Developments in biological standardization最新文献_第3页

The development of non-animal-based bioassays for cytokines and growth factors. 细胞因子和生长因子非动物生物检测方法的发展。

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

A R Mire-Sluis

{"title":"The development of non-animal-based bioassays for cytokines and growth factors.","authors":"A R Mire-Sluis","doi":"","DOIUrl":"","url":null,"abstract":"Cytokines (including growth factors) exist as a family of proteins that possess a vast array of pleiotropic biological activities and therapeutic potential. As with any biological therapeutic, appropriate assessment of biological potency is vital to the development of cytokines as medicinal products. In early investigations of cytokine activity, in vivo bioassays were used to assess the whole body effects of cytokines in animals. The identification of the cellular targets of each cytokine allowed the extraction of tissue and the use of cells to produce in vitro bioassays, with the drastic reduction in the number of animals required. The discovery of cytokine-responsive tumours introduced a range of immortal, homogeneous tumour cell lines that are dependent on cytokines for proliferation. This allows cell lines to be made available for general distribution to laboratories internationally for bioassays, without the need for animals. More recently, the use of recombinant DNA technology to clone the specific receptor for the cytokine required for bioassay into an unresponsive cell line has led to a highly specific 'receptor-transduced' cell line. The most recent advances include the development of receptor signalling-based biochemical bioassays for cytokines.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"169-75"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21424994","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

Validation of in vitro assays for botulinum toxin: a case study. 肉毒杆菌毒素体外测定法的验证:一个案例研究。

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

R E Gaines Das, A B Heath, H Martin, D Sesardic

引用次数: 0

Serological assays as alternatives to the Ph Eur challenge test for batch release of tetanus vaccines for human use. 血清学分析可替代Ph Eur攻击试验，用于批量释放供人使用的破伤风疫苗。

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

R Winsnes, C Hendriksen, D Sesardic, A Akkermans, A Daas

{"title":"Serological assays as alternatives to the Ph Eur challenge test for batch release of tetanus vaccines for human use.","authors":"R Winsnes, C Hendriksen, D Sesardic, A Akkermans, A Daas","doi":"","DOIUrl":"","url":null,"abstract":"According to the European Pharmacopoeia (Ph Eur) monograph on Tetanus Vaccine (adsorbed) (1997: 0452), assessment of potency is based on a challenge test in guinea pigs or mice. The end-point is taken as paralysis or death. The test requires a large number of animals and causes severe distress. The aim of the present study was to refine the test, and reduce the number of animals needed, for batch release purposes. Serological assays having the potential of being internationally accepted, have been compared with Ph Eur assays. The study included five tetanus vaccines of various combinations and produced by different manufacturers. The results indicated an excellent correlation between enzyme-linked immunosorbent assay (ELISA) and the challenge test (about 93% predictive value), as well as between the toxin binding inhibition (ToBI) test and the challenge test (about 95% predictive value) and between ELISA and the ToBI test (r = 0.92). Antitoxin concentrations determined by ELISA and ToBI were generally in the same range. An overall good correlation was also seen for serum pools of the guinea pigs injected with equal vaccine doses, between toxin neutralisation test in mice (TNT) and ELISA (r = 0.93) as well as between TNT and ToBI (r = 0.97). The ultimate goal of this project was to determine whether serological assays can be used for testing combined vaccines, particularly for tetanus and diphtheria components, using sera from the same animals.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"277-88"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21426115","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

Statistical evaluation of numbers of animals to be used in vaccine potency testing: a practical approach. 用于疫苗效力测试的动物数量的统计评估:一种实用的方法。

