Application of Raman spectroscopy in monoclonal antibody producing continuous systems for downstream process intensification

Abstract

Monoclonal antibodies (mAbs) are biopharmaceuticals produced by mammalian cell lines in bioreactors at a variety of scales. Cell engineering, media optimization, process monitoring, and control strategies for in vitro production have become crucial subjects to meet increasing demand for these high value pharmaceuticals. Raman Spectroscopy has gained great attention in the pharmaceutical industry for process monitoring and control to maintain quality assurance. For the first time, this article demonstrated the possibility of subclass independent quantitative mAb prediction by Raman spectroscopy in real time. The developed model estimated the concentrations of different mAb isotypes with average prediction errors of 0.2 (g/L) over the course of cell culture. In situ Raman spectroscopy combined with chemometric methods showed to be a useful predictive tool for monitoring of real time mAb concentrations in a permeate stream without sample removal. Raman spectroscopy can, therefore, be considered as a reliable process analytical technology tool for process monitor, control, and intensification of downstream continuous manufacturing. The presented results provide useful information for pharmaceutical industries to choose the most appropriate spectroscopic technology for their continuous processes.

Synthesis of gold nanoparticles@reduced porous graphene-modified ITO electrode for spectroelectrochemical detection of SARS-CoV-2 spike protein

“…C—N), 1190 cm −1 (tryptophan, phenylalanine, str. C—N and bending N—H of Amide III), 1318 cm −1 (α-helix, Amide III), and 1448 cm −1 (Amide II/N—H bending, C—N stretch, bending CH 2 of proteins) [34] , [35] , [36] , [37] , [38] , [39] .

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Electrochemical Microbiosensor for Detecting COVID-19 in a Patient Sample Based on Gold Microcuboids Pattern

“…C–N in protein, phenylalanine), 1189 cm −1 (tryptophan, phenylalanine, str. C–N and bending N–H of Amide III), 1318 cm −1 (α-helix, Amide III), and 1444 cm −1 (Amide II/N–H bending, C–N stretch, bending CH 2 of proteins) [ 23 – 28 ].

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Flow virometry for process monitoring of live virus vaccines-lessons learned from ERVEBO

“…This is presumably because these tools are fairly new and significant characterization work still remains to be done to understand or establish their full potential. Unlike other more well-established PAT like Raman probes widely used for bio-process monitoring 29 – 31 , applications of flow cytometry have been limited to clinical use. Arguably, the long standing history of routine utilization of flow cytometers in rigorous clinical settings 32 to identify and monitor disease and respond to treatment provides evidence of robustness of these platforms.…”