Advancing research from laboratory scale to pilot production scale.
The modern cGMP biopharmaceutical facility at IIBR is operated by highly-experienced scientists and technicians and is designed to meet international regulatory guidelines for the production of biopharmaceuticals and vaccines. Final products are designed to meet rigorous requirements for use in Phase I and II clinical trials.
The multi-product biopharmaceutical production facility consists mainly of two modern computer-controlled fermentors of 1200L and 500L, used either for mammalian cell cultures or for microbial fermentation. Downstream processing includes a variety of unit operations, including cell disintegration, and clarification by centrifugation or microfiltration. Final purification includes ultrafiltration and chromatography. The facility is built to meet the BL2-LS criteria, and cross-contamination between suites is prevented by using separate heating, ventilation and air conditioning (HVAC) systems. Strict change-control and cleaning (automatic sterilization/cleaning-in-place [SIP/CIP]) are performed between processes. Purification steps are performed in clean rooms of classes grades C and B. Aseptic final vial filling is done in a grade A clean room.
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