Model based robustness analysis of an ion-exchange chromatography step-Reference-Cited by-同舟云学术

Model based robustness analysis of an ion-exchange chromatography step

Published:2007-01 Issue:1-2 Volume:1138 Page:109-119
ISSN:0021-9673
Container-title:Journal of Chromatography A
language:en
Short-container-title:Journal of Chromatography A

Author:

Jakobsson Niklas,Degerman Marcus,Stenborg Emelie,Nilsson Bernt

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference18 articles.

1. A systematic approach to the validation of monoclonal antibody manufacturing processes

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3. F.D.A. U.S Department of Health and Human Services, Guidence for Industry PAT—A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, 2004.

4. Methodologies for model calibration to assist the design of a preparative ion-exchange step for antibody purification

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