Summary   Comparison of a complete MAb purification process from a 100-L cell culture volume demonstrated a 50% reduction in process time using the ReadyToProcess platform instead of traditional process equipment. The decrease was made possible by elimination of column packing and testing, membrane wetting and rinsing, system cleaning, cleaning validation, and so on. Additionally, the ReadyToProcess run required less hardware and thus generated a smaller footprint. Both chromatography steps were run on one system using disposable, exchangeable flow…

          Influenza virus vaccines have traditionally been produced by infection of fertilized hen eggs. This labor-intensive approach requires large facilities, which has led to the development of large-scale mammalian cell culture methods for future virus vaccine production processes. The main focus of these studies was to use generic, established, and scalable techniques for industrial production of live influenza vaccines (Figure 1) and potentially also for other viruses independent of type or size. Development of three different…

          Water is a key raw material used in manufacturing products within the healthcare, pharmaceutical, and biopharmaceutical industries. Microorganisms found in these water systems are mainly stressed, slow-growing strains characterized by long incubation times (five to seven days) before growth can be detected using traditional microbiology methods such as membrane filtration or pour plates. That time required before contamination can be detected in water can cause delays in product release and extend the storage time of…