cGMP Multi-Product Production Facility
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 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 bacterial fermentation. 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.
R&D for Process Development
The initial stages of R&D are 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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Among the stages:
- Small scale R&D directed at process optimization
- Assay development for QC/in-process control testing and product release
- Development of production process
- Product characterization
cGMP Manufacturing
- Master stock preparation and cell banking
- Production of cell culture derived biologicals
- Fermentation and production of bacterial derived biologicals
- Purification / product formulation / fill and finish
- Material handling, tracking and storage / cGMP compliance auditing / validated systems
- Full QC monitoring of all stages
- QA release and document preparation
Range of Products Produced at IIBR:
- Monoclonal antibodies and antigens from cell culture
- Recombinant enzymes from animal cells
- Bacterial and viral veterinary vaccines
- Subunit vaccines
- Human and veterinary recombinant lymphokine
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