CE-SDS method development, validation and best practice - An overview

Cari E Sänger-van de Griend

doi:10.1002/elps.201900094

CE-SDS method development, validation and best practice - An overview

Cari E Sänger-van de Griend

Research output: Contribution to Journal › Review article › Academic › peer-review

Abstract

CE-SDS has been implemented in the biopharmaceutical industry and is being used for the characterization of therapeutic proteins in most Biological License Applications currently submitted. An overview is presented on the separation mechanism, methodology and good working practices / best practices. The CE-SDS platform method development and validation are discussed and typical scientifically and regulatory issues and troubleshooting situations are highlighted. This article is protected by copyright. All rights reserved.

Original language	English
Pages (from-to)	2361-2374
Number of pages	14
Journal	Electrophoresis
Volume	40
Issue number	18-19
Early online date	29 May 2019
DOIs	https://doi.org/10.1002/elps.201900094
Publication status	Published - Sept 2019

Bibliographical note

Special Issue: Celebrating Professor Ziad El Rassi's 70th Birthday and His 25 Years of Dedication to Electrophoresis.

This article is protected by copyright. All rights reserved.

Keywords

Best practice
CE-SDS
Method development
Method validation
Platform methodology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/elps.201900094

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KW - CE-SDS

KW - Method development

KW - Method validation

KW - Platform methodology

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CE-SDS method development, validation and best practice - An overview

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

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