With $3.8 million in new funding from the Mintaka Foundation of Medical Research supported by the Wellcome Trust, the University of Nebraska-Lincoln Biological Process Development Facility is developing a process to manufacture a stable and affordable microbicide to protect women from contracting and spreading HIV.
The contract is one of the largest and the latest to the university's Biological Process Development Facility. Over the next two years, the facility will develop a process and manufacture the microbicide, 5P12-RANTES, that can be administered to women in a vaginal cream for resisting HIV transmission.
The Mintaka Foundation, located in Geneva, Switzerland, received funding for the project from the Wellcome Trust, a global charity based in the United Kingdom.
The Biological Process Development Facility is taking the molecule discovered by Mintaka's scientists and will develop all aspects of the process to manufacture the product efficiently and safely. The facility uses fermentors — vessels which allow for large quantities of protein to be produced using either a bacteria and yeast — as the "production team." The scientists will then use a series of steps to purify the protein to a level suitable for human clinical trials. The facility will then manufacture the microbicide for the first human clinical study.
"Having an effective microbicide against the AIDS virus is one of the 'holy grails' for limiting the spread of the disease," said Dr. Robin Offord, the Mintaka Foundation's executive director. "Although developed countries have made great strides in prevention, more than 95 percent of the new infections — still running at about 2.5 million per year — occur in poor countries. Moreover, in Africa south of the Sahara, 75 percent of the young people being infected are female. Mintaka is particularly happy to be developing a prevention method which can be used under the woman's own control.
"Although the molecule is the result of high-tech research, it is hoped that the product will cost no more per dose than the equivalent of a few U.S. cents, and we are particularly grateful to the Biological Process Development Facility for its enthusiastic adoption of the goal of finding the most economical production method possible, while not departing in any way from the highest possible quality standards. We could have entrusted this work to any of the world's best contract facilities, the several months of our active collaboration with the Biological Process Development Facility have shown that we could not have made a better choice."
"The Biological Process Development Facility has a motto that every day counts in the lives of patients needing this drug," said Michael Meagher, facility founder, director and Donald F. and Mildred Topp Othmer professor of chemical and biomolecular engineering at UNL. "Each day we can save from the project is one day earlier a patient receives a life- changing therapy. This is absolutely true as we are the ones making the biotherapeutic that will be administered to the patients. With this project, the impact is very significant given the potential of 5P12-RANTES and the desperate need for cost-effective HIV microbicide," he said.
For nearly 20 years, now with a staff of 29 scientists, engineers, and administrative personnel, the UNL Biological Process Development Facility has been recognized as a leading research facility in the development of vaccines and therapeutic agents. The facility recently opened its $11.2 million cGMP manufacturing pilot plant on the first floor of Othmer Hall with more than 6,000 square feet of cleanroom space and another 7,000 square feet of support space in the basement. The Biological Process Development Facility has the expertise to transition a biotherapeutic from discovery into the clinic, including all aspects of process development including molecular biology (strain development), fermentation, purification and analytical methods, regulatory, process scale-up and manufacturing of the product for clinical testing under current Good Manufacturing Practices as mandated by the Food and Drug Administration.
The facility has worked with the federal government, commercial and nonprofit entities helping to bring their molecules to reality, including developing processes and manufacturing vaccines against bioterrorism agents such as botulism, ricin and anthrax. The facility has also been instrumental in helping 14 different biotherapeutics to transition into clinical testing to combat diseases such as cancer, hookworm, vascular disease and multiple sclerosis.
The Wellcome Trust is a global charity dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.