Summary
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.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/952520 |
| Start date: | 01-09-2020 |
| End date: | 31-08-2023 |
| Total budget - Public funding: | 900 000,00 Euro - 900 000,00 Euro |
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Original description
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.Status
SIGNEDCall topic
WIDESPREAD-05-2020Update Date
17-05-2024
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