Experienced in a wide range of recombinant protein processes, including antibodies, fusion protein, enzymes and vaccines, CMAB's scientists are particularly experienced in early stage product process development for fast-track development into IND filing and clinical phase I/II/Ⅲ manufacture. We work with our Clients to define the preliminary targeted product profile (TPP), identify phase appropriate critical quality attributes (CQAs), and conduct early assessment of potential critical process parameters.
A systematic approach in risk analysis and quality by design is a standard in our process development activities. Through Design of Experiment (DoE), our scientists will help determine the design space for the process from initial stages to late stage development and anticipate the process control/validation throughout the product life cycle.
Our services are coordinated by CMAB's Project Managers to transfer in new products, progress through development, and deliver reports and products on time.