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IIBR`s
biotechnology activities draw on more than 30 years of
experience in advancing research from the laboratory scale
to pilot scale production.
The modern cGMP biopharmaceutical facility 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 the high specific 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 bacterial fermentations. Downstream processing
includes a variety of unit operations, including cell disintegration,
and clarification by centrifugation or microfiltration.
Final purification includes ultrafiltration, chromatography
and freeze-drying. The facility is built to meet BL2-LS
criteria, and cross contamination between suites is avoided
by using separate HVAC systems. Strict change control
and cleaning (automatic SIP/CIP) between processes is
performed. Purification steps are performed in clean rooms
of classes 100,000 and 10,000. Aseptic final vial filling
and lyophilizer loading is done in a class 100 clean room. |
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R&D
is conducted in separate laboratories equipped with small
fermentors and a variety of equipment to cover all aspects
of analysis, cell culture, fermentation and product purification. |
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R&D
and Process Development |
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Small scale R&D directed at process
optimization
Assay development for QC/in process
control testing and product release
Process development
Product characterization |
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Range
of Products Produced at IIBR |
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Monoclonal antibodies and antigens
from cell culture
Recombinant enzymes from animal
cells
Bacterial and viral veterinary vaccines
Subunit vaccines
Human and veterinary recombinant lymphokines |
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