February 14, 2018
11 am to 12 pm EST
BioGenes´ strategy for host cell protein (HCP) analysis
Host cell proteins (HCPs) are residual impurities from the production cell lines of biotherapeutical drugs. Even though biologicals undergo several purification steps during the manufacturing process, HCPs might still be co-purified with the drug
substance during down-stream processing. When applied to patients, these residual HCPs might elicit an unwanted immune reaction, and pose an unpredictable risk. To ensure patient safety, highly sensitive and robust methods are needed for reliable
monitoring of the broad spectrum of which HCPs comprise. So far, ELISA is the work-horse for determination of HCPs, and a widely accepted method for regulatory authorities to qualify biologicals for drug approval. During preclinical or early clinical
phases, generic “ready-to-use” HCP ELISA kits are often the first choice to measure HCP decrease because of their cost-effectiveness and easy availability. Later clinical phases, in contrast, require customized and complex HCP ELISAs
to ensure coverage of the full range of process specific HCPs. How to choose a generic kits, and when is the right time to begin with a specific assay development without time loss, are two crucial questions that have to be answered during the
manufacturing a biological. This webinar will give you insights into BioGenes’ strategy for appropriate generic kit assessment and selection, as well as recommending the best time at which to switch.
- BioGenes´ performance study: How can you find the best generic host cell protein (HCP) assay for early clinical phases?
- Generic vs specific HCP ELISA: When is the right time to switch?
- Recommendations for the development of your process-specific HCP ELISA.
- Characterization of anti-HCP-antibodies via fluorescence-based 2D Western Blot.
Dr. Nancy Urban
Marketing / Sales Manager
Diploma Biochemistry/Molecular Biology, University of Hamburg
PhD Immunology, Bernhard-Nocht-Institute Hamburg
Nancy Urban studied Biochemistry and Molecular Biology at the University of Hamburg. After finishing her Diploma Thesis at the Max Planck Institute for Marine Microbiology in Bremen, she started her PhD at the Bernhard-Nocht-Institute for Tropical
Diseases in Hamburg. In her thesis, she focused on the adaptive immune response against the tropical agent Leishmania. Afterwards, she took up a postdoc position at Imperial College London, where she worked on the new concept of chimeric antigen
receptor T cells, and their therapeutic potential in ovarian cancer. Nancy joined BioGenes in 2011 and worked as a Scientific Sales Manager for five years before recently becoming a Marketing/Sales Manager.
Dr. Marieke Mohr
Marketing / Sales Manager
Diploma Biology, University of Hohenheim, Hohenheim and Eberhard-Karls-University of Tuebingen, Tuebingen
PhD Biomedicine, University of Witten/Herdecke, Witten
Marieke Mohr received her diploma degree in Biology from the universities of Hohenheim and Tuebingen. During her PhD studies at the private University of Witten/Herdecke, she was one of the first students to take part in a biomedical PhD program comprising
of young physicians and biologists. Her research was focused on the impact of inflammatory molecules on spontaneous cell fusion events of cancer cells with stem cells, or with immune cells infiltrating the tumor environment. Due to her strong
focus on immuno-oncology, she joined the Monoclonal Antibody and Immunotherapy laboratory of Dr. Soldano Ferrone at the MGH as a postdoctoral research fellow at Harvard University in Boston. In this position, that was awarded with a fellowship
from the Dr. Werner-Jackstädt-Foundation, she investigated molecular escape strategies used by tumor cells to avoid recognition by immunotherapies. Furthermore, she worked on the development of combinatorial CAR T cell-based immunotherapies
to target solid tumors in preclinical murine models. Since 2017, she has been a Marketing/Sales Manager at BioGenes.