Developments in biological standardization最新文献_第10页

Control of foot-and-mouth disease by vaccination. 通过接种疫苗控制口蹄疫。

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

F Brown

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Regulation of biologicals in the European Union. 欧盟对生物制品的监管。

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

G Vicari

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ICH activities on biotech topics. 生物技术主题的ICH活动。

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

P Zorzi-Morre

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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

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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

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Detecting viruses in sera: methods used and their merits. 检测血清中的病毒:所用方法及其优点。

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

A Jennings

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Detection of endotoxins and other pyrogens using human whole blood. 利用人全血检测内毒素及其它热原。

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

S Fennrich, M Fischer, T Hartung, P Lexa, T Montag-Lessing, H G Sonntag, M Weigandt, A Wendel

{"title":"Detection of endotoxins and other pyrogens using human whole blood.","authors":"S Fennrich, M Fischer, T Hartung, P Lexa, T Montag-Lessing, H G Sonntag, M Weigandt, A Wendel","doi":"","DOIUrl":"","url":null,"abstract":"When cells of the immune system, i.e. primarily blood monocytes and macrophages, come into contact with pyrogens (fever-inducing contaminations) they release mediators transmitting the fever reaction through the organism to the thermoregulatory centres of the brain. The new test discussed here exploits this reaction for the detection of pyrogens: human whole blood taken from healthy volunteers is incubated in the presence of the test sample. If there is pyrogen contamination, the endogenous pyrogen interleukin-1 is released, which is then determined by ELISA. According to the pharmacopoeia, the rabbit pyrogen test determines the fever reaction following injection of a test sample. In comparison, the new whole blood assay is more sensitive, less expensive and determines the reaction of the targeted species. Compared to the well established in vitro alternative, i.e. the limulus amebocyte lysate assay (LAL), the new blood assay is not restricted to endotoxins of gram-negative bacteria, it is not affected by endotoxin-binding blood proteins and it reflects the potency of different endotoxin preparations in mammals. Here, interim results of the ongoing optimization and pre-validation are reported and the present state of the evaluation for biological and pharmaceutical drugs are presented.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"131-9"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21424990","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}

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Efficient inactivation of viruses and mycoplasma in animal sera using UVC irradiation. UVC辐照对动物血清中病毒和支原体的有效灭活。

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

J Kurth, R Waldmann, J Heith, K Mausbach, R Burian

{"title":"Efficient inactivation of viruses and mycoplasma in animal sera using UVC irradiation.","authors":"J Kurth, R Waldmann, J Heith, K Mausbach, R Burian","doi":"","DOIUrl":"","url":null,"abstract":"Transmission of viruses by animal sera represents a considerable risk for humans and animals particularly when the serum is used for the production of pharmaceutical products such as vaccines. Procedures applicable for inactivating large numbers of different viruses, both enveloped and non-enveloped, are therefore mandatory. For this purpose we have developed and validated UVC irradiation as the virus-inactivation procedure of choice for serum to be used in an industrial setting. Spiking experiments in foetal calf serum (FCS) were performed by independent contract laboratories and revealed constantly high clearance rates for various viruses such as bovine parvovirus, parainfluenza type III virus, bovine diarrhoea virus, foot-and-mouth disease virus and different forms of mycoplasmas. UVC-treated sera maintained their growth-promoting activities for various cell types (MRC-5, Vero, CHO). Conventional growth curves generated in the presence of 10% and 1% UVC-treated FCS differed only slightly from controls, indicating the lack of significant damage during UVC exposure. Experiments using a sensitive photometric-based acid phosphatase assay (APA), which correlates well with the more tedious cell counting procedure, confirmed these findings even in the presence of minimal serum requirements. UVC treatment of animal sera appears advantageous compared to currently recommended inactivation procedures, such as Gamma irradiation, for at least three reasons: (i) it possesses a high inactivation capacity for parvoviruses, a pathogen that cannot be destroyed easily by conventional methods; (ii) it causes no noticeable impairment in cell growth and (iii) it can be performed in a controlled manner at the production site.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"99 ","pages":"111-8"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21271086","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}

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Development of a Vero cell-derived influenza whole virus vaccine. Vero细胞衍生流感全病毒疫苗的研制

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

O Kistner, P N Barrett, W Mundt, M Reiter, S Schober-Bendixen, G Eder, F Dorner

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Evaluation of toxin neutralisation in test systems for diphtheria antibody assessment. 白喉抗体评估测试系统中毒素中和作用的评价。

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

J Vandenberg, J W van der Gun, C F Hendriksen

{"title":"Evaluation of toxin neutralisation in test systems for diphtheria antibody assessment.","authors":"J Vandenberg, J W van der Gun, C F Hendriksen","doi":"","DOIUrl":"","url":null,"abstract":"Over the past years, various authors have reported that the amount of toxin used in toxin neutralisation (TN) assays for diphtheria appears to influence the resulting relative antibody titre. Antibody affinity is thought to be an influencing factor. To confirm this observation and study the underlying mechanism of toxin neutralisation, a panel of sera was generated, differing in species of origin (mouse, guinea pig, and rabbit) and in affinity by using different immunisation schedules. The panel was then tested in relevant TN test systems for diphtheria antibody titration, namely the VERO cell test, the Toxin Binding Inhibition (ToBI) assay and the in vivo skin test in guinea pigs. A hyperimmune equine reference serum was used as the standard. Antibody affinity was measured in two different affinity ELISAs, the ammonium thiocyanate elution ELISA and the diethylamine inhibition ELISA. The VERO cell test clearly demonstrates the phenomenon; the higher the toxin dose used in the assay, the higher the resulting relative potency. The difference in relative antibody titre decreases as antibody affinity increases. This is especially evident when an equine hyperimmune reference serum is used as the standard. When a species homologous reference is used, the phenomenon is less distinct. The ToBI test, however, does not show the phenomenon. This discrepancy between these two test systems is being further investigated, and comparison will be made with the in vivo TN test. The findings confirm and support earlier observations. It is still unclear exactly which mechanisms are involved in the toxin neutralisation process. Antibody subclasses and class switching could play a role and will be further studied.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"105-11"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21424986","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}

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