Emerging Technologies in Facilities of the Future
Continuous Bioprocessing Platform
Continuous processing is not new to the pharmaceutical industry. Today, the majority of major pharmaceutical companies at least consider continuous processes when developing new small-molecule entities. In contrast, the biopharmaceutical industry has been slow to adopt continuous platforms, particularly related to high volume processes. This reticence can be attributed to a number of reasons. The risk adverse nature of the industry, Regulatory uncertainties, the impacts of the shift from traditional batch processing, and the technical challenges, particularly regarding the development of analytical technologies that can enable at-line/on-line real time monitoring. However, focus on continuous bioprocessing is increasing. Over the past few years, the FDA has become more active in its support of continuous manufacturing, primarily because it recognizes that continuous processing has the potential to reduce drug development and commercialization times, which would obviously be a major benefit to both the industry and ultimately the patient.