Florida Biologix Meets EU Compliance

Florida Biologix has met European GMP requirements for aseptic fill-finish for biopharmaceutical drug products. The company can now provide aseptic fills for European clinical trials for filling Phase I/II drug products into vials or other containers.

Florida Biologix provides either manual or automated filling services of as much as 4,000 vials per lot, including formulation and filling of complex biologic products such as proteins, protein complexes, adjuvanted vaccines, oligonucleotides, liquid small molecules and other parenterals. Associated services include drug product in-process and release testing, labeling, packaging, cGMP storage, stability studies, blind labeling, and distribution to clinical study sites.

In addition, the company has recently invested in GMP facility improvements and equipment, as well as additional classified support space and is adding new warehouse areas. The associate director of Florida Biologix, Dr. Joyce Francis, said, “These improvements support our multi-year production contracts. As our business grows, we continue to make investments to improve our state-of-the-art facility and overall capabilities.”