Webinars
Protect mAb stability: Control polysorbate-degrading HCPs
November 2024, by Ejvind Mortz
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 – learn how mAb developers use MS-based HCP analysis for process development and documentation for regulatory applications.
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