Mid-UV Protein Absorption Spectra and Partial Least Squares Regression as Screening and PAT Tool-Reference-Cited by-同舟云学术

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Mid-UV Protein Absorption Spectra and Partial Least Squares Regression as Screening and PAT Tool

Published:2017-02-03 Issue: Volume: Page:501-536
ISSN:
Container-title:Preparative Chromatography for Separation of Proteins
language:
Short-container-title:

Author:

Hansen Sigrid¹,Brestrich Nina²,Staby Arne³,Hubbuch Jürgen²

Affiliation:

1. Protein Purification Development, Novo Nordisk A/S; Gentofte Denmark

2. Institute of Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering; Karlsruhe Institute for Technology; Karlsruhe Germany

3. CMC Project Planning & Management, Novo Nordisk A/S; Bagsvaerd Denmark

Publisher

John Wiley & Sons, Inc.

Reference48 articles.

1. ICH 2008 Pharmaceutical development

2. FDA 2004 Guidance for Industry. PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance

3. High throughput screening of chromatographic phases for rapid process development;Bensch;Chem Eng Technol,2005

4. High-throughput process development for recombinant protein purification;Rege;Biotechnol Bioeng,2006

5. Case study and application of process analytical technology (PAT) towards bioprocessing: Use of tryptophan fluorescence as at-line tool for making pooling decisions for process chromatography;Rathore;Biotechnol Prog,2009

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1. Robust method for chromatogram shape analysis to improve early detection of performance drifts and adverse changes in process parameters during purification column operations;Biotechnology Journal;2023-12-11

2. Continuous integrated manufacturing for biopharmaceuticals: A new paradigm or an empty promise?;Biotechnology and Bioengineering;2022-09-28

3. Challenges in process control for continuous processing for production of monoclonal antibody products;Current Opinion in Chemical Engineering;2021-03

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