Publications by authors named "Chie Hashikawa-Muto"

Article Synopsis
  • - Virus filtration is crucial for ensuring the safety of monoclonal antibodies and other biotherapeutics, with filters like Planova playing a key role in virus retention and performance indicators for high-throughput processes.
  • - Limited information exists on the filtration characteristics of Planova filters, particularly the differences between Planova 20N and Planova BioEX, highlighting the need for comparative studies.
  • - This study examined the filterability of the two Planova filters using various feed solutions, revealing that factors like feed solution viscosity and mAb aggregate content significantly affect filterability performance.
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Viral safety is a critical concern with regard to monoclonal antibody (mAb) products produced in mammalian cells such as Chinese hamster ovary cells. Manufacturers are required to ensure the safety of such products by validating the clearance of viruses in downstream purification steps. Cation exchange (CEX) chromatography is widely used in bind/elute mode as a polishing step in mAb purification.

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