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Expert perspectives focused on the latest bioanalytical topic & trends

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 broader access to critical medicines. The recent boom in the biosimilars market seen following a wave of blockbuster molecules coming off patent between 2015 and 2020 demonstrates the powerful allure of the potential of biosimilars1. During this time, the market rapidly expanded at a compound

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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 cells are generated by engineering T cells to express a chimeric antigen receptor, which is typically an antibody directed against a target on the cancer cell, fused with TCR signaling components. Several CAR-T cell products have been approved for treatment of hematological cancers, and there

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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 essential protein. If a defective gene causes a required protein to be faulty or absent, gene therapy may be able to restore the protein’s function by introducing a “healthy” copy of the gene. Since gene therapy products work by introducing genetic material into the cell,

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BioAgilytix AAPS white paper webinar blog

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

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

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Platform Spotlight: ImmunoCAP

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 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.

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