Use of HPLC as an Enabler of Process Analytical Technology in Process Chromatography

Analytical Chemistry
Anamika TiwariAnurag S Rathore

Abstract

Online monitoring of product quality attributes using high resolution analytical tools is a prerequisite for implementation of process analytical technology (PAT) and thereby ensuring product quality and consistency. Online high-performance liquid chromatography (HPLC) has been established for real time monitoring of product quality attributes. However, requirement of liquid handling system capable of online sampling and fractionation and interfacing it with preparative scale chromatography appends to the cost and complexity of the design module of commercially available online HPLC. This paper proposes a cost-effective approach for using a traditional offline HPLC for online analysis using a 2 way/6 port valve to facilitate simultaneous automated sampling of product stream eluting from a process column and fractionation. No sample dilution is required in the proposed approach. The versatility of the proposed online configuration has been verified by demonstrating its use for two of the most common separations required during production of monoclonal antibody therapeutics: separation of aggregates and separation of charge variants. Process modeling has been performed to allow interpolation of HPLC data and facilitate pooling to...Continue Reading

References

Jan 13, 2006·Cancer Metastasis Reviews·Wendy C WeinbergChana Fuchs
Apr 2, 2011·The Journal of Biological Chemistry·Marisa K JoubertLinda O Narhi
Aug 6, 2016·Analytical and Bioanalytical Chemistry·Karen A Esmonde-WhiteIan R Lewis

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Citations

Sep 19, 2020·Biotechnology and Bioengineering·Dhanuka P WasalathanthriZheng Jian Li
Jan 11, 2020·Frontiers in Bioengineering and Biotechnology·Nagesh K Tripathi, Ambuj Shrivastava
Jan 15, 2021·Journal of Chromatography. a·Dong-Qiang LinShan-Jing Yao
Apr 13, 2021·MAbs·Ohnmar Khanal, Abraham M Lenhoff
Feb 7, 2021·Biotechnology and Bioengineering·Garima ThakurAnurag S Rathore
Nov 9, 2018·Analytical Chemistry·Valentina D'AtriDavy Guillarme
Nov 16, 2021·Biotechnology and Bioengineering·Christopher GillespieNadine Hazelwood

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