Antibody production platform processes have been widely adopted in biomanufacturing, but many unit operations are not suitable for integration and automation. Here we describe the work of integrating unit operations by transforming a column operation to a more robust cassette format. We have selected a biomolecule-friendly buffer (phosphate) to eliminate, or delay, the performance of a circulating tangential flow ultrafiltration/diafiltration (UF/DF) operation, so the harvest-to-purified-bulk process can be integrated, resulting in a single, direct-flow operation, that reduces the batch process time from about two weeks to six hours. Antibody production platform processes were established in the late 1990s. In the past 20 years, biomanufacturers have been using engineered Chinese hamster ovary (CHO) and NS0 cells to produce antibodies, bispecific biomolecules, and other fusion proteins. Figure 1 shows the current platform process. Click Here For Complete Article Text
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