SciGen's first GMP facility is located in Rehovot, Israel, adjacent to the world renowned Weizmann Institute. This location enhances SciGen’s scientific collaborations and provides a vast source of knowledgeable staff.
The facility serves as a center for two major activities of SciGen:
- Operation unit for the production of proteins derived from recombinant mammalian cells. The first product in this facility is Sci-B-Vac, the Company's third generation vaccine for hepatitis B produced in bioreactors by Chinese Hamster Ovary cells. All the manufacturing activities, starting from the cell bank to the filled vial or syringe are performed in-house.
- SciGen’s Research & Development unit led by well experienced scientists is the Company's center for developing the next generation products and supporting the current products in its various sites.
The facility has undergone a successful inspection by the Israeli Ministry of Heath in October 2007, and additional inspections by other regulatory authorities, such as the EMEA, are expected in 2008.
The facility occupies at present 1700 sq. meters and is currently undergoing an expanding process that would allow an increased production capacity.
SciGen Biopharma Pvt Ltd ---- the Indian arm of SciGen Ltd., Singapore
Situated amongst the gently rolling green hills of the South-Western Indian city of Pune, 130 kms from Mumbai, the Indian biopharmaceutical facility of SciGen Ltd, aptly named SciGen BioPharma Pvt Ltd is steadily taking shape to be a one-of-its-kind manufacturing plant for therapeutic proteins in India.
Spread over a 440,000 sq. ft. green field, the plant, when finished, would comprise of
- Manufacturing Building of 25,000 sq. ft.
- Utilities spread over 47,000 sq. ft.
- a state-of-the-art Process Development Lab of 750 sq. ft. complete with modular Clean Room and Aseptic design
- a fully equipped QC Lab of 2,500 sq. ft. and
- administrative office complex of 15,000 sq. ft. The Manufacturing Plant would house capabilities to produce both microbial as well as mammalian derived biopharmaceuticals from cell lines through to fermentation right up to sterile grade bulk crystals or concentrates.
When commissioned, the Plant would have the capacity to purify 7,500 liters of microbial broth right up to crystals and would have a cumulative capacity of 40 liters of mammalian fermentation. The plant is being built to standards conforming to EMEA and US FDA.
This Indian Facility of SciGen is a 100% Export Oriented Unit and would offload its total produce to its parent company SciGen Ltd., Singapore for further downstream packaging. The therapeutic proteins that have been earmarked for immediate manufacture are r-Hu Insulin, r-GCSF, Hep B and Alfa-Interferon.
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