Facility

Florida Biologix® occupies a state-of-the-art 23,500 square foot multi-product validated biopharmaceutical manufacturing facility with 16,000 square feet of classified (ISO 6 – Class 1,000, ISO 7 – Class 10,000, and ISO 8 – Class 100,000) cleanrooms and supporting space for production of biologics under the current Good Manufacturing Practices (cGMP).

Each of the manufacturing facility’s 5 classified production modules has dedicated gowning and degowning rooms for segregation of projects, and maintenance of unidirectional flow of personnel, materials and equipment:

  • 1 Cell culture module contains two segregated ISO 7 cell banking or cell therapy rooms, capable of preparing multiple products simultaneously
  • 3 multi-use cleanroom modules for mammalian cell culture production (ISO 7), other mammalian cell manipulations or purifications
  • 1 Fill-finish module for automated or semi-automated liquid vialing (ISO 6)

Also in the classified manufacturing facility are the following ISO 8 areas for production support:

  • Intermediates storage room
  • Buffer preparation room
  • Labeling and packaging room
  • Preparation room (for supply sterilization process)
  • Sterile room (storage for sterilized supplies)
  • Decontamination room (waste handling)

The facility also houses modern quality control laboratories equipped with advanced equipment to perform a variety of tests. The warehouse has separate receipt, quarantine, release and storage of raw materials rooms, as well as product quarantine and release and shipping rooms.

The Florida Biologix facility uses technically advanced process equipment, including:

  • Fully validated REES Centron Environmental Monitoring system, which monitors the facility and its process equipment around the clock
  • Gruenberg depyrogenation oven
  • Getinge cGMP autoclave with steam to steam generator, fed with polished RO/DI water that exceeds the USP type I water specifications
  • Automatic liquid fill machine
  • AKTA Pilot Chromatography skids and collectors
  • Millipore Tangential Flow Filtration skids
  • CO2 incubators, refrigerators, freezers, medical gas distribution system, and other peripheral process equipment