High-Throughput, Fluorescence-Based Esterase Activity Assay for Assessing Polysorbate Degradation Risk during Biopharmaceutical Development.

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Abstract

Hydrolytic degradation of polysorbate during 2-8°C storage of monoclonal antibody drug products has been attributed to residual enzymes (e.g., esterases) from bioprocessing steps. Robust detection of esterase activity using sensitive, non-polysorbate surrogate substrates can provide an alternate method to assess polysorbate degradation risk, if the correlation between the esterase activity and polysorbate degradation is established.

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Journal

Journal ID (iso-abbrev): Pharm Res

Title: Pharmaceutical research

Publisher: Springer Science and Business Media LLC

ISSN (Electronic): 1573-904X

ISSN (Print): 0724-8741

Publication date (Electronic): Mar 2021

Volume: 38

Issue: 3

Affiliations

[1 ] Pharmaceutical Development, Genentech Inc., 1 DNA Way, MS 562a, South San Francisco, CA, 94080, USA. chandrasekhara.adithi@gene.com.

[2 ] Pharmaceutical Development, Genentech Inc., 1 DNA Way, MS 562a, South San Francisco, CA, 94080, USA.

[3 ] Department of Chemical and Biological Engineering, University of Colorado, Boulder, 3415 Colorado Ave, Boulder, CO, 80303, USA.

[4 ] Pharmaceutical Development, AbbVie Inc., 1500 Seaport Blvd, Redwood City, CA, 94065, USA.

[5 ] Cell Culture and Bioprocess Operations, Genentech Inc., 1 DNA Way, MS 96a, South San Francisco, CA, 94080, USA. inn@gene.com.

Article

Publisher Item ID: 10.1007/s11095-021-03011-1

DOI: 10.1007/s11095-021-03011-1

PubMed ID: 33655394

SO-VID: 6e33724a-7b8c-4d8e-8995-f05d2f1cd118

History

Keywords: esterase,polysorbate degradation,enzyme assay

Data availability:

Keywords: esterase, polysorbate degradation, enzyme assay

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