Protect mAb stability: Control polysorbate-degrading HCPs скачать в хорошем качестве

Protect mAb stability: Control polysorbate-degrading HCPs

Degradation of polysorbate (PS) excipients is a significant risk to mAb product stability and efficacy and may be caused by host cell proteins. Host cell proteins such as phospholipase B-like 2 (PLBL2) and lipoprotein lipase (LPL) can co-elude through all standard mAb purification steps and cause project delays if they are not adequately removed – and classical impurity assays (HCP ELISA) cannot detect them individually. In this webinar, Ejvind Mørtz will present the latest research on PS-degrading HCPs, key industry developments, and regulatory updates impacting mAb drug products. The webinar includes: • New and upcoming regulations affecting HCP control, including ICH guidelines Q14 on analytical procedure development and US Pharmacopeia • General Chapter 1132.1 on Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry. • Examples of PS-degrading host cell proteins. • Client cases on polysorbate-degrading HCPs – learn how mAb developers use MS-based HCP analysis for process development and documentation for regulatory applications. Learn more at https://alphalyse.com/services/monito...