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Merck

Cost-effective production of a vaginal protein microbicide to prevent HIV transmission.

Proceedings of the National Academy of Sciences of the United States of America (2008-03-05)
Koreen Ramessar, Thomas Rademacher, Markus Sack, Johannes Stadlmann, Dimitris Platis, Gabriela Stiegler, Nikos Labrou, Fritz Altmann, Julian Ma, Eva Stöger, Teresa Capell, Paul Christou
RESUMEN

A series of small-molecule microbicides has been developed for vaginal delivery to prevent heterosexual HIV transmission, but results from human clinical trials have been disappointing. Protein-based microbicides, such as HIV-specific monoclonal antibodies, have been considered as an alternative approach. Despite their promising safety profile and efficacy, the major drawback of such molecules is the economy of large-scale production in mammalian cells, the current system of choice. Here, we show that an alternative biomanufacturing platform is now available for one of the most promising anti-HIV antibodies (2G12). Our data show that the HIV-neutralization capability of the antibody is equal to or superior to that of the same antibody produced in CHO cells. We conclude that this protein production system may provide a means to achieve microbicide ingredient manufacture at costs that would allow product introduction and manufacture in the developing world.