Drug Substance (DS) Manufacturing

Mammalian Cell Culture & Harvest

Core competencies:

Four independent production lines of total 38,000L;

Compliance with international cGMP standards;

State of the art stainless steel bioreactors and centrifuges;

Full automated clean in place (CIP) and sterilization in place (SIP);

Continuous centrifugation and disposable depth filtration;

Highly automated operation to minimize product contamination.

Downstream Process for Drug Substance

Core competencies:

Chromatography columns up to 1.4m in diameter;

Individual chromatography skids for four plants;

Customized Skids for virus inactivation, virus filtration and UF/DF;

Pre- and post-viral segregated design;

Dedicated bulk fill suite;

Full automated clean in place (CIP) and sterilization in place (SIP);

Highly automated operation to minimize product contamination.