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 gene and cell therapies
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
Adenovirus and HCP profiling for cancer immuno-oncology therapies
(in the planning)
24 October | 16.30 CET • 7.30 PST • 10.30 EST (45 minutes) - LIVE ONLY
Residual protein analysis in lentivirus transduced CD34+ Cell therapeuticsFaucibus scelerisque eleifend nulla veniam duis
(in the planning)
29 November | 16.30 CET • 7.30 PST • 10.30 EST (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)
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.
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.