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Measurement of impurities to support process development and manufacture of biopharmaceuticals

Oshinbolu, S; Wilson, LJ; Lewis, W; Shah, R; Bracewell, DG; (2018) Measurement of impurities to support process development and manufacture of biopharmaceuticals. TrAC Trends in Analytical Chemistry , 101 pp. 120-128. 10.1016/j.trac.2017.10.026. Green open access

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Abstract

The biopharmaceutical industry is a growing market relying on analytical methods to bring safe and efficacious drugs from conception to market. Analytical methods are required during the entire drug life cycle as it plays a vital role during decision making. Impurities influence product quality, stability and efficacy, so their levels need to be minimised. There are regulatory guidelines that set out principles for consideration in meeting product quality specifications. Analytical methods have limits in their sensitivity and accuracy of measurement, their sample throughput and/or range of detection. This highlights the need to have orthogonal assays that can confidently quantify critical impurities to the appropriate levels. In this review, we discuss three major analytically challenging critical quality attributes – two product related impurities (aggregates and incorrect glycosylation) and one process related impurity (host cell proteins) – and the analytical assays that are commonly used to measure their quantity and quality.

Type: Article
Title: Measurement of impurities to support process development and manufacture of biopharmaceuticals
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.trac.2017.10.026
Publisher version: https://doi.org/10.1016/j.trac.2017.10.026
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Recombinant therapeutics, Aggregation, Host cell proteins, Glycosylation, Regulation, Biopharmaceuticals
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/10071100
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