Multivariate data analysis (MVDA) has gradually emerged as a powerful, efficient and effective tool for analyzing process data that is routinely captured during the manufacturing of biopharmaceutical products. It is being increasingly used in the biotech industry. This talk will aim to present several case studies that together showcase the significant impact that MVDA can make towards bioprocess development. First case study will aim to show how process understanding can be captured from MVDA of manufacturing data. Second case study will demonstrate use of MVDA for performing root cause analysis that was required to resolve process underperformance during a technology transfer and a scale-up of a mammalian cell culture process. Third case study will show how MVDA was used for examining comparability of two processes involved with manufacturing of a microbial therapeutic product. Final and fourth case study will involve use of MVDA in analysis of data from a biotech process so as to guide process development of the next generation process for the same product. Overall, the case studies presented here demonstrate the significant role that MVDA can play in the Quality by Design paradigm. <br/>

Multivariate data analysis for biotech processes: Industrial case studies

253rd National Meeting (2017)

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