Minimising allergic reactions to intravenous immunotherapies with new biosafety testing

Drug development proceeds along a regulated pathway from innovation and research to preclinical and clinical trials to review by national authorities. Many drugs do not make it through clinical trials due to unpredicted adverse side effects in people. Others make it through, despite the side effects, when these are deemed of low enough risk or incidence. For many therapies administered intravenously, infusion reactions (IRs) are common, particularly among immunotherapeutics. Even though these can be severe and even life-threatening, assaying for allergic IRs before a drug gets to clinical phases is challenging because relevant biomarkers or animal models are scarce. EU funding of the Biosafety project is building capacity at Hungary’s Semmelweis University with the goal of addressing this problem to enhance the safety of immunotherapeutics for patients who need them.


The objective of this Twinning project is to significantly strengthen the research in SEMMELWEIS EGYETEM in the smart specialization area of Hungary “bio-medicine, medical technologies, and biotechnologies” with application to immune- and biosafety assays through building an up-rising connections with internationally leading research institutions, which represent centers of excellence in the design, testing and clinical applications of a wide class of Immunotherapeutics, with focus on infusion reactions (IRs). IRs are complex, immune-mediated side effects, also known as hypersensitivity reactions (HSRs), that can occur upon intravenous infusion of pharmaceuticals, leading to severe and sometimes life-threatening conditions in patients. Regulatory guidance on the assessment of infusion hypersensitivity has been published recently for the case of generic liposome production. Hemocompatibility (blood safety) testing for medical devices is requested by EMA and FDA since many years. However, regarding the potential of new pharmaceuticals causing allergies remains a significant challenge for the industry during nonclinical development as no established safety biomarker nor meaningful, validated animal models are available up to date and this will be addressed in the BIOSAFETY project.