Manufacturing
Manufacturing
Ausgenex’s single use sterile facility is a state of the art, GMP compliant facility for sterile filtration of our serum products supplied internationally.
The facility boasts a large batch size capability at 3000L for a single, true pooled batch
The manufacturing process of fetal calf serum involves collecting blood from fetal calves. The blood is then centrifuged to separate the serum from the blood cells, followed by filtration to remove any remaining particles.
Utilising the newest filtration technology available ensures the highest quality products, consistently.
Ausgenex uses a purpose built, automated sterile dispensing machine within its filtration facility to ensure the highest level of sterility. The dispensing and production lines are fully automated through bottling, labelling and tamper sealing allowing for large batch size production with consistent quality.
Production control and batch records are electronic using the latest GMP certified software at a level normally reserved for large pharma companies. This system drives the entire Ausgenex facility, manufacturing and quality control.
The serum undergoes heat inactivation to eliminate complement proteins and undergoes sterilization to ensure it’s free from contaminants. After rigorous quality control testing for sterility, protein levels, and safety, the serum is packaged in sterile vials and stored at low temperatures until it is distributed for use in cell culture and research applications.
