Developments in biological standardization最新文献_第9页

A 4R concept for the safety testing of immunobiologicals. 免疫生物制剂安全性测试的4R概念。

Developments in biological standardization Pub Date : 1999-01-01

K Cussler

{"title":"A 4R concept for the safety testing of immunobiologicals.","authors":"K Cussler","doi":"","DOIUrl":"","url":null,"abstract":"Safety tests in animals are an important part of the licensing procedures for human and veterinary medicines. Pharmacopoeial and other legal regulations require immunobiologicals to be approved for safety on a batch-to-batch basis. A large number of animals is needed to perform these general and specific safety tests. The search for alternatives according to the famous 3R concept proposed by Russel & Burch [1] is also relevant to safety tests. This session of the conference will highlight recent progress in the application of this concept. However, before considering potential alternatives to a test, it is advisable to re-evaluate the necessity of the safety test in question. Many animal-based safety test procedures were introduced because the production of biologicals was difficult and methods to control this production were limited. Nowadays much progress has been achieved due to a better knowledge of the prophylaxis of infectious diseases and the standardisation of methods of production and control. Therefore, some animal tests may no longer be necessary. A good example of this is the deletion of the abnormal toxicity test from the European Pharmacopoeia. Efforts to limit the use of animals in the quality control of immunobiologicals should therefore include a reassessment of the value of the safety test. Consequently, reassessment should be the first R used to evaluate whether an animal test can be removed. The 3R concept of Russel & Burch [1] to replace, reduce and refine animal tests has to be considered if that does not prove to be possible.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"121-6"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21424988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Reduction in animal use in the production and testing of biologicals. 减少在生物制品的生产和测试中使用动物。

Developments in biological standardization Pub Date : 1999-01-01

M F Festing

引用次数: 0

Tetanus antibodies measured by the toxin binding inhibition test (ToBI) in mothers and children in the Neonatal Tetanus Program in Vietnam. 在越南新生儿破伤风项目中，用毒素结合抑制试验(ToBI)测定母亲和儿童的破伤风抗体。

Developments in biological standardization Pub Date : 1999-01-01

N Q Anh, H A Hong, T N Nhon, N D Thinh, N T Van, J Hendriks

{"title":"Tetanus antibodies measured by the toxin binding inhibition test (ToBI) in mothers and children in the Neonatal Tetanus Program in Vietnam.","authors":"N Q Anh, H A Hong, T N Nhon, N D Thinh, N T Van, J Hendriks","doi":"","DOIUrl":"","url":null,"abstract":"The immunoresponse to vaccination in the Neonatal Tetanus Program (NNT) for pregnant women was studied in Vietnam using the Toxin Binding Inhibition Test (ToBI). The vaccination schedule consisted of two primary doses of adsorbed tetanus toxoid (TT) vaccine given with a one month interval. The seroconversion rate in the women was 98%. Two and a half months after birth, 63% of the children born from these women had tetanus antibody values higher than 0.01 IU/ml. Four women who had anti-tetanus titres < 0.01 IU/ml at delivery, despite two doses of primary vaccination, received a third booster with vaccine one year after the first injection. Their antibody levels were well above 0.01 IU/ml one month after this additional booster, suggesting that (when economically feasible) a third TT injection could be considered into the NNT to confer optimal anti-tetanus antibody levels in women for subsequent pregnancies. This study confirmed the effectiveness of the TT vaccines investigated and indicates their potential to replace, in immunosurveillance studies under field conditions, the in vivo mouse neutralisation test by in vitro alternative methods such as the ToBI test.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"247-53"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21426760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Regulatory perspective in the United States on cell cultures for production of inactivated influenza virus vaccines. 美国对生产灭活流感病毒疫苗的细胞培养的监管观点。

Developments in biological standardization Pub Date : 1999-01-01

R A Levandowski

引用次数: 0

Novel assays for the detection of botulinum toxins in foods. 食品中肉毒杆菌毒素检测的新方法。

Developments in biological standardization Pub Date : 1999-01-01

M Wictome, K A Newton, K Jameson, P Dunnigan, S Clarke, J Gaze, A Tauk, K A Foster, C C Shone

