Large scale demonstration of a process analytical technology application in bioprocessing: use of on-line high performance liquid chromatography for making real time pooling decisions for process chromatography

Biotechnology Progress
Anurag RathoreYuefeng Lu

Abstract

Process Analytical Technology (PAT) has been gaining a lot of momentum in the biopharmaceutical community because of the potential for continuous real time quality assurance resulting in improved operational control and compliance. In previous publications, we have demonstrated feasibility of applications involving use of high performance liquid chromatography (HPLC) and ultra performance liquid chromatography (UPLC) for real-time pooling of process chromatography column. In this article we follow a similar approach to perform lab studies and create a model for a chromatography step of a different modality (hydrophobic interaction chromatography). It is seen that the predictions of the model compare well to actual experimental data, demonstrating the usefulness of the approach across the different modes of chromatography. Also, use of online HPLC when the step is scaled up to pilot scale (a 2294 fold scale-up from a 3.4 mL column in the lab to a 7.8 L column in the pilot plant) and eventually to manufacturing scale (a 45930 fold scale-up from a 3.4 mL column in the lab to a 158 L column in the manufacturing plant) is examined. Overall, the results confirm that for the application under consideration, online-HPLC offers a feasib...Continue Reading

References

May 3, 2003·Analytical and Bioanalytical Chemistry·Roland UlberSascha Beutel
Aug 26, 2006·Biotechnology and Bioengineering·B H Junker, H Y Wang
May 4, 2007·Analytical Chemistry·Jerome WorkmanDave Veltkamp
Apr 17, 2008·Biotechnology Progress·Jean HarmsAnurag S Rathore
Jan 10, 2009·Nature Biotechnology·Anurag S Rathore, Helen Winkle

❮ Previous
Next ❯

Citations

May 19, 2010·Analytical and Bioanalytical Chemistry·A S RathoreV Ghare
Sep 4, 2016·Analytical and Bioanalytical Chemistry·Vignesh RajamanickamOliver Spadiut
Jan 25, 2011·Trends in Biotechnology·Rahul BhambureAnurag S Rathore
Apr 5, 2019·Biotechnology Journal·Nicole WalchAlois Jungbauer
Jul 8, 2017·The Cochrane Database of Systematic Reviews·Christina TikkaSilvia Ferrite
Jun 1, 2018·Analytical Chemistry·Anamika TiwariAnurag S Rathore

❮ Previous
Next ❯

Related Concepts

Related Feeds

Bioinformatics in Biomedicine

Bioinformatics in biomedicine incorporates computer science, biology, chemistry, medicine, mathematics and statistics. Discover the latest research on bioinformatics in biomedicine here.