Read time: 5:30 mins
In this interview, Arno Kromminga discusses the benefits and challenges associated with current methods, and what he believes the future holds for immunogencity.
Read time: 5:30 mins
Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in Japan
In this review, the authors introduce the current situation regarding the development and immunogenicity assessment of therapeutic protein products in Japan. Then they present their view and recommendations on the ADA assay by considering its unique features.
In this month long feature, we bring you a collection of content focusing on the ‘hot topic’ of immuno-oncology.
LC-MS-based approaches are increasingly used for the quantification of proteins in biological samples. Traditionally, triple…
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?