引用次数: 0

Poultry vaccines: an analysis of the animal trials required for vaccine testing and the way to reduce or refine these tests. 家禽疫苗:分析疫苗试验所需的动物试验以及减少或改进这些试验的方法。

Developments in biological standardization Pub Date : 1999-01-01

C Jungbäck, B Küchler, E M Schirk

{"title":"Poultry vaccines: an analysis of the animal trials required for vaccine testing and the way to reduce or refine these tests.","authors":"C Jungbäck, B Küchler, E M Schirk","doi":"","DOIUrl":"","url":null,"abstract":"The testing of vaccines for use in chickens requires a large number of animal trials. Especially for poultry vaccines, quality testing of each batch consists of testing for extraneous agents in chickens for all products and potency tests for inactivated products. For the licensing of a vaccine a number of safety and efficacy tests is necessary. The safety testing covers dose and overdose studies, and the influence on reproductive performances and immunological functions. For live vaccines some additional trials concerning spread of vaccine strains, dissemination in the vaccinated animals and reversion to virulence are required. Some possibilities for combining several tests are presented. The purpose is to reduce the number of animals needed in these trials. The efficacy testing mostly requires challenge tests to define onset, level and duration of immunity. Serological test systems to replace the challenges are rarely implemented. The example of efficacy testing of infectious bursal disease vaccines demonstrates the possible replacement of a challenge by a serological test system. Parameters are morbidity, mortality, histological findings, bursa/body-ratios, and humoral antibodies detected by serum neutralization and ELISA.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"79-83"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21425044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of a nitric oxide induction assay as a potential replacement for the intracerebral mouse protection test for potency assay of pertussis whole cell vaccines. 开发一氧化氮诱导试验作为百日咳全细胞疫苗效价测定的潜在替代脑内小鼠保护试验。

Developments in biological standardization Pub Date : 1999-01-01

C Canthaboo, D Xing, M Corbel

{"title":"Development of a nitric oxide induction assay as a potential replacement for the intracerebral mouse protection test for potency assay of pertussis whole cell vaccines.","authors":"C Canthaboo, D Xing, M Corbel","doi":"","DOIUrl":"","url":null,"abstract":"The intracerebral mouse protection test (Kendrick test) for the potency assay of pertussis vaccines is a complex and time consuming in vivo test which has a significant intra- and interlaboratory variation. Thus, there is a pressing need to develop a replacement for the Kendrick test. There is now convincing evidence to suggest that Bordetella pertussis can be taken up and survive within macrophages in the lungs and that cell-mediated immunity plays a role in protection. It was hypothesised that murine macrophages could be activated by immunisation with whole cell pertussis vaccines and therefore induce NO production. An alternative in vitro assay based on the determination of reactive nitrogen intermediates produced as a result of macrophage activation has been examined as a possible replacement for the current intracerebral (i.c.) mouse protection test. NO induction was studied in the peritoneal macrophages of female NIH mice immunised with normal and denatured whole cell B. pertussis vaccines respectively. Compared with controls receiving diluent only, macrophages and spleen cells from mice immunised with whole cell pertussis vaccine responded in vitro to selected pertussis antigens by NO synthesis. The production of NO in response to in vitro culture with bacterial antigen was immunisation dose dependent and was correlated with protective immunity in vivo as determined by i.c. challenge. The results suggest that NO production may serve as a marker of macrophage activation in mice immunised with whole cell vaccine, and could form the basis of a potential replacement potency assay.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"95-103"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21425046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Alternatives and developing countries. 替代品和发展中国家。

Developments in biological standardization Pub Date : 1999-01-01

J B Milstien, N Dellepiane

引用次数: 0

Use of the single dilution test for the EP tetanus toxoid potency assay. EP破伤风类毒素效价测定的单一稀释试验。

Developments in biological standardization Pub Date : 1999-01-01

B L McKee

引用次数: 0

Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use. London, United Kingdom, September 24-26, 1998. Proceedings. 人类和兽医用生物制品的开发和控制中的动物替代品。1998年9月24日至26日，英国伦敦。程序。

Developments in biological standardization Pub Date : 1999-01-01

引用次数: 0