Knowledge is power in biopharmaceutical development and manufacturing. Thus, analytical methods underlie every activity from drug discovery and developability testing through production and processing to final-product formulation and lot release. Collection, management, and use of data also are key to successful market authorization of biologics across regulatory jurisdictions.
The four nominated articles in this Readers' Choice Awards category address those concerns and more for different product modalities (cell therapies, recombinant proteins, and diagnostics) and across different process stages. Means for assessing the status of cells in culture figure heavily in the winning articles. And COVID-19 rears its ugly head, as was perhaps unavoidable this year.
The Nominees: In BPI’s November–December 2019 issue, authors from Ireland and Canada report on their collaborative work at the National Institute of Bioprocessing Research and Training (NIBRT) and the University of Manitoba. They highlight the ideal state of cells in production culture and how developers can best determine viability and other aspects of that state.
In that same issue, writers representing several Sanofi facilities explained their application of a Gyrolab xP immunoassay system as an analytical platform for high-throughput HCP analysis, illustrating its comparability with the industry-standard ELISA method.
In BPI’s May 2020 featured report, an author from the University of Nottingham’s school of pharmacy highlights a promising tool for inert, long-term, high spatial and high temporal measurements of cells in culture. Applications of fluorescent nanosensors to cell and gene therapies are in the early stages of development, and their true potential is yet to be determined. But they should be able to help process engineers characterize complex biochemical processes upstream, downstream, and in situ for advanced therapy manufacture.
And in BPI’s June 2020 issue, three authors from Novateur Ventures provide a timely and thorough update of diagnostic developments for detecting the SARS-CoV-2 virus and identifying people infected and suffering from COVID-19. Accurate and rapid results play a critical role in understanding the disease, selecting appropriate treatments, controlling pandemic spread, and developing informed back-to-work policies.
BPI's congratulations go out to all the nominees this year — and especially to the winner and runners-up highlighted herein!
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