"ChemPartner has rich experience in providing biologics discovery and development services," said Wei Tang, chief executive officer, ChemPartner. "Our exceptional scientists on our biologics discovery and development teams provide one-stop services for overall process development and IND application, and the expansion of our biologics cGMP manufacturing capacity shows we are aligned and dedicated to technically and strategically accomplishing the research initiatives of pharmaceutical and biotech companies worldwide."
ChemPartner has opened its newest facility, which is located in Qidong, China outside of Shanghai. This 67,000 square meter campus includes a laboratory center with 5,000 square meter animal facility, administration building, and biologics production plant. The biologics production plant will start operation in August 2020.
The 13,000 square meter Phase I biologics production plant complies with the highest standards and guidelines set by the ICH, FDA, NMPA, and EMPA and aims to fulfill the biologics production demands for clients globally during clinical phase III and commercial launch. This facility will accommodate up to eight 2,000 L and three 500 L single-use bioreactors as well as one 2-20 mL vial aseptic filling and freeze-drying line. ChemPartner also has well-equipped analytical facilities to support method development and product release testing.
Jun Xiang, general manager, ChemPartner Biologics, said, "Investment in this state-of-the-art biologics manufacturing facility is a major milestone for ChemPartner. This newest addition makes ChemPartner a truly world class CDMO that will continue to help our global clients bring their biologic therapeutics to the market."
ChemPartner said its biologics discovery team's experience and capabilities to discover and characterize therapeutic antibodies and fusion proteins are rapidly growing, led by western-trained PhDs and supported by ChemPartner's biology and pharmacology and DMPK and exploratory toxicology departments. Services include B cell cloning, target-specific functional assays, antibody engineering, developability and in silico assessment and protein sciences.
ChemPartner is working on projects at various clinical stages. With the expansion in services, personnel, and facilities, the seamless transition from biologics discovery to biologics development and manufacturing offers tailored services for ChemPartner's clients. The biologics CMC development and cGMP manufacturing team consists of senior scientists, engineers, and leaders with extensive experiences in process development and cGMP manufacturing.