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

A M Akkermans, C F Hendriksen

{"title":"Statistical evaluation of numbers of animals to be used in vaccine potency testing: a practical approach.","authors":"A M Akkermans, C F Hendriksen","doi":"","DOIUrl":"","url":null,"abstract":"Some of the guidelines for potency testing of vaccines issued by regulatory bodies such as the European Pharmacopoeia (EP) and WHO are detailed and stringent (e.g. EP monograph for Newcastle Disease (ND) Vaccine (inactivated)), whereas others only stipulate that the number of animals used should be sufficient to meet the required accuracy (e.g. EP monograph for Hepatitis A vaccine (inactivated)). Simulation studies in our laboratory using historical ND potency test data indicated that the number of animals specified in the monograph is too high; a considerable reduction from 10 to seven animals per group does not substantially influence the precision of the results. Multipoint models (e.g. EP monograph for Tetanus Vaccine (adsorbed)) require at least three dilutions per vaccine for testing for response linearity. However, when historical data clearly show that in the range used the response curves are linear, it is superfluous to verify this in every test. Furthermore, linearity has little priority for a valid parallel line assay calculation. A simulation study using historical Diphtheria potency test data showed that calculations using two dilutions per vaccine in relatively small groups of animals produced results comparable to those obtained from the full assay. This procedure still enables calculation of the relative potency, in contrast to the 1 + 1 method, which gives only a pass or fail result, while the number of animals required is only slightly higher. This method could be applied in cases where the 1 + 1 method fails. In conclusion, by providing guidelines on methods in which proven consistency in production and testing may be taken into account, manufacturers are more stimulated to look for other (cheaper) ways to test the potency of a vaccine using less animals.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"255-60"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21426761","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

Chromatography of recombinant proteins. 重组蛋白色谱法。

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

J V O'Connor

引用次数: 0

Bioassays for the characterisation and control of therapeutic cytokines; determination of potency. 用于表征和控制治疗性细胞因子的生物测定;效价测定。

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

R Thorpe, M Wadhwa, C Page, A Mire-Sluis

{"title":"Bioassays for the characterisation and control of therapeutic cytokines; determination of potency.","authors":"R Thorpe, M Wadhwa, C Page, A Mire-Sluis","doi":"","DOIUrl":"","url":null,"abstract":"The primary value of bioassays is that they alone directly assess the biological activity of bioactive substances and products like cytokines. Appropriately designed bioassays reflect the fundamental aspects of the biological activity of a cytokine molecule, including ligand-receptor binding, signal transduction processes (often poorly understood) and the final observed biological effects. Biological assays therefore complement physicochemical and biochemical procedures which normally only assess precise molecular structural features of cytokines. Bioassays provide valuable information concerning the potency of cytokine products. This is essential for evaluating batch-to-batch consistency, appropriate formulations and stability. Bioassay data are crucial at all stages in the development of cytokine products, from early research to final quality control of finished product. However, the type and design of bioassays may differ according to the information required and its intended use. The assays may or may not directly relate to the clinical use of the product. Bioassays can be difficult to perform and time consuming, although this often reflects bad assay choice and/or design. Correct analysis of the assay results is essential if valid data are to be obtained. Standardisation, using correctly calibrated primary and secondary standards, is essential. In vivo bioassays are normally more unreliable than in vitro procedures, but in some cases in vitro systems are either not available or do not address important biological characteristics of a product. Bioassays must be validated for their intended purpose and for the types of samples to be measured. Appropriate statistical analysis should be used to derive the significance and specifications of results. This needs to address both variability in samples and assay performance. Specifications (limits) for product acceptability need to be derived from real data using several batches of cytokine product.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"97 ","pages":"61-71"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21327218","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

Bioassays and biological stability. 生物测定和生物稳定性。

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

J F Wright

引用次数: 0

A comparison of physico-chemical and biological assays in the batch release of therapeutic cytokines. 治疗性细胞因子批量释放的理化和生物学分析比较。

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

A F Bristow

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The role of Pharmacopoeia standards and monographs. 药典标准和专著的作用。

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

A Artiges

引用次数: 0

Inactivated influenza vaccines prepared in cell culture. Symposium proceedings. Potters Bar, United Kingdom, September 26-27, 1997. 细胞培养制备的灭活流感疫苗。研讨会论文集。波特酒吧，英国，1997年9月26-27日。

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

引用次数: 0