Live Webinar

Protect your mAb stability:
​​​​​​​Control polysorbate-degrading host cell proteins

About the event series

In these live broadcasts, we invite leading developers of new biologics, vaccines, and advanced therapies to share their approaches to CMC strategy, analytical methods, regulatory documentation, and experience with project challenges. The focus is analytical methods for characterizing host cell proteins (HCPs), residual proteins, viral vector proteins, and other proteins in biologics and advanced therapies. The speakers are experienced scientists within their respective fields and products. Find coming and past events below.

  • NEXT EVENT:

    Protect your mAb stability: Control polysorbate-degrading host cell proteins

    Ejvind Mortz, Alphalyse, Denmark
    26 November 2024 | 16.30 CET | 10.30am EST | 7.30am PST


    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 sufficiently 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 will include:

    • New and upcoming regulations affecting HCP control, including ICH guidelines Q14 on analytical procedure development and USP General Chapter <1132.1> on HCP measurement 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

  • PAST EVENTS:

    US Pharmacopeia <1132.1> and Standards to Support Mass Spectrometry-Based Host Cell Protein Analysis

    Derrick Zhang, US Pharmacopeia, USA
    18 September 2024 (45 minutes)

  • Ensure process efficiency and consistency using data from 500+ projects of MS-based HCP analysis

    Victor Chrone, Bioinformatics Scientist, Alphalyse
    2 July 2024 (45 minutes)

  • Genmab HCP Control Strategy – Part II:
    ​​​​​​​Experiences from an “off-ELISA” road

    Margarita Sabater, Senior CMC Specialist Genmab, Denmark

    17 April 2024 (45 minutes)

  • Genmab HCP Control Strategy - Part I: 
    ​​​​​​​Experiences from an “off-gel” road

    Søren Skov Jensen, Senior CMC Specialist Genmab, Denmark
    5 March 2024 (45 minutes)

  • Exclusive live Q&A session with a CMC expert

    Bryant McLaughlin, PhD, CMC Executive, USA​​​​​​​
    7 February 2024 (30 minutes)

  • Qualification of a generic CHO HCP assay by orthogonal methods and recommendations for managing critical reagent supply for the validated HCP-ELISA​​​​​​​

    Robert Hooper, Senior Research Scientist, Rockland Immunochemicals Inc, USA
    6 September 2023 (45 minutes) - LIVE ONLY​​​​​​​

  • Challenges and Considerations in the Host Cell Protein Analysis for AAV-based Gene Therapy Product​​​​​​​

    Yiling Bi, Sangamo Therapeutics, USA
    28 February 2023 (45 minutes) - LIVE ONLY

  • ​​​​​​​LC-MS-based protein profiling of lentiviral vector products for CMC development

    Albert Molina Gil, Orchard Therapeutics, UK
    17 January 2023 (45 minutes) - LIVE ONLY

  • Ejvind Mortz, COO and Co-founder Alphalyse, Denmark

    Ejvind holds a PhD from the University of Southern Denmark in Protein Chemistry & Molecular Biology. He has more than 20 years of experience developing protein analyses and mass spectrometry methods in the research & development of protein biologics; vaccines, monoclonal antibodies, therapeutic proteins, and cell and gene therapies.

  • Martin Rask Johansen, MSc, Client Relations Manager Alphalyse, Denmark

    Webinar Host

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