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

Research output: Contribution to JournalReview articleAcademicpeer-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 languageEnglish
JournalElectrophoresis
DOIs
Publication statusE-pub ahead of print - 29 May 2019

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Licensure
Practice Guidelines
Industry
Proteins
Therapeutics

Bibliographical note

This article is protected by copyright. All rights reserved.

Cite this

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title = "CE-SDS method development, validation and best practice - an overview",
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.",
author = "{S{\"a}nger-van de Griend}, {Cari E}",
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year = "2019",
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issn = "0173-0835",
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CE-SDS method development, validation and best practice - an overview. / Sänger-van de Griend, Cari E.

In: Electrophoresis, 29.05.2019.

Research output: Contribution to JournalReview articleAcademicpeer-review

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AB - 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.

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