Live Webinar Series

Product-Specific HCP Profiling of
​​​​​​​Advanced Therapies and Vaccines​​​​​​​

About the Webinar Series

Developers of advanced therapies find it challenging to control production processes, including characterization of the Host Cell Proteins (HCPs) and other proteins/enzymes added during the upstream/downstream process. The products are complex, and manufacturing processes are constantly improving. Also, the analytical methods are not as mature as for traditional biologics, and they must be customized since the upstream/downstream processes differ widely between products.

In these live broadcasts, leading cell & gene therapy, phage, and vaccine developers present approaches to the CMC challenges. The focus is analytical methods for characterizing HCPs, residual proteins, viral vector proteins, and other proteins in their complex products.

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

    Albert Molina Gil, Orchard Therapeutics, UK
    17 January | 16.30 CET • 7.30 PST • 10.30 EST (45 minutes) - LIVE ONLY

  • Challenges and Considerations in the Host Cell Protein Analysis for Gene Therapy Products​​​​​​​

    Yiling Bi, Sangamo Therapeutics, USA
    28 February | 19.00 CET • 9am PST • 12noon EST (45 minutes) - LIVE ONLY

  • HCP assays for pandemic vaccines: A case on adenovirus COVID-19 vaccines

    Ejvind Mortz, Alphalyse, Denmark
    28 March | 16.30 CET • 7.30 PST • 10.30 EST (45 minutes)

  • LC-MS HCP assay validation and GMP release testing for gene and cell therapies

    Thomas Kofoed, Alphalyse, Denmark

    2 May | 16.30 CET • 7.30 PST • 10.30 EST (45 minutes) - LIVE ONLY

  • Residual protein analysis in lentivirus transduced CD34+ Cell therapeutics

    (in the planning)
    ​​​​​​​20 June | 16.30 CET • 7.30 PST • 10.30 EST (45 minutes) LIVE ONLY

  • Analysis of host cell proteins in complex bacteriophage products

    (in the planning
    1​​​​​​6 September | 16.30 CET • 7.30 PST • 10.30 EST (45 minutes) LIVE ONLY

  • Adenovirus and HCP profiling for cancer immuno-oncology therapies

    (in the planning
    1​​​​​​​7 October | 16.30 CET • 7.30 PST • 10.30 EST (45 minutes) LIVE ONLY

  • Yiling Bi , Scientist III, Sangamo Therapeutics, USA

    Yiling Bi is a 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.

  • Ejvind Mørtz, PhD, Co-Founder & COO, 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.

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