When a project enters the clinical trial phase, it is then time to consider the eventual need for mass production. Our company’s technical group possesses great experience in the production of biological macromolecular drugs and in-depth understanding of all possible scenarios that may be encountered on the production floor. We are capable of effectively controlling the risk of going through process scale-up and mass production.

      Late stage development, besides process characterization and scale-up, also involves engineering related to manufacturing equipment and facilities. This process involves the design of the process flow of the product, development of user requirement specifications and procurement of key equipment; as well as equipment installation and commissioning, and validation activities. Our team has led the design of a large molecule biologic drug manufacturing facility at a 12000L scale, and three such facilities at a 3000L scale. We have also provided consulting services for some pilot plant facilities.