Upstream Chemistry Analysisin Cell-Based Process Development:Advantages of Minimization

摘要

Cell line selection is important to any pharmaceutical company's development pathway for biological compounds (l). In cell-line selection laboratories, many different, slightly variable cell lines are tested in parallel for desired characteristics. Candidate cell lines are chosen for further development on the basis of their performance in basic tests of critical quality attributes (CQAs).Historically, such cell lines were selected in large-volume containers because it was necessary to have sufficient volume in culture to allow repeated sampling without damaging the culture (2). In new, small-scale bioreactors with 10-mL total culture volumes, removing even half a milliliter five times for parameter testing represents a total loss of 25% of culture volume. Such a change will dramatically affect the behavior of cells in culture (2).