Next step in HIV microbicide manufacturing begins this summer

PhotoThe Biological Process Development Facility is located in Othmer Hall on the University of Nebraska-Lincoln campus.

Story and photos by Carly Shinn, NewsNetNebraska

Women in countries where AIDS runs rampant may soon get help from the University of Nebraska-Lincoln. Researchers at the school are putting the final touches on a promising cream that could protect against the HIV virus.

2011 marks the 30th anniversary of the AIDS epidemic. Since that time, treatment of the disease has evolved and advocacy and education has become more and more important. The Biological Process Development Facility (BPDF) at UNL is helping in the fight by developing and manufacturing a stable and affordable microbicide to protect women from contracting and spreading HIV.

“The HIV virus is a very complicated guy,” Michael Meager, professor in chemical and biomolecular engineering at UNL and director of the BPDF, said. “He’s got defensive mechanisms to shield himself.”

A microbicide is a compound that protects against infection. The HIV microbicide is a cream designed for vaginal application before intercourse, and the idea is to make one applicator, similar to a tampon, for the price of a cigarette.

“It’s one of the holy grails for AIDS,” Meagher said. “It will be one of multiple tools that will be used to help arrest the disease in developing countries.”

It’s unclear when the cream might go into full-scale production, but manufacturing of test doses is slated to begin by the end of this summer. The microbicide tests are being funded by the Geneva-based Mintaka Foundation of Medical Research, which received its funding from The Wellcome Trust, a global charity based in the United Kingdom. The BPDF received $3.8 million for the project.

According to the Joint United Nations Programme on HIV/AIDS, there are 33.3 million people living with HIV. 22.5 million of those people live in Sub-Saharan Africa, the area Mintaka is targeting.

“Within developed nations, you don’t hear about AIDS or HIV so much anymore,” Meagher said. “It’s not cured, but it’s relatively managed. In developing countries, that’s far from the case.”

Meagher said Mintaka selected the Nebraska facility for the microbicide production because it was impressed by the reputation of the BPDF, which specializes in the development and transition of drugs to phase I clinical trials.

PhotoFermenters are used in the process of producing and manufacturing the HIV microbicide at the facility.

“Nebraska’s not exactly biotech Mecca so to speak,” Meagher said. “But if you have these types of capabilities and you build up the academic side, you have the potential to attract the industries to do that. The goal has always been to build a facility that could compete well in that arena, but also serve as a potential catalyst for companies in the state of Nebraska and as a place to educate the students.”

This philosophy and dedication has helped the BPDF grow into one of the best academic facilities in the United States during its 21 years.

“There are two mottos around here,” Meagher said. “Failure is never an option, and every day we screw up is a day that somebody doesn’t get a needed drug that we’re working on. That’s what we live by.”

According to the U.S. Centers for Disease Control and Prevention, Nebraska is ranked 41st among the 50 states in cumulative reported AIDS cases. With the world focused on growing numbers in developing nations, it is easy to forget about those living with the disease in local communities.

The Nebraska AIDS Project is one organization that’s remembering.

NAP is the only non-profit organization working directly with HIV/AIDS clients in Nebraska. Stephanie Hummer has worked at the Lincoln branch of the project for 10 years and said she has seen a decrease in the stigma associated with HIV/AIDS during that time.

“I have seen a small difference as far as it getting better,” Hummer said. “However, there are still people out there uneducated. I had one client living with people who still made him eat off of paper plates, drink out of paper cups and use plastic utensils. It’s frustrating when you’re willing to go out and educate people and they aren’t willing to listen.”

The HIV microbicide being manufactured at the BPDF would not be available in the U.S. for many years, depending on the success of the trials in Sub-Saharan Africa. Still, there is no denying the benefits it could bring to the global community.

PhotoStephanie Hummer explains the HIV testing process at the Nebraska AIDS Project in Lincoln, Neb.

So what if the microbicide doesn’t work?

Every pharmaceutical drug or vaccine must go through clinical trials. Meagher said only one out of 10 drugs in development make it to the commercial market.

“I think the key thing is if the molecule does show efficacy against the AIDS virus,” Meagher said. “Can I say that 100 percent it’s going to work? No. But the animal studies are pretty convincing and strong in that regard.”

Meagher said early testing done at Mintaka resulted in five out of 10 monkeys being protected from AIDS. He also said the important thing to remember is that with every advancement comes more knowledge and understanding of the problem.

“Hope springs eternal,” Meagher said. “We do what we have to do. The science is the science and then it’s our job to figure out the science and make the adjustments to improve it. We’re not the end game.”

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