Live webinar

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

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 of these presentations is on analytical methods, e.g., LC-MS and ELISA, for characterizing host cell proteins (HCPs), residual proteins, viral vector proteins, and other proteins present in biologics and advanced therapies.

The invited speakers are all experienced scientists within their respective fields and companies’ products. We highly appreciate their kindness to share their experience and work in progress. Upcoming and past events are listed below.

  • NEXT EVENT:

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

    Margarita Sabater, Senior CMC Specialist Genmab, Denmark
    17 April​​​ | 16.30 CEST • 10.30am EST • 8.30am PST

    In this presentation, Genmab presents a second element of their holistic HCP Control Strategy. This part goes into detail on how to use LC-MS to assess process changes, demonstrate HCP clearance, and document process consistency.

    Furthermore, Margarita will share the experiences and knowledge from the feedback from the authorities from licensing applications in Europe, Japan, and the US markets.

  • PAST EVENTS:

    mAb 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

  • Margarita Sabater, Senior CMC Specialist Genmab, Denmark

    Margarita is a Senior Subject Matter Expert (SME) and Analytical Lead in the Late Stage Manufacturing Development group at Genmab. Her group is responsible for developing and validating analytical methods, including potency assays and host cell protein impurity assays, in support of pre-clinical and clinical development of monoclonal antibody programs. Previously, she led the quality control bioassay and impurities group at Novo Nordisk and has wide expertise in host cell impurity analysis. She received her master's (MSc) in chemical engineering from the Autonomous University of Barcelona, Spain.

  • Søren Skov Jensen, Senior CMC Specialist Genmab, Denmark

    Søren is a Senior Subject Matter Expert (SME) in Extended Characterization in the Late Stage Manufacturing Development group, CMC, at Genmab. His group is responsible for extended characterization supporting pre-clinical and clinical development of monoclonal antibody programs. He has a mass spectrometry and proteomics background from the University of Southern Denmark.

  • Bryant McLaughlin, PhD, CMC Executive, USA

    For 15 years, Bryant has held CMC executive positions in biotech companies including Genentech, Nektar Therapeutics, and 9 Meters Biopharma, developing mAbs and mAb-like products. His extensive experience includes biologics process and analytical development (including residual host cell protein assay validation), process characterization and validation, and global CMC regulatory writing and strategy.

  • Robert Hooper, PhD Senior Research Scientist, Rockland Immunochemicals Inc, USA

    Robert has solid experience from both academia and industry, with a strong publication record. Since he joined Rockland in 2019, his primary role has been the development of immunoassays for novel targets, in some instances starting with the validation of newly generated antibodies and taking these through to a finished assay kit for the market.

  • Yiling Bi, Senior Scientist, Sangamo Therapeutics, USA

    Yiling Bi is a senior scientist in analytical development department at Sangamo Therapeutics. Yiling is responsible for characterization of AAV-based gene therapies using LC-MS, as well as working with CRO/CTLs and vendors for routine testing and new technology evaluations.

  • Albert Molina Gil, Process Development Scientist, Orchard Therapeutics

    Albert holds an industry-partnered PhD in Gene Therapy from University College London and GlaxoSmithKline. Following his PhD, he led the development of a stable cell line platform for gamma-retroviral vector production. In his current position, he develops and optimizes platform technologies enabling the generation and characterization of stable cell lines and lentiviral vector production processes for treating genetic diseases.

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