{"title":"A cell attachment assay for use in the standardization of serum products","authors":"Donald J. Giard","doi":"10.1016/0092-1157(88)90002-9","DOIUrl":"10.1016/0092-1157(88)90002-9","url":null,"abstract":"<div><p>A culture tube assay has been developed which can be used to measure relative amounts of cell attachment activity present in different batches of serum or serum products. The assay utilizes a transformed line of BHK-21 cells which is highly dependent upon serum factors for attachment when the cells are subjected to mild liquid shear forces (tube rotation of 1 rpm). Approximately fivefold differences in attachment activity were observed between different batches of bovine calf serum, while up to 20-fold differences were observed between different batches of horse serum. Less than twofold differences were seen between different lots of fetal bovine serum. The assay appears to have application as a quality control measure for screening serum products.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 3","pages":"Pages 147-155"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90002-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14300042","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}
{"title":"The use and standardization of combined vaccines. Report of the 19th Congress of IABS. International Association of Biological Standardization. 10-13 December, 1985, Amsterdam, The Netherlands. Summaries and recommendations.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 3","pages":"281-5"},"PeriodicalIF":0.0,"publicationDate":"1987-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14731981","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}
{"title":"Quantitative estimation of diphtheria and tetanus toxoids. 2. Single radial immuno-diffusion tests (Mancini) and rocket immuno-electrophoresis test in comparison with the flocculation test","authors":"Lene Ljungqvist , Jørn Lyng","doi":"10.1016/0092-1157(87)90019-9","DOIUrl":"10.1016/0092-1157(87)90019-9","url":null,"abstract":"<div><p>The concentration in Lf units, of an unknown diphtheria or tetanus toxoid preparation is estimated in the flocculation test relative to reference preparations of tetanus and diphtheria antitoxins, respectively. By replacing the antitoxin reference preparations with toxoid reference preparations it should be possible to use immunological methods other than the flocculation test for the quantitative estimation of toxoids in Lf units.</p><p>A number of diphtheria and tetanus toxoids were tested by rocket immuno-electrophoresis and single radial immuno-diffusion (Mancini test). The concentrations of the unknown toxoids were expressed relative to a diphtheria toxoid calibrated in Lf units (DIFT) and a tetanus toxoid calibrated in Lf units (TEFT), respectively. These two toxoid preparations are regarded as candidates for establishment as international standard preparations. The results obtained in the two tests were compared with those obtained in the flocculation test. In most cases the differences between the results did not exceed 10%. It is concluded, therefore, that the rocket electrophoresis or the radial immuno-diffusion tests can be used as alternatives to the flocculation test.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 1","pages":"Pages 79-86"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90019-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14235610","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}
Morag Ferguson , Brenda Wachmann , Charles F. Needy , Edward A. Fitzgerald
{"title":"The effect of strain differences on the assay of rabies virus glycoprotein by single radial immunodiffusion","authors":"Morag Ferguson , Brenda Wachmann , Charles F. Needy , Edward A. Fitzgerald","doi":"10.1016/0092-1157(87)90018-7","DOIUrl":"10.1016/0092-1157(87)90018-7","url":null,"abstract":"<div><p>Antigenic differences between rabies virus strains used for vaccine manufacture can be demonstrated using monoclonal antibodies. We have shown that these differences are sufficiently large to affect the potency values of vaccines measured in single radial immunodiffusion (SRD) assays if the reference and test vaccines are antigenically heterologous. The production of reagents for use in SRD assays for each strain of rabies virus should be considered.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 1","pages":"Pages 73-77"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90018-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14236482","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}
