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Alachua, FL - Florida Biologix, a non-profit biopharmaceutical contract manufacturing organization (CMO), has signed contracts for aseptic fills for several biopharmaceutical industry clients in the 3rd quarter of 2008. These contracts include filling a monoclonal antibody as well as filling a specially formulated vaccine (which includes assay development and engineering runs).

For a Phase I/II scale CMO, Florida Biologix has an excellent filling capacity (up to 4,000 vials/day) supported by stringent quality systems, an experienced fill team and in-house quality control. Therefore, clients are very happy with the scheduling, pricing and the results of their clinical fills, rating Florida Biologix as a 4 or 5 (out of 5) on customer satisfaction surveys.

Director of Operations, Linna Lim explains "we have never had any contamination issues in over 30 cGMP fills over the past 2 years and we have multiple return clients who appreciate our flexible schedule, excellent customer service and very competitive prices". "We can even meet EMEA specifications for our fills which provides a valuable service for clients with clinical trials in European countries".

Florida Biologix provides biopharmaceutical cGMP manufacturing services from process design and development (media screening, cell line optimization and cloning, production & purification optimization) through full-scale GMP compliant manufacturing (various disposable systems), purification and aseptic filling.

SOURCE: Florida Biologix