure that there are no infectious organisms and materials that can cause fevers (also known as pyrogens).

In addition to these tests, the kits must be manufactured under regulatory guidelines and receive governmental approval for initial clinical trial use and later for standard medical use.

We're working hard to get all that done in time for the first clinical trial to start this coming year.

Help get Vasalgel to market!

Thank you Packard Foundation!
As reported in our last update, we got the grant from Packard Foundation! They're the first foundation to stand up and say men deserve reproductive control too. We're tickled pink to see that a number of Vasalgel supporters feel passionately enough about thanking them to have gotten out actual stamps and thank-you cards, despite all the things competing for everyone's attention this time of year. Thank you, Vasalgel supporters!

New advocacy organization: Show your support
Here's something you can do quickly: Sign up for the new male contraceptive advocacy organization. And this one was actually started by men! Aaron Hamlin (a longtime Vasalgel supporter and a seasoned activist with a master's in public health) and the scientists he is working with have given it six months to see whether it gets off the ground. They're going to be pushing for Vasalgel but also trying to communicate and channel the demand for new options in general, probably crowdfunding for Gandarusa or the "Clean Sheets Pill." There's strength in numbers! Watch their engaging video "The Future of Male Contraception in 60 Seconds" and then sign up with a donation (even $5 helps) to be counted as a supporter.

More questions? Check out our FAQ or join us on Facebook.

Help us complete these pivotal steps. We're working diligently and are thankful for your support!

The Vasalgel™ team

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Vasalgel, a project of Parsemus Foundation
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Albany, CA 94706-6788

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