Interlaboratory Validation of in vitro Serological Assay Systems to Assess the Potency of Tetanus Toxoid in Vaccines for Veterinary Use

Hendriksen, Coenraad; Woltjes, J.; Akkermans, Arnoud; Gun, J.W. van der; Marsman, F.R.; Verschure, Mirjam H.; Veldman, Kees

doi:10.1006/biol.1994.1037

Cited by 17 publications

(13 citation statements)

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“…In addition to rabies vaccines, workshop participants agreed that a synergy among experts in human and veterinary tetanus vaccines could facilitate and expedite the development of a replacement potency test for both of these vaccine products. Currently, in the United States and the EU, the potency tests for human and veterinary vaccines consist of vaccination of guinea pigs and serological evaluation of antitetanus toxoid antibodies by an indirect ELISA [44] or a toxin-binding inhibition (ToBI) test [45,47]. Efforts to develop a replacement test for either human or veterinary tetanus vaccines are impeded by the facts that toxoid vaccines are not well characterized, and potential analytical tests, including physiochemical and immunochemical tests, require much greater data generation, characterization, and validation for in-process and final product characterization [120].…”

Section: Clostridium Spp Vaccinesmentioning

confidence: 99%

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Kulpa-Eddy

Srinivas

Halder

et al. 2011

Procedia in Vaccinology

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NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. Six topics were addressed in detail by speakers and workshop participants and are reported in a series of six reports. This workshop report, the second in the series, provides recommendations for current and future use of nonanimal methods and strategies for veterinary vaccine potency testing. Workshop participants recommended that future efforts to replace animal use give priority to vaccines (1) that use large numbers of animals per test and for which many serials are produced annually, (2) that involve significant animal pain and distress during procedures, (3) for which the functional protective antigen has been identified, (4) that involve foreign animal/zoonotic organisms that are dangerous to humans, and (5) that involve pathogens that can be easily spread to wildlife populations. Vaccines identified as the highest priorities were those for rabies, Leptospira spp., Clostridium spp., Erysipelas, foreign animal diseases (FAD), poultry diseases, and fish diseases. Further research on the identification, purification, and characterization of vaccine protective antigens in veterinary vaccines was also identified as a priority. critical knowledge and data gaps, including opportunities to apply new science and technology. Recommendations included (1) investigations into the relative impact of various adjuvants on antigen quantification assays, (2) investigations into extraction methods that could be used for vaccines containing adjuvants that can interfere with antigen assays, and (3) review of the current status of rabies and tetanus human vaccine in vitro potency methods for their potential application to the corresponding veterinary vaccines. Workshop participants recommended enhanced international harmonization and cooperation and closer collaborations between human and veterinary researchers to expedite progress. Implementation of the workshop recommendations is expected to advance alternative in vitro methods for veterinary vaccine potency testing that will benefit animal welfare and replace animal use while ensuring continued protection of human and animal health.

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Section: Clostridium Spp Vaccinesmentioning

confidence: 99%

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Kulpa-Eddy

Srinivas

Halder

et al. 2011

Procedia in Vaccinology

View full text Add to dashboard Cite

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“…Table 1 gives an overview of these studies and their current status. In addition, one of the first successful validation studies in the field of biologicals, the validation of an ELISA procedure and the toxin binding inhibition (ToBI) test for the batch potency testing of tetanus vaccines for veterinary use in 1992, was based on funds allocated by the European Commission for ECVAM (16). The use of an in vitro serological method (for example, the ToBI test) was incorporated for batch potency testing into the relevant monograph, and after calibration of the reference sera in an international collaborative study organised by the EDQM, biological reference preparations are now available (17), and the monograph will come into force in 2003.…”

Section: Prevalidation and Validation Studiesmentioning

confidence: 99%

ECVAM's Activities in Promoting the Three Rs in the Quality Control of Biologicals

Halder

Balls

Hendriksen³

et al. 2004

Altern Lab Anim

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This paper summarises key activities initiated and the progress achieved between April 1993 and November 2002, in promoting the Three Rs in one of ECVAM's priority areas — the production and quality control of biologicals. These have included organising nine key workshops, financially supporting and/or participating in a number of prevalidation and/or validation studies, financial contributions and sponsorship to relevant international workshops, symposia and conferences, and financial support to the compilation of manuals, expert reports and training in test methods.

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“…ECVAM has contributed to several validation studies. In fact, one of the first successful studies, the validation of serological methods for the potency testing of tetanus vaccine for veterinary use, in 1992, was based on funding provided by the Commission for ECVAM (6). Furthermore, ECVAM has supported various other activities, such as the organisation of conferences and the evaluation of humane endpoints in vaccine potency testing.…”

Section: Ecvam's Activities In the Field Of Biologicalsmentioning

confidence: 99%

“…In 1992, a study began to validate the replacement of the TN test by three in vitro serological methods (6); an enzyme-linked immunosorbent assay (ELISA), the toxin binding inhibition (ToBI) test, and the haemagglutination (HA) test. The study was financed by the European Commission (formerly DG XI, now DG Environment).…”

Section: Tetanus Toxoid Vaccine For Veterinary Usementioning

confidence: 99%

ECVAM's Role in the Implementation of the Three Rs Concept in the Field of Biologicals

2002

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Biologicals can be defined as products that are derived from living organisms or are produced by them. They include vaccines, hormones, monoclonal and polyclonal antibodies, blood products and rDNA products. The production of conventionally produced biologicals requires an extensive batch-related quality control, to ensure that these products are both safe and potent. As several of the control tests rely on animal models, it is inevitable that large numbers of animals are used. Many initiatives have been undertaken in the last few decades to reduce, refine and replace the use of animals in this area. ECVAM has been involved in many activities to support the development, validation and implementation of these Three Rs methods. The role that ECVAM has played in a number of validation studies is summarised. It is concluded that ECVAM should continue to support the activities that have been shown to be successful, preferably in collaboration with the regulatory authorities.

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Interlaboratory Validation of in vitro Serological Assay Systems to Assess the Potency of Tetanus Toxoid in Vaccines for Veterinary Use

Cited by 17 publications

References 0 publications

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

ECVAM's Activities in Promoting the Three Rs in the Quality Control of Biologicals

ECVAM's Role in the Implementation of the Three Rs Concept in the Field of Biologicals

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