In recent years the number of biotherapeutic molecules requiring more complex assemblies has greatly increased. Typically, these multi-chain molecules are no longer compatible with platform approaches and require a more flexible and agile approach to early developability and method development. Lonza have developed a Toolbox approach using in silico tools, vector design/screening and analytical method development to de-risk process development and manufacturing. This toolbox approach allows us to screen for titre and product assembly at an early stage of development.
Authors: Rebecca Michael, PhD Principal Group Leader, Cell and Molecular Biology Group and Karl Rogerson Senior Principal Scientist, Global Process and Analytical Development Sciences