cGMP Bulk Biologic Substance Production By Florida Biologix

Florida Biologix's staff and state-of-the-art equipment generate the highest quality bulk material.

cGMP BULK SUBSTANCE SUITES:

The three ISO 7 production modules are configured to facilitate the transfer of production harvests into either of the two downstream purification suites through inter-room transfer ports.

Suites have unidirectional flow of material and personnel, dedicated gown-in and gown-out rooms, single pass air supply with independent HEPA filtration and 80 air changes an hour.

Large-Scale cGMP Production: Upstream Cell Culture: Florida Biologix can produce cell culture supernatants or lysates containing the target biologic for downstream purification. The various production methods include a state-of-the art 2 x 200L disposable stirred tank bioreactor, flat stock (cell factories or roller bottles), or small-scale Wave bioreactors.

Cell therapy products: Highly experienced cell culture scientists at Florida Biologixprocess parenteral products for cell therapy. Cells can be cultured, expanded and harvested for cellular therapy applications. Large numbers of cells can be produced under cGMP regulations in the large-scale ISO 7 production module.

Downstream Purification and Processing: State-of-the-art equipment purifiesand further processes the target biologic. Florida Biologix offers:

• Concentration and buffer exchange - Millipore Cogent Tangential Flow Filtration system
• Chromatographic purification (affinity, molecular sizing, anion/cation elution) of the target biologic using the AKTA Pilot system
• Viral inactivation and nanofiltration

IN-HOUSE QUALITY CONTROL AND QUALITY ASSURANCE: QC provides facility environmental monitoring procedures and a full battery of analytical methods. QA provides audited Production Batch Records, product release and other appropriate regulatory documentation