Reducing Timelines in Early Process Development:Using a Multiparametric Clone-Selection and Feed-Optimization Strategy

摘要

The market for biopharmaceutical products remains highly attractive to small biotechnology companies and big pharmaceutical corporations alike (1). Most leading market products are made using recombinant technology (2). Pressures are continually increasing on process development groups to reduce development costs and timelines for taking new clinical products forward from product research bench scale into initial clinical evaluation studies.For many years a recognized critical bottleneck in development of products from mammalian cell lines was selection and isolation of stable, high-producing clonal cell lines. In recent years, however, clone-selection criteria have been expanded to includeproduct quality and functionality. That is driven both by regulatory demands and an explosion of interest in production of biosimilars and biobetters.