Florida Biologix, with a proven track record of successful biopharmaceutical cGMP manufacturing campaigns and drug product fills for US clinical trials, announces that it now meets European GMP requirements for aseptic fill and finish. These enhancements provide companies seeking high-quality aseptic fills for European clinical trials an outstanding and cost competitive provider for filling Phase I/II drug products into vials or other containers.
Florida Biologix provides either manual or automated filling services up to 4,000 vials per lot. They have significant experience with 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 to this expanded capability, Florida Biologix has recently invested in GMP facility improvements and equipment, as well as outfitted additional classified support space and is adding new warehouse areas to better serve clients’ needs. The Associate Director of Florida Biologix, Dr. Joyce Francis, explains, “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.”