Discussion

To be successful in the new quality-by-design (QbD) manufacturing environment, the biopharm industry requires ever greater understanding of how critical process parameters impact critical quality attributes (CQAs) and in turn, how these impact product performance in a clinical setting. To aid deliver this multi-dimension knowledge space, the last decade has seen an explosion in high throughput automation dedicated to biopharmaceutcial development. Consequently, the industry could now be on the cusp of the ‘meaningful terabyte’ product file. This presentation will introduce the audience to this paradigm shift in how smart automation and joined-up big data sets will form the future of Biopharmaceutical industry.