ChemPartner’s biologics CMC business is provided under China Gateway Biologics (Shanghai) Co. Ltd., a wholly owned subsidiary of ChemPartner and established in July 2015. We provide services seamlessly following the early discovery stage, and move onto biologics CMC development and GMP manufacturing to support overall IND and NDA application requirements and beyond for clients. Our one-stop shop service covers stable cell line development, process development and GMP production from cell culture, purification, to aseptic filling and lyophilization at pilot-scale and commercial level.
We are comprised of senior scientists, engineers and leaders with extensive process development and GMP manufacturing experiences within various fields of biopharmaceutical industry. We serve customers all over the world following the highest quality standards of FDA, EMA, CFDA and ICH guidelines. Our mission is to become a trusted partner for our clients’ success.