Manufacturing Facility

Florida Biologix^® has a state-of-the-art 23,500 square foot multi-product validated biopharmaceutical manufacturing facility which will house 16,000 square feet of ISO 6, ISO 7, and ISO 8 clean rooms and supporting space for production of biologics under the current Good Manufacturing Practices (cGMP).

The senior technical management of Florida Biologix^® has a combined experience of over 90 years in cGMP production of biologics and vaccines for phase I and phase II clinical trials.

The manufacturing facility has a unidirectional flow of personnel, materials, and equipment, all suites with dedicated gowning and degowning rooms and consists of:

Two spatially segregated ISO 7 cell banking suites that are capable of preparing multiple cell banks simultaneously.
One ISO 7 in vitro production-harvest suite.
Two ISO 7 downstream purification suites that are capable of handling two products simultaneously.
One ISO 6 aseptic fill and finish unit, precisely designed with air pressure differential cascade from the core outwards. This unit is equipped with two ISO 5 (class 100) vertical laminar air flow hoods, an automatic liquid fill station, and spatially segregated ISO 5 sealing and crimping stations.
ISO 8 buffer preparation and weighing rooms
ISO 8 clean and return corridors
One ISO 8 assembly, inspection and packaging room. This unit contains a validated Sencorp Cera Tek Model 12-AS/2 heat sealer for pouches, two (2) fluorescent magnification lamps, adequate floor and table space for packaging, labeling, and inspecting product prior to storage and shipment.

Click here for a video walk-through of our facility.