Chapter 13: Formulation Development for Biologics Utilizing Lab Automation and In Vivo Performance Models
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Formulation scientists are confronted with challenges arising from the increasing diversity of molecule formats and their functionality such as antibody-drug conjugates, fusion molecules, as well as increasing expectations by authorities for an in-depth product and process understanding (Quality by Design concept). However, the very same disruptive technological advancements that enable protein engineers to design and produce such novel molecule constructs can be utilized to improve formulation development. In particular, innovations in lab automation and system integration in conjunction with method miniaturization allow for generating more data more efficiently. Furthermore, software tools developed to cope with “big data” and data science enable automated data management and processing to master the ever-increasing amount of data. Finally, in order to allow for a science-based assessment of analytical results, adequate in vivo models are required to assess the respective biorelevance, like chemical modifications.
KeywordsQuality by Design High-throughput laboratory Automated liquid formulation screening Microplates Antibody Miniaturized analytical methods Stability studies Data management Biorelevance In vivo performance models Protein metabolism
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