Protocol to Assess the Biological Activity of Insulin Glargine, Insulin Lispro, and Insulin Aspart In Vitro

Mamatha Garige; Susmita Ghosh; Brian Roelofs; V. Ashutosh Rao; Carole Sourbier

doi:10.3390/mps6020033

Methods and Protocols (Mar 2023)

Protocol to Assess the Biological Activity of Insulin Glargine, Insulin Lispro, and Insulin Aspart In Vitro

Mamatha Garige,
Susmita Ghosh,
Brian Roelofs,
V. Ashutosh Rao,
Carole Sourbier

Affiliations

Mamatha Garige: Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
Susmita Ghosh: Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
Brian Roelofs: Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
V. Ashutosh Rao: Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
Carole Sourbier: Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA

DOI: https://doi.org/10.3390/mps6020033
Journal volume & issue: Vol. 6, no. 2
p. 33

Abstract

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Insulin is a hormone produced by β-cells of the pancreas and controls the amount of sugar in the blood. Since its discovery over 100 years ago, insulin has been used as a life-saving treatment for people with diabetes. Historically, the biological activity or bioidentity of insulin products has been assessed using an in vivo model. However, reduction in animal experiments is a goal for many worldwide, and there is a need to develop in vitro bioassays to reliably test the biological activity of insulin products. This article describes an in vitro cell-based method to assess the biological activity of insulin glargine, insulin aspart, and insulin lispro in a step-by-step manner.

Published in Methods and Protocols

ISSN: 2409-9279 (Online)
Publisher: MDPI AG
Country of publisher: Switzerland
LCC subjects: Science: Biology (General)
Website: https://www.mdpi.com/journal/mps

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