We deliver on time, as promised and at top quality
Alfa CDMO provides MCB, WCB, and EOPCB banking service in compliance with European EMA, and Chinese NMPA GMP regulatory requirements.
Alfa CDMO offers manufacturing services including cell culture by using disposable bioreactors, purification, formulation, fill/finish (both liquid and lyophilized) and package of drug product. State-of-the-art equipment ensures product to be consistently produced with high quality.
Alfa CDMO is the one of the leading companies for ADC drug development in the world that provides technically challenging service from development to commercial production including both payload and ADC. Alfa CDMO is equipped with state-of-the-art fill/finish equipment with aseptic filling and lyophilization with automated operation to ensure manufacturing with efficient control. Innovative linker/payload technologies are implemented to ensure product with good therapeutical window and safety. Robust ADC manufacturing process produces ADC with consistent drug to antibody ratios (DAR).
Product testing/release, specification setting are based on EMA, NMPA filing principles and ICH guidelines and life cycle management.