Bulk Substance Production (cGMP)

We have experience with all types of mammalian cell lines, including stem cells. Our highly experienced cell culture scientists are also capable of processing allogeneic, parenteral products for cell therapy.

The Florida Biologix® manufacturing facility has been designed and built to accommodate simultaneous production of multiple products. The ISO 7 (class 10,000) production modules are configured to facilitate the transfer of the cell culture harvests into purification suites with minimal manipulation.

Upstream Cell Culture

Florida Biologix has in-house expertise and experience to produce small-scale cell culture supernatants or lysates containing a target biologic. The various production methods offered include:

• 2X200L Disposable Stirred-Tank Bioreactor
• Roller Bottles
• Hollow Fiber Systems
• "Cell Stack" - for adherent cell lines
• Other Disposable System Bioreactor (small scale)

Downstream Purification and Processing

We use state-of-the-art equipment to purify and further process the target biologic. The services offered include:

• Chromatographic Purification of Proteins and Peptides
• Diafiltration and Other Membrane Filtration Technologies for Concentration and Buffer Exchange
• Formulation and Nanofiltration

Please contact us for more information. Project specific proposals are provided upon request.