Issue 20 of Bioanalysis volume 9 is now available, including an editorial surrounding the factors which may impact PK measurements of antibody therapeutics alongside the latest methodologies, research articles and discussions of current bioanalytical challenges. Find out more about the issue here, or on the Bioanalysis webpage.
In this ‘Ask the Experts’ feature we will be discussing what is required to gain approval for a biosimilar.
In this ‘Ask the Experts’ feature we will be discussing the use of biosimilars with a number of leading experts across the field. The series will explore the role of biosimilars, address the benefits and challenges of creating them and how they have gained momentum within the pharmaceutical industry.
8. What are the challenges for demonstrating that immunogenicity risks for the biosimilar are less or equivalent to the innovator material?
In this feature, our experts discuss what the challenges are for demonstrating that immunogenicity risks for the biosimilar are less or equivalent to the innovator material.
Weiping Shao discusses biomarkers, immunogenicity and the work he contributes to at Regeneron Pharmaceuticals (NY,USA).
Available to view on demand
We want to assess and mitigate risk from pre-existing antibodies early within clinical development. Will pre-existing antibodies impact our clinical trial?
In this interview Mohsen Rajabi (FDA) discusses the process of FDA approval, why immunogenicity assays are so important and what he believes the future may hold for immunogenicity testing.
This article describes the nature of the immune response to protein therapeutics, their clinical relevance, methodology for measuring it and approaches to interpreting the data.
In this series we will be discovering what immunogenicity is, why it is important and how is it regulated and standardized.
All biological protein drugs are immunogenic, which may lead to severe clinical consequences. This makes knowledge of the scientific and regulatory aspects of immunogenicity a must for every drug manufacturer.