Development of a Monocyte Activation Test as an Alternative to the Rabbit Pyrogen Test for Mono- and Multi-Component Shigella GMMA-Based Vaccines
| العنوان: | Development of a Monocyte Activation Test as an Alternative to the Rabbit Pyrogen Test for Mono- and Multi-Component Shigella GMMA-Based Vaccines |
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| المؤلفون: | Omar Rossi, Danielle Carson, Elena Palmieri, Caroline Vipond, Ida Karin Nordgren, Francesca Micoli, Sjoerd Rijpkema, Francesca Necchi, Sophie Myhill |
| المصدر: | Microorganisms, Vol 9, Iss 1375, p 1375 (2021) Microorganisms Volume 9 Issue 7 |
| بيانات النشر: | MDPI AG, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | 0301 basic medicine, Microbiology (medical), Drug, QH301-705.5, media_common.quotation_subject, reactogenicity, chemical and pharmacologic phenomena, medicine.disease_cause, Microbiology, Article, pyrogenicity, 03 medical and health sciences, 0302 clinical medicine, Antigen, Virology, medicine, Shigella, monocyte activation test (MAT), 030212 general & internal medicine, Biology (General), Safety testing, media_common, Activation test, Chemistry, Monocyte, outer membrane vesicle (OMV), hemic and immune systems, generalised modules for membrane antigens (GMMA), 030104 developmental biology, medicine.anatomical_structure, Bacterial endotoxin, lipids (amino acids, peptides, and proteins), Bacterial outer membrane |
| الوصف: | Generalised modules for membrane antigens (GMMA)-based vaccines comprise the outer membrane from genetically modified Gram-negative bacteria containing membrane proteins, phospholipids and lipopolysaccharides. Some lipoproteins and lipopolysaccharides are pyrogens thus, GMMA-based vaccines are intrinsically pyrogenic. It is important to control the pyrogenic content of biological medicines, including vaccines, to prevent adverse reactions such as febrile responses. The rabbit pyrogen test (RPT) and bacterial endotoxin test (BET) are the most commonly employed safety assays used to detect pyrogens. However, both tests are tailored for detecting pyrogenic contaminants and have considerable limitations when measuring the pyrogen content of inherently pyrogenic products. We report the adaptation of the monocyte activation test (MAT) as an alternative to the RPT for monitoring the pyrogenicity of Shigella GMMA-based vaccines. The European Pharmacopoeia endorses three MAT methods (A–C). Of these, method C, the reference lot comparison test, was identified as the most suitable. This method was evaluated with different reference materials to ensure parallelism and consistency for a mono- and multi-component Shigella GMMA vaccine. We demonstrate the drug substance as a promising reference material for safety testing of the matched drug product. Our results support the implementation of MAT as an alternative to the RPT and use of the defined parameters can be extended to GMMA-based vaccines currently in development, aiding vaccine batch release. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2076-2607 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f4b5cb066d2aec96a9c2c8b9fd300184Test https://www.mdpi.com/2076-2607/9/7/1375Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....f4b5cb066d2aec96a9c2c8b9fd300184 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20762607 |
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