Alternatives to Animal Testing in the Quality Control of Immunobiologicals: Current Status and Future Prospects

Hendriksen, Coenraad; Garthoff, Bernward; Aggerbeck, Henrik; Bruckner, Lucas; Castle, Peter; Cußler, Klaus; Dobbelaer, R.; Donk, H. Van De; Gun, Johan van der; Lefrancois, Sylvie; Milstien, Julie B.; Minor, Philip D.; Mougeot, H.; Rombaut, Bartholomeus; Ronneberger, H.; Spieser, Jean-Marc; Stolp, Ruurd; Straughan, Donald W.; Tollis, Maria; Zigtermans, G.

doi:10.1177/026119299402200606

Cited by 12 publications

(9 citation statements)

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“…The use of cell lines has not only reduced the number of animals but also ensured the adequate safety and efficacy of vaccines (Table 2). 15,30 Various human vaccine monographs of IP 1996 consisted of production methods involving animals. Over the last 2 decades, remarkable progress has been made to replace animals with alternate methods/techniques for the production of vaccines.…”

Section: Ip Initiativementioning

confidence: 99%

Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia

Rastogi

Kalaivani

Bhatia

et al. 2015

Ther Innov Regul Sci

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Quality and safety tests are required for regulatory approval of drugs and pharmaceuticals in the country to guarantee minimum safety standards, and most of these tests include animal usage. In the case of biological medicines, these safety and quality tests have to be performed on a batch-to-batch basis and require a large number of animals. Russell and Burch's 1959 principle of the 3 Rs- replacement, reduction, and refinement-is now being increasingly adopted worldwide, and various national and international pharmacopoeias have taken initiatives to safeguard animals. This article details the Indian Pharmacopoeia Commission's initiative to implement the 3 Rs through the Indian Pharmacopoeia. Explored are the deletion of animal tests, such as the abnormal toxicity test at final lot for biologicals; the replacement of in vivo methods by in vitro methods; the reduction in the number of animals used where deletion of the animal test is not possible; and the refinement of tests to cause minimal suffering to the animals. In Indian Pharmacopoeia 2014, pyrogen testing using rabbits has been replaced by the bacterial endotoxin test in the majority of biological monographs-keeping in view international trends and, especially for vaccine monographs, validated in vitro tests such as the bacterial endotoxin test as an alternative to the pyrogen test where justified and authorized. Steps are taken for introducing a single-dilution assay for the potency testing of diphtheria and tetanus vaccine (adsorbed) with the aim of minimizing number of animals used. The justified and authorized use of animals in drug manufacturing, analytic laboratories, and research will not only help in the expedited development/production of drugs but also be useful in protecting and promoting animal health.

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Section: Ip Initiativementioning

confidence: 99%

Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia

Rastogi

Kalaivani

Bhatia

et al. 2015

Ther Innov Regul Sci

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“…A total of nine workshops have been held to date in relation to biologicals, and eight reports have been published in ATLA in the ECVAM Workshop Report series (3)(4)(5)(6)(7)(8)(9)(10) and can be downloaded from ECVAM's Scientific Information Service website (http://ecvam-sis.jrc.it/). The report of the latest workshop on Three Rs approaches in the quality control of rabies vaccines is in preparation; its outcome was addressed by Bruckner et al (11) at the Congress.…”

Section: Ecvam Workhopsmentioning

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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“…Eight workshops have been held on topics relating to biologicals, and their reports have been published in the ECVAM workshop report series in ATLA (4)(5)(6)(7)(8)(9)(10)(11). They cover replacement of animal tests, as well as reduction and refinement.…”

Section: Ecvam Workhopsmentioning

confidence: 99%

ECVAM's Contributions to the Implementation of the Three Rs in the Production and Quality Control of Biologicals

et al. 2002

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A summary is presented of the activities initiated, and the progress achieved, between April 1993 and December 2001 in implementing the Three Rs in one of the main priority areas of the European Centre for the Validation of Alternative Methods (ECVAM) — the production and quality control of biologicals. These have included organising eight key workshops, and financial contributions to, and sponsorship of, relevant international workshops, symposia and conferences. Noteworthy activities include financial support and/or participation in a number of prevalidation and validation studies. These involved alternative methods for the batch potency testing of: human tetanus vaccines; human and veterinary tetanus antisera and immunoglobulin; rabies vaccines; Leptospira hardjo vaccines; Clostridium perfringens vaccines; and erysipelas vaccines. They also involved a cell culture test for specific toxicity testing of diphtheria toxoid vaccines. In addition, ECVAM funded a study on the use of humane endpoints for vaccine quality control tests involving severe suffering, such as the potency testing of erysipelas, rabies and pertussis vaccines. ECVAM has also contributed financially to the compilation of manuals and expert reports, and to training in test methods. Following the report of an ECVAM Task Force, ECVAM financially supported the prevalidation of some in vitro methods for the potency testing of a recombinant hormone. A proposal is presented for promotion of regulatory acceptance, and suggestions are made for possible future activities.

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Alternatives to Animal Testing in the Quality Control of Immunobiologicals: Current Status and Future Prospects

Cited by 12 publications

References 0 publications

Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia

Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia

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

ECVAM's Contributions to the Implementation of the Three Rs in the Production and Quality Control of Biologicals

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