{"title":"A comparison of the indirect haemagglutination test with the toxin neutralization test for the estimation of diphtheria antitoxin in mouse sera","authors":"S.C. Maheshwari , Suniti B. Sharma , Subhash Ahuja , S.N. Saxena","doi":"10.1016/S0092-1157(87)80004-5","DOIUrl":"10.1016/S0092-1157(87)80004-5","url":null,"abstract":"<div><p>Serum samples from 42 groups of mice immunized for different immunization periods wich various doses of Adsorbed Diphtheria-Tetanus Vaccine, Adsorbed Diphtheria-Tetanus and Pertussis Vaccine and a standard diphtheria toxoid were assayed for their diphtheria antitoxin content by indirect haemagglutination (IHA) and by toxin neutralization (TN) tests. A very good correlation of 0.91 was obtained between the results of the two methods. There was no statistically significant difference between the IHA and the TN titres obtained. Adsorption with sheep red cells and treatment of the sera with 2-mercaptoethanol had no effect on the IHA titres. The minimum level of antitoxin detectable by the IHA test was 0.00039 IU ml<sup>-1</sup>. IHA proved to be a sensitive, specific and reproducible method which can be used reliably for the assay of diphtheria antitoxin in mouse sera.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 4","pages":"Pages 315-321"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(87)80004-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14800224","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}
C.F.M. Hendriken , J. W. v. d Gun , F.R. Marsman , J.G. Kreeftenberg
{"title":"The effects of reductions in the numbers of animals used for the potency assay of the diphtheria and tetanus components of adsorbed vaccines by the methods of the european pharmacopoeia","authors":"C.F.M. Hendriken , J. W. v. d Gun , F.R. Marsman , J.G. Kreeftenberg","doi":"10.1016/S0092-1157(87)80008-2","DOIUrl":"10.1016/S0092-1157(87)80008-2","url":null,"abstract":"<div><p>Forty eight assays of adsorbed diphtheria vaccine and seven assays of adsorbed tetanus vaccine using either a lethal challenge (38 assays) or a serum neutralization test (17 assays) were evaluated for the effects of reductions in the number of animais used at each dilution on the potency values and 95% confidence intervals. The results were assessed in the light of the requirements of the European Pharmacopoeia and the WHO.</p><p>In the majority of assays, 50% of the number of animals presently required would have sufficed for the determination of a potency within the limits of confidence stipulated by the European Pharmacopoeia and the WHO. Therefore it is concluded that a simplified assay with a reduced number of animals is suitable for the routine potency testing of the diphtheria and tetanus components of the combined vaccines and the monovalent that were examined. Flexibility in the national and international requirements in respect of the numbers of animals used at each dilution is suggested for the routine potency assay of the diphtheria and tetanus components of adsorbed vaccines.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 4","pages":"Pages 353-362"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(87)80008-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14800227","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}
{"title":"The persistence of antibodies induced by meningococcal polysaccharides of groups A and C in human volunteers","authors":"Sajida M. Al-Shamma , Maha R. Al-Sa'ad","doi":"10.1016/S0092-1157(87)80010-0","DOIUrl":"10.1016/S0092-1157(87)80010-0","url":null,"abstract":"<div><p>Ninety-nine college students (58 males and 41 females) aged 17 to 23 years were each injected subcutaneously with 50 μg of meningococcal polysaccharides A and C. Titrations of antisera obtained at various time intervals during the two subsequent years were made by passive haemagglutination microtitration using human O Rh-negative red blood cells from a single source. The percentage of responders (those who developed a fourfold increase in titre) to polysaccharide A was 97.9% and that to polysaccharide C was 94.8%. Pre-immunization titres of 16 to polysaccharide A and 8 to polysaccharide C were considered to be threshold values above which the response might be impaired. There was a significant (P < 0.01) difference in the geometric mean HA titre between vaccinees and control groups after vaccination at each time interval studied. The majorities of both the vaccinees and the controls had a higher peak titre to polysaccharide A than to polysaccharide C.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 4","pages":"Pages 373-378"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(87)80010-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14800229","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}
