Immunogenicity Testing For Biosimilars
Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing costs while providing patients with…
Determining Immunogenicity for CAR-T cell Therapies
Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T cells against cancer cells. CAR-T…
Challenges for Measuring Immunogenicity of AAV-based Gene Therapies
Gene therapy is a powerful form of treatment that involves introducing genetic material into cells to replace defective genes resulting in the production of an…
Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials
The concept of using pre-existing immunogenicity as an exclusion criteria for gene therapy clinical trials is changing. BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, explores…
Turning Around a Troubled Study: A Rescue Project Success Story
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…
Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics
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…
Immunogenicity Assessment Using the Biacore™ T200 SPR System
What are the advantages of using the Biacore™ T200 SPR System for immunogenicity assessments with a tiered approach? Our experts discuss.
To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Target interference can cause false positive ADA assay results and stall out promising drugs. This could have been the case for one study involving an…
Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered
The webinar I recently hosted with my colleague Lydia Michaut explored key challenges and trends in the immunogenicity assessment of gene therapy compounds. This recap…
New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications
The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several…