From The Stage

Turning Around a Troubled Study: A Rescue Project Success Story

Posted by / / CRO Selection, Immunogenicity

When you have a program that has stalled or gone off schedule, it is vital to team up with a CRO laboratory that is capable of handling quick turnarounds and rescue projects. We look at an example of how BioAgilytix sprung to action to transform a troubled study.

Webinar Sneak Peek: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

Posted by / / BioAgilytix Insight, Biosimilars, Immunogenicity

On January 23rd I’ll be hosting a webinar with Dr. Dominque Gouty that will summarize key insights from the recently published paper by the American Association of Pharmaceutical Scientists (AAPS) entitled “Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs”. I had the privilege to contribute as an author on this pivotal paper, which lays out a consensus recommendation for use of a one-assay approach to develop and validate ADA assays supporting biosimilar drug development programs. It has taken years of industry discussion and collaboration…

Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics

Posted by / / Bioanalytical Platforms, Immunogenicity

The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less prevalent than IgG antibodies, a very sensitive detection method is required. We discuss why the ImmunoCAP platform provides an ideal system to analyze IgE-mediated drug hypersensitivities.