{"title":"Titrage biologique de l'hormone humaine de croissance","authors":"M. Parès , A. El Zaouk , J. Giroux","doi":"10.1016/S0092-1157(87)80009-4","DOIUrl":"https://doi.org/10.1016/S0092-1157(87)80009-4","url":null,"abstract":"<div><p>Les normes phamaceutiques norvégiennes et danoises décrivent une méthode de titrage biologique de l'hormone humaine de croissance (STH) basée sur l'augmentation de l'épaisseur du cartilage épiphysaire du tibia (test Tibia) de jeunes rats hypophysectomisés. De nombreux auteurs utilisent pour ce titrage un test de croissance pondérale (test Evans) également chez des jeunes rats hypophysectomisés. Devant le souhait général de limitation de l'utilisation des animaux de laboratoire et avec l'apparition de produits obtenus par génie génétique nous avons voulu d'une part vérifier l'application de ces méthodes au titrage d'hormones biogénétiques et d'autre part tester la possibilité d'employer les deux méthodes simultanément chez les mêmes sujets.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 4","pages":"Pages 363-371"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(87)80009-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92098410","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}
{"title":"The effects of different inactivating agents on the potency, toxicity and stability of pertussis vaccine","authors":"R.K. Gupta , Suniti B. Sharma , Subhash Ahuja , S.N. Saxena","doi":"10.1016/0092-1157(87)90020-5","DOIUrl":"10.1016/0092-1157(87)90020-5","url":null,"abstract":"<div><p>The effect of heat (56 °C for 10 min), formaldehyde (0·1% at 37 °C for 24h), glutaraldehyde (0·05% at room temperature for 10 min), thimerosal (0·02% at 37 °C for 24 h), acetone-I (three treatments at room temperature) and acetone-II (three treatments at room temperature and fourth treatment at 37 °C), when used as inactivating agents in the preparation of pertussis suspension, was studied with regard to potency, toxicity and stability. Five batches each of <em>Bordetella pertussis</em> strains 134 and 509 were used for the study. The thimerosal inactivated pertussis (TIP) preparation was 1·5−2 times more potent than the heat inactivated pertussis (HIP) preparation. The potency values of the formaldehyde inactivated pertussis (FIP) and glutaraldehyde inactivated pertussis (GIP) preparations were similar to those of the HIP preparation, while the potencies of the acetone-I treated pertussis (A(I)TP) and acetone-II treated pertussis (A(II)TP) preparations were about half those of the HIP preparation. The FIP preparation was the least toxic showing maximum weight gain in the mouse weight-gain test (MGWT), while the TIP preparation did not pass the MWGT. The weight gains shown the GIP, A(I)TP and A(II)TP preparations were greater than those shown by the HIP preparation. The potency of pertussis component in the adsorbed diphtheria-pertussis-tetanus (DPT) vaccine was stable at 4–8 °C and 25 °C for three months for all types of pertussis vaccine. There was about 54–65% loss in the potency of the samples after three months at 35 °C. The inactivating agents used in the manufacture of pertussis preparations had no effect on the stability of the vaccine.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 1","pages":"Pages 87-98"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90020-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14235611","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}
{"title":"Glutaraldehyde inactivated pertussis vaccine: a less histamine sensitizing vaccine","authors":"R.K. Gupta , Suniti B. Sharma , Subhash Ahuja , S.N. Saxena","doi":"10.1016/0092-1157(87)90038-2","DOIUrl":"10.1016/0092-1157(87)90038-2","url":null,"abstract":"<div><p>The effects of different inactivating agents on the biological activity of the histamine sensitization factor of <em>Bordetella pertussis</em> toxin were examined. The agents were used for inactivation in the preparation of whole cell pertussis suspension. The histamine sensitizing activity was reduced to 36·9–13·3% by treatment with glutaraldehyde, to about 50% by treatment with formaldehyde and by the acetone-II treatment, relative to the reduction by heat treatment. Treatment with thimerosal and the acetone-I treatment did not reduce the histamine sensitizing activity as the 50% histamine sensitizing doses of the heat inactivated pertussis preparation, the thimerosal inactivated pertussis preparation and the acetone-1 treated pertussis preparation were very similar. Glutaraldehyde has thus been found to be a better inactivating agent for the preparation of a safe pertussis suspension as it considerably reduced the histamine sensitizing activity of pertussis toxin.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 2","pages":"Pages 159-164"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90038-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14241225","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}