Bio-Thera Solutions, Ltd.,

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Process & Manufacture

We have completed construction and put into use in two 3,500L stainless steel bioreactors, three 500L single-use bioreactors, three 2,000L single-use bioreactors, four 4,000L stainless steel, and one 200L ADC drug coupling reactor. There are various filling lines accommodating products for different formulations. Our quality management system comply with GLP, GCP, and cGMP. Our production quality management system has been certified by China NMPA, US FDA, EU QP, Brazil ANVISA and other international inspections.