Paragon Bioservices Selected by IAVI for Manufacture of HIV Vaccine Candidate

 

BALTIMORE, Dec. 1, 2015 /PRNewswire/ – Paragon Bioservices, a global leader in the manufacturing of biopharmaceuticals and vaccines, has been awarded a contract by the International AIDS Vaccine Initiative (IAVI) for the process development, analytical development and cGMP manufacturing of a promising HIV vaccine candidate that will undergo animal and, subsequently, clinical testing.

In findings reported in June, researchers showed that an experimental vaccine candidate could stimulate the immune system to produce antibodies that, if further matured, could potentially block HIV infection in mice. The candidate’s “eOD-GT8 60mer” immunogen is a protein nanoparticle designed to mimic a critical part of the HIV envelope protein and to bind and activate B cells to produce antibodies capable of fighting HIV. The researchers showed that immunization of mice with eOD-GT8 60mer produced antibody “precursors” with some of the traits necessary to recognize and block HIV infection, suggesting that the eOD-GT8 60mer could be a good first step in a series of immunizations against HIV.

The eOD-GT8 60mer was developed in the laboratory headed by William Schief, Director, Vaccine Design at the IAVI Neutralizing Antibody Center at The Scripps Research Institute and a Scripps professor. IAVI has selected Paragon to optimize production of the eOD-GT8 60mer and characterize and then manufacture it under GMP conditions, first to test its safety and toxicity in animals and then for Phase I clinical trials.

IAVI is a global, not-for-profit organization with a mission to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. In addition to pursuing research of innovative vaccine candidates, IAVI provides product development expertise to help accelerate advancement of other leading researchers’ novel HIV candidates.

“We are honored to be a part of scientific efforts to prevent HIV, especially considering the enormous progress in the understanding of HIV transmission, immunology and vaccinology in the past few years that is bringing us closer to an effective AIDS vaccine,” stated Marco Chacon, Founder & CEO of Paragon. “Paragon has helped develop and manufacture over fifty different biotherapeutics and vaccines. Our Quality, Process Development and GMP manufacturing teams have considerable experience in the development and manufacturing of vaccine candidates—including recent contracts with the US government and ongoing contracts with biotechnology and major pharmaceutical clients.”

About Paragon Bioservices, Inc.
Paragon Bioservices is a private-equity backed contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of biopharmaceuticals—including the production and purification of monoclonal antibodies, recombinant proteins, viral vectors and vaccines. The company provides research services, process development and cGMP manufacturing. Paragon’s cGMP facilities include microbial and mammalian suites, fill-finish and fully-segregated virus facilities.

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