Webinar

Experimental Comparison of 3 MS Quantitation Methods in USP <1132.1>

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.

  • Experimental Demonstration and Comparison of Three MS Quantitation Methods as Outlined in USP <1132.1>

    Victor Chrone, MSc Bioinformatics Scientist, Alphalyse, Denmark
    REPLAY AVAILABLE



    The demand for orthogonal methods providing detailed information on individual HCPs has increased.

    This has culminated in the establishment of the new USP-NF Chapter ⟨1132.1⟩ Residual Host Cell Protein Measurement in Biopharmaceuticals by Liquid Chromatography-Mass Spectrometry, which outlines 3 methods for quantifying HCPs using mass spectrometry (MS).


    ​​​​​​​HCP analysis by MS is complex, expensive, and necessitates skilled professionals for setup and operation, and its implementation can pose significant challenges. This raises the question: how can these methods be integrated into practical testing, and what are the advantages, disadvantages, and potential pitfalls of each method?


    Join this webinar to learn the following:


    • Comparative Analysis: A side-by-side comparison of the three LC-MS methods, demonstrating how each approach works and what results they yield.


    • Strengths and Weaknesses: Which method is best suited for different stages in biopharmaceutical development, e.g., early development, drug substance release, process monitoring, or impurity clearance studies?


    • Practical Implementation: Overview of method requirements, including equipment, preparation steps, and common pitfalls.

    ​​​​​​​

  • 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

    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

  • Presenter

  • Victor Chrone, MSc, Bioinformatics Scientist, Alphalyse, Denmark

    Presenter

  • , ,