Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis

Validation of Protein A chromatography: orthogonal method with size exclusion chromatography validation for mAb titer analysis

After reviewing the reference product specifications, found that they include the SEC HPLC result but do not specify Protein A chromatography as a test. Although there is no record of reference product specifications, alternative methods are necessary, particularly for routine analysis of biotechnol...

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Bibliographic Details
Main Authors: Sahinkaya Elif, Ozkan Aylin, Ozdemir Nilay, Aslan Merve Elif, Bicak Dilan, Cakir Nilufer, Oncel Hatice, Yetimoglu Ece Kok
Format: Article
Language:English
Published: De Gruyter 2025-05-01
Series:Türk Biyokimya Dergisi
Subjects:
monoclonal antibody
bioanalytical method development
bioanalytical method validation
biotechnology
chromatography
ich m10 guideline
Online Access:https://doi.org/10.1515/tjb-2024-0186
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Summary:After reviewing the reference product specifications, found that they include the SEC HPLC result but do not specify Protein A chromatography as a test. Although there is no record of reference product specifications, alternative methods are necessary, particularly for routine analysis of biotechnological products.
ISSN:1303-829X

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