cGMP Contract Manufacturer Florida Biologix® Expands Fill Finish Space By 50%

Florida Biologix, a non-profit cGMP biopharmaceutical contract manufacturing organization, recently expanded their total fill and finish area by 50% to increase capacity and improve filling services. The new area is a dedicated module which allows more space for post-fill processing, labeling, inspection and packaging. They also added new equipment, such as repeat pipettors, a Flexseal 10 semi-automatic crimping machine and a Sartocheck 4 Integrity Tester. "The new space and equipment are important for us to better fulfill client needs for our formulation and aseptic cGMP fills" explains Linna Lim, the Director of Operations. The fully validated multi-product cGMP facility has an ISO 6 fill suite in which fills occur in ISO 5 vertical laminar flow stations. Ms. Lim reiterated, "The suite, our quality systems and the experience of the fill team ensure a high quality fill."

Florida Biologix has more filling capacity than most CMOs of its size and has conducted multiple media fill validations for both automated and manual fills. Each media fill validation is renewed at least annually. The automated filler produces up to 4,000 standard glass vials per day (includes vial washing, filling, stoppering and inspection). In addition, up to 3,000 final containers (cryovials, conical tubes, bags or syringes) can be filled per day manually. The experienced fill team can also work with clients to suggest ways to optimize efficiency and reduce costs when planning how to formulate and fill a protein biologic, oligonucleotide, peptide or other bulk material.

SOURCE: Florida Biologix