Reduce Cost, Increase Quality, And Shorten Cycle Time In Upstream Manufacturing Scale Cell Culture With A Single-Use Heat ExchangerSource: ASI Life Sciences
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.
Large-scale cell culture is typically performed in one of 2 ways; in the bioreactor (concentrated batch-fed), or perfusion, where fresh medium is continuously fed to the culture suspension, and metabolic waste products removed. Both process models have different economic benefits, and manufacturing companies have continued to push the limits of these technologies to reduce production scale and increase protein titers, necessitating ever-tighter control over the process parameters.