An analytical quality by design approach towards a simple and novel HPLC-UV method for quantification of the antifibrotic peptide N-acetyl-seryl-aspartyl-lysyl-proline

One-Step Quantification of anti-Covid-19 Antibodies via Dual Affinity Ratiometric Quenching Assays

“…Biopharmaceutical industries currently rely on analytical Protein A HPLC and BLI for monitoring the mAb titer across the production pipeline. , As characteristically off-line assays, HPLC and BLI do not allow real-time optimization of bioprocess operations, especially since multiple production batches are conducted in parallel. Additionally, these assays require expensive consumables, whichwith approximately up to 1,500 production campaigns per year needed to supply the US demand for therapeutic mAbsimpact significantly on production costs …”

“…Additionally, these assays require expensive consumables, which�with approximately up to 1,500 production campaigns per year needed to supply the US demand for therapeutic mAbs�impact significantly on production costs. 28 To assess the potential of DARQ as a cost-effective and robust alternative to HPLC and BLI for real-time bioprocess monitoring, we conducted the quantification of anti-SARS-CoV-2 mAbs in a clarified cell culture supernatant produced by Chinese hamster ovary (CHO) cells and in an aqueous buffer (i.e., PBS at pH 7.4), respectively, mimicking a bioreactor harvest and a chromatographic polish fraction. For both fluids, a preformulated mix of Rh PrL and fluorescein-labeled antigen (i.e., Fl N-CoV-2, Fl δ-RBD, and Fl ο-RBD), both at a titer of 23.2 nM, was combined with the sample containing the analyte antibody (i.e., N-mAb, δ-mAb, and ο-mAb).…”