Live Webinar

US Pharmacopeia:
Initiatives for enhancing the quality and consistency
​​​​​​​of MS-based HCP analysis

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:

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

    Derrick Zhang, US Pharmacopeia, USA
    18 September 2024 | 16.30 CEST | 10.30am EDT | 7.30am PDT


    This presentation will delve into the USP's initiatives to enhance the quality and consistency of MS-based HCP analysis.

    Key developments include:

    • The introduction of a new general chapter, <1132.1> 'Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry.'
    • Documentary and physical standards for MS HCP analysis


    This chapter, currently under review by the USP Expert Panel following public comments, outlines best practices for HCP identification and quantification by LC-MS/MS.

    The USP's strategy for developing and characterizing physical standards, including intact protein and peptide standards for high-risk and abundant HCPs, will be discussed in this presentation.


    Highlights include the release of the first Analytical Reference Material;

    • Purified Recombinant CHO Phospholipase B-like 2 protein (PLBL2), and
    • The upcoming first six SIL Peptides for Clusterin and Lipoprotein Lipase


    Additionally, the presentation will cover a USP internal study on the quantification of Clusterin and Lipoprotein Lipase in monoclonal antibody (mAb) samples from CHO cells using LC-MRM, employing USP SIL peptides. This study aims to validate the effectiveness of USP HCP peptides for specific HCP quantification in line with USP General Chapter <1132.1>, ultimately enhancing the accuracy and reliability of HCP measurement in biopharmaceutical manufacturing.
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  • PAST EVENTS:

    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

  • Derrick Zhang, Senior Scientist, US Pharmacopeia, USA

    Derrick Zhang is a Senior Scientist II at US Pharmacopeia, leading the development of reference standards and analytical reference material for biologics. In previous roles at Adaptive Phage Therapeutics, he oversaw the analytical development and qualification of potency and characterization assays, including LC/MS and ELISA for Host Cell Protein analysis for DS release. At United Therapeutics Corporation, he managed assay development for DS characterization, including validation of process-specific HCP-ELISA for GMP release testing.

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

    Webinar Host

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