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.