Live Webinar Series

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

About The Webinar

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 HCP assay validation and GMP release testing for complex samples

    Thomas Kofoed, Alphalyse, Denmark

    30 May | 16.30 CEST • 7.30am PDT • 10.30am EDT (45 minutes)

  • Analysis of host cell proteins in complex bacteriophage products

    (in the planning)
    5 September​​​ | 16.30 CEST • 7.30 PDT • 10.30 EDT (45 minutes) - LIVE ONLY

  • PAST EVENTS:

    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 AAV-based Gene Therapy Product​​​​​​​

    Yiling Bi, Sangamo Therapeutics, USA
    28 February | 19.00 CET • 10am PST • 1pm EST (45 minutes) - LIVE ONLY

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

    Ejvind Mortz, Alphalyse, Denmark
    17 April | 16.30 CEST • 7.30am PDT • 10.30am EDT (45 minutes)

  • Thomas Kofoed, PhD, Co-Founder & CEO, Alphalyse, Denmark

    Thomas holds a PhD in Organic Chemistry and a BSc in Business Administration. He has 20+ years of management experience in the biotech industry and has developed protein analyses and mass spectrometry methods in the research & development of protein biologics; vaccines, monoclonal antibodies, therapeutic proteins, and cell and gene therapies.

  • 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.

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