Florida Biologix

Florida Biologix® is a Preclinical and Phase I/II biologics contract development, manufacturing, and testing organization focused on a wide range of value-optimizing services, including: cell line engineering, cGMP cell banking, process development, assay development, cGMP vector/protein production in mammalian and insect cells (including monoclonal antibodies, recombinant proteins, enzymes, vaccines, gene transfer vectors, and other biomolecules), cell therapies, purification, aseptic filling (including small molecules, nucleic acids, and proteins), product testing, and regulatory support.

Florida Biologix® has manufactured and tested over 155 clinical product lots since 2007, including cell and gene therapies, proteins expressed in mammalian cells, and parenteral formulations. Products made in the 36,000 sq. ft. facilities of Florida Biologix® are suitable for Phase I and II human clinical trials, offsetting common barriers of bringing laboratory discoveries to market, such as the high operating cost of manufacturing cGMP-compliant products and regulatory expertise. Florida Biologix® employs 65 industry-experienced personnel who are experts, on both a business and technical level, in biologics manufacturing. Client sponsors include Florida companies, start-up companies, multi-national and foreign companies, domestic private and public companies, academic scientists, and the NIH.