Single use technology

Abzena is the only CMO to employ single-use flexible technology throughout the production process. Our state-of-the-art multi-product facility has been designed to take full advantage of the advances in single-use technology. Our FDA-registered multi-product facility was designed specifically for single-use technology.

  • Single-use bioreactors 1L-500L
  • Class 10,000 and Class 100,000 manufacturing suites
  • Process development and Quality Control laboratories
  • Controlled materials quarantine and release storage space
  • Drug Manufacturing License from California Food and Drug Branch (CA-FDB)

The advantages of single-use technology:

  • Cell line expansion and cell banking
  • Eliminates risk of cross-contamination
  • Lower cost as a result of fewer system requirements
  • Quick turn-around time between runs
  • Less complex engineering design means faster process development
  • Single-use components are clean and ready to use when supplied, which mitigates the need for sterilisation and decreases the requirement for formerly essential services such as water for irrigation systems and steam generators. The systems are less complex, minimising engineering requirements resulting in the elimination of clean-in-place or steam-in-place operations along with the associated piping, valves, controls and pressure rating of vessels.
  • Employing single-use bioprocess technology in manufacturing allows for maximum flexibility, which reduces time to clinic for your product. With this technology, we can rapidly scale up your process from 1L to 15,000L at a lower overall cost than with traditional steel bioreactors.
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