Webinar
Managing Sensitivity in Neutralizing Antibody Assays: When Wide Dynamic Range Makes Yes Mean No and No Mean Yes
As part of the 2020 Land O’ Lakes Virtual Conference, BioAgilytix’s David Rusnak, Director, Bioanalytical Operations, gave a presentation exploring how sensitivity in neutralizing antibody…
ELISpot Method Development and Validation for Gene Therapies: Building on 2019 WRIB Recommendations, Practical Case Studies, Lessons Learnt and Evolving Trends
Unlike ADA- or NAb-detecting protocols, there is no regulatory guidance currently for how to develop and validate ELISpot methods. The recommendations in the 2019 WRIB…
On-Demand Webinar: Translation of a Diagnostic Virus Neutralization Method to a Quantitative Relative Potency Assay for an Anti-Viral Antibody
Many anti-viral biotherapeutics operate through neutralization of the virus or kill infected cells and employ in vivo testing to measure potency, function and efficacy. In…
On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars
The demonstration of similar immunogenicity is a critical requirement for the demonstration of similarity between a biosimilar candidate and the respective reference product. While recent…
On-Demand Webinar: Exploratory Biomarker Testing – to Qualify or Validate the Assay?
There is much confusion in the world of biomarker testing when it comes to ‘assay qualification’ vs ‘assay validation’ because the terms are not strictly…
Webinar Recording: Immunogenicity assessment of gene therapy compounds: discussion on current and future concepts
After a series of setbacks in the nineties, several gene therapies have now been approved by health agencies worldwide. As a consequence, the number of these…
Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses
Ultimately, all biological drugs are immunogenic. Over the last several years, methods for the detection of drug-induced antibodies have become more sensitive, which means that…
Webinar on Demand: Challenges of Single and Multiplex Biomarker Validation on ‘Planet Earth’ Versus ‘Planet Biomarkertopia’
This presentation will focus on case studies through the eyes of a biomarker scientist working before and after being transported from ‘planet Earth’ to ‘planet…
Webinar on Demand: Recent Aspects and Challenges in the Assessment of Immunogenicity
The assessment of immunogenicity of biological protein drugs is a key component in drug development. A basic knowledge in immunology is a prerequisite for understanding…