Continuous Manufacturing Progress and the Bio/Pharmaceutical lndustry'Reality or Fad'

摘要

The importance and value of modular continuous processing technologies to provide economic and sustainability advantages means that the industry is able to adapt more rapidly to changing market demands. Factors other than scientific are the barriers to change from batch to continuous production. The bio/pharmaceutical industry has reached a stage that requires a change in the production paradigm. For certain classes of biopharmaceutical products upstream continuous manufacturing has always been applied: for example, unstable proteins that rapidly degrade in the culture broth. In order to obtain a high quality product, the residence time in the reactor must be minimized. This can only be achieved with continuous cultivation and preferably with perfusion reactors. Furthermore, this is a universal production platform that can be extended to other classes of products, such as antibodies, which are relatively stable molecules. Continuous manufacturing is as productive and with a much smaller footprint of the manufacturing plant, avoiding multiple non-value added unit operations. In essence, the investment for a continuous plant is much smaller compared to a batch-operated one.