Gene Therapy Review: Gene and Cell Therapy Resource
cGMP CMO Florida Biologix® Announces EU Compliant Aseptic Fill-Finish and Facility Enhancements for Biopharmaceutical Drug Products
- Written by Chris Aytug
2 February, 2012. Alachua, FL: 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 provides 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 client’s 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.”
About Florida Biologix
Florida Biologix® is a Phase I/II biologics contract development, manufacturing and testing organization that offers a range of biopharmaceutical services to the biotechnology industry and research institutes. They provide exceptional customer service, close project collaboration, and clear and honest communication. Florida Biologix’ in-house quality departments reside within the 23,000 square foot, state-of-the-art GMP facility, designed for multi-product bulk substance manufacturing, cell therapy product manufacturing and aseptic vial filling; an adjacent building houses the 5,000 square foot process development laboratories.
Florida Biologix staff are not only experts in biologics manufacturing, based on a foundation of science and engineering, but are also approachable, trustworthy, and believe that the best way to build long-term relationships with clients is through open communication and on-time delivery.
Chris Aytug, MBA
Director of Marketing and Sales
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