How To Select And Validate A Generic CHO HCP ELISA For Process Development

Off-the-shelf generic and commercial CHO HCP ELISAs are commonly used to quantitate HCP in early process development. However, it’s challenging to find and choose a generic ELISA suited to a process. Here we share a case study on selection criteria and validation of a generic ELISA for process development.

Learning objectives:

Gain access to practical guidance and an intuitive understanding of how to establish a generic CHO HCP ELISA for your process development. Learn how to compare generic ELISA kits in terms of specificity, sensitivity, reproducibility, robustness, coverage, and process compatibility.

Speaker:

Mohamed Shaker, Bachelor’s degree in Chemistry and Biology, Lead Scientist, Analytical Development, Cytiva

Mohamed Shaker is a lead analytical development scientist for the Fast Trak™ team at Cytiva and is based in Marlborough, MA, USA. Mohamed has 13 years of biopharma experience spanning upstream (including perfusion and transfections), downstream chromatography, and analytical method qualification and validation. He is experienced in the characterization of enzyme replacement therapy, biosimilars, mAbs and biopharmaceutical protein by performing HPLC, UPLC, glycan mapping, Poros, HIC, CEX, SDS-PAGE, Western blots, IEF, ELISA and Biacore™ analyses. He has also developed various HPLC methods for multi-molecule product characterization.