October 1, 2013 (Vol. 33, No. 17)
Improving Human Health by Providing the Highest Quality Development and cGMP Manufacturing & Testing Services
Florida Biologix is a preclinical and Phase I/II biologics contract development, manufacturing, and testing organization (CDMO) focused on a wide range of value-optimizing services, such as process development, cell banking (cGMP), vector and vaccine production (cGMP), cell and gene therapies (cGMP), upstream production and downstream purification (cGMP), fill-finish (cGMP), product testing (cGMP), and regulatory support.
About the Company
On November 15, 2006, in Alachua, FL, Florida Biologix held a ribbon-cutting ceremony to officially open the company’s brand new, state-of-the-art, multiproduct cGMP facility. This 23,800 ft2 biopharmaceutical manufacturing facility has 16,000 ft2 of classified (ISO 6–Class 1,000, ISO 7–Class 10,000, and ISO 8–Class 100,000) cleanrooms and 7,800 ft2 of supporting space for production of biologics under current Good Manufacturing Practices (cGMP).
Since that time, Florida Biologix has grown to become a leading preclinical and Phase I/II biologics CDMO committed to improving human health by providing the highest quality development and cGMP manufacturing and testing services to clients within the biotechnology and biopharmaceutical markets. Moreover, additional process development and analytical laboratory (as well as office) space has expanded Florida Biologix to 35,000 ft2.
Florida Biologix has manufactured, filled, and tested over 150 clinical product lots since 2007, including cell and gene therapies, proteins expressed in mammalian cells, and parenteral formulations. Products made in the 35,000 ft2 facilities of Florida Biologix are suitable for Phase I and II human clinical trials, which offsets common barriers to bringing laboratory discoveries to market, such as the high operating cost of manufacturing cGMP-compliant products and regulatory expertise. Florida Biologix employs 70 people, with a management team who are experts, on both a business and technical level, in biologics process development, manufacturing, and testing.
Florida Biologix offers a full-service model within the preclinical and Phase I/II stages of the drug development cycle. Client sponsors include Florida companies, start-up companies, multi-national and foreign companies, domestic private and public companies, academic scientists, and the NIH.
Florida Biologix possesses the capabilities to address client needs related to preclinical development (including materials for toxicology studies) and Phase I/II clinical production, as well as corresponding testing and regulatory support. Florida Biologix can provide a services package starting from process design and development (e.g., media screening, cell line engineering and cloning, and production and purification optimization) through full-scale cGMP-compliant manufacturing (via various disposable systems), purification, and aseptic filling. Additionally, Florida Biologix can work with clients to develop customized programs based on each client’s specific needs.
Capabilities include 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), purification, aseptic filling (including small molecules, nucleic acids, and proteins), cell therapies, product testing, and regulatory support.
To ensure excellent service, the in-house quality department of Florida Biologix provides a full range of analytical capabilities, facility and systems monitoring, product review and disposition, and regulatory support, including CMC and DMF preparation. In addition to quality assurance and control, each client is assigned an experienced project manager, who coordinates the entire process and works as the primary point of communication for the client. Combining these capabilities with state-of-the-art equipment and a senior management team with over 125 years of cGMP experience gives Florida Biologix a highly effective, synergistic approach to meeting or exceeding client needs.
Florida Biologix continues to enhance its capabilities and resources with a high level of quality and productivity. With its strong market position, Florida Biologix will remain a prime partner for new and existing clients seeking to bring the next generation of biologic medicines and therapies to the clinic.
13702 & 13706 Innovation Drive
Alachua, FL 32615
Date Founded: 2006
Number of Employees: 70