Contract Sample Production
Bench facilities

Our facilities is a two-story building with a floor area of 300 m2 capable of biopharmaceutical process development and sample production. This is a non-GMP facility, but it was designed with the awareness of GMP. Cultivation process related work is done on the 2nd floor and purification process related work is carried out on the 1st floor. In the upstream process, WCB is first constructed, then extended culture using flask and wave bioreactor are carried out in turn, finally main bioreactor cultivation is done. Next, cell separation by a depth filter follows this cultivation to collect culture supernatant which includes target antibodies.
In the downstream process, we usually conduct a number of chromatography steps to remove some impurities from cell culture supernatant at purification room 1. After performing the virus inactivation process and removing the virus via a filter, it is passed through a final filter in Purification Chamber 2 and then stored as a frozen or refrigerated sample.

Quality Testing
After receiving raw materials, important control processes is identified for each process up to final product production, and then quality testing settings and validation are performed.

■ Raw material acceptance test

■ Process control test

■ Product test

■ Settings of each testing method and validation

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