Manufacturing biopharmaceutical products on an industrial scale has required scaling up a variety of techniques that were previously only practiced at bench scale. This includes highly technical and notoriously difficult processes such as cell culture; maintaining living cells in a tightly controlled sterile environment.
Successful cell culture on a large scale requires close control of the culture environment in terms of temperature, pH, removal of waste products, and addition of fresh nutrients. In order to produce high yields of the desired protein, precise control over these parameters at every step in the process is required. To meet FDA requirements, stringent cleaning and sterilization is also required between each batch.