Developments in biological standardization最新文献_第9页

A Phase I, randomized controlled clinical trial to study the reactogenicity and immunogenicity of a new split influenza vaccine derived from a non-tumorigenic cell line. 一项I期随机对照临床试验，研究从非致瘤细胞系衍生的新型分裂流感疫苗的反应原性和免疫原性。

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

P B Percheson, P Trépanier, R Dugré, T Mabrouk

{"title":"A Phase I, randomized controlled clinical trial to study the reactogenicity and immunogenicity of a new split influenza vaccine derived from a non-tumorigenic cell line.","authors":"P B Percheson, P Trépanier, R Dugré, T Mabrouk","doi":"","DOIUrl":"","url":null,"abstract":"We have found that our MDCK-derived cell line (BV-5F1) is non-tumorigenic in tests conducted in accordance with FDA guidelines, and thus may be suitable for producing live, attenuated or inactivated vaccine. The cell line has been extensively tested for the presence of contaminating microorganisms. No infectious agents of viral or other microbial origin were present. Using the BV-5F1 cell line, we have now designed a process for the large-scale production of influenza virus for the manufacture of a vaccine. The production system involves expansion of cells anchored on a microcarrier using stirred fermenters, followed by virus infection. Viral particles are purified in a way similar to the licensed egg-derived vaccine Fluviral SF and mainly involves ultracentrifugation, ultrafiltration and formaldehyde inactivation. The final product is a split inactivated vaccine. A randomized, double-blind clinical study was made in healthy adults using the new split influenza vaccine derived from viruses grown in cell culture (bivalent formulation). The results of this Phase I study have demonstrated that the split influenza vaccine derived from cell culture is highly immunogenic and safe in adults.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"98 ","pages":"127-32; discussion 133-4"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21358930","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

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

Gamma irradiation of bovine sera. 牛血清的γ辐照。

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

M Z Plavsic, J P Daley, D J Danner, D J Weppner

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

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 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

Risks of virus transmission associated with animal sera or substitutes and methods of control. 与动物血清或代用品相关的病毒传播风险及控制方法。

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

M Eloit

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

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