Austar provides one-stop biopharmaceutical process control system which complies with GMP, FDA and EMA requirements, involving in gene, vaccine, blood product etc. It is to guarantee product quality, improve manufacturing efficiency, lower production cost and ensure production safety by applying accurate and optimal control protocol .
Gene Engineering Process Control System
Upstream harvest: culture medium preparation and storage - cell incubation – centrifugation - deep bed filtration - harvest and CIP/SIP of each part; CIP/SIP of system.
Downstream purification: Buffer solution preparation and storage - purification 1 – Nanofiltration - purification 2 – hyperfiltration - product and CIP/SIP of each part; CIP/SIP of system