Is Your Biotherapeutic Immunomodulatory? How to Use Immunoassays to Get the Right Answer

Biotherapeutics are a class of large medicinal products that are being increasingly used for various medical applications including vaccination, therapeutic drug delivery systems and the treatment of human diseases. Biotherapeutics offer the advantages of increased specificity and reduced toxicity compared to small molecules. However, they can inappropriately activate the immune system. This potential biotherapeutics-mediated immunogenicity must be assessed as early as possible during drug development since it can be the cause of serious events such as autoimmunity, inflammation, anti-drug antibodies (ADAs) production, hypersensitivity reactions (allergenicity) or cytokine storm syndrome. Moreover, since biotherapeutics are produced using biological means, the development of biosimilars must include comparative immunogenicity and biological assay testings.