1. Development of Leptospira in vitro potency assays: EU/industry experience and perspectives.
- Author
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Klaasen HL, van der Veen M, Molkenboer MJ, and Bruderer U
- Subjects
- Animals, Antibodies, Bacterial blood, Antibodies, Bacterial chemistry, Antibodies, Bacterial immunology, Antibodies, Monoclonal chemistry, Antibodies, Monoclonal immunology, Cricetinae, Dogs, Enzyme-Linked Immunosorbent Assay methods, Enzyme-Linked Immunosorbent Assay standards, European Union, Humans, Bacterial Vaccines immunology, Bacterial Vaccines pharmacology, Dog Diseases blood, Dog Diseases immunology, Dog Diseases prevention & control, Leptospira interrogans serovar icterohaemorrhagiae immunology, Leptospirosis blood, Leptospirosis immunology, Leptospirosis prevention & control, Leptospirosis veterinary, Vaccine Potency
- Abstract
Nobivac® Lepto (MSD Animal Health) is a non-adjuvanted canine leptospirosis vaccine containing inactivated whole cells of Leptospira interrogans serogroup Canicola serovar Portlandvere and L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni. The current standard in vivo potency test is a hamster challenge test associated with major drawbacks such as animal suffering and poor reproducibility. Here, the quantification of antigenic mass by ELISA as a new in vitro potency test is described, supporting the 3Rs concept (replacement, reduction, and refinement of animal tests) and in accordance with European Pharmacopoeia Monograph 0447 (Canine Leptospirosis Vaccine [Inactivated]). The two corresponding sandwich ELISAs are based on monoclonal antibodies specific for immunodominant leptospiral lipopolysaccharide epitopes. Protection in passive immunization experiments demonstrate that these monoclonal antibodies recognize key protective antigens in currently licensed human and veterinary whole cell Leptospira vaccines. The high precision and robustness renders the two ELISAs much more reliable correlates of potency in dogs than the hamster potency test. The recent approval of these assays for a new canine leptospirosis vaccine is an important contribution to the 3Rs in quality control testing of Leptospira vaccines., (Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2013
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