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3 NEW FDA APPROVED BIOREACTORS FOR DIAGAST
On January 31st, DIAGAST has received the FDA approval for the use of 3 additional bioreactors (65, 250 and 380 liters) in the manufacture process of monoclonal antibodies. These 3 "FDA Approved" bioreactors join the 3 existing bioreactors (30, 80 and 320 liters) that have already received the FDA approval in 2008.
This approval is the result of a long term work of our Cell Culture, Operations and Quality Assurance services. Indeed, bioreactors have been controlled to obtain the following validations:
- Installation and Operational Qualification
- Operational PerformanceQualification (3 successive cultures)
- Sterilization process Qualification (3 sterilizationcycles)
- Cleaning process Qualification (3 cultures)
This new park of six "FDA approved" bioreactors allows more flexibility in cell cultures planning, in concentrated bulks management and in the reagent manufacture in general. Indeed, cell cultures can be launched in each "FDA approved" bioreactor whatever their destinations and their targeted markets.
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