Morag Ferguson , Valerie Seagroatt , Geoffrey C. Schild
{"title":"A collaborative study to establish the international reference reagent for hepatitis B vaccine containing plasma-derived hepatitis B surface antigen","authors":"Morag Ferguson , Valerie Seagroatt , Geoffrey C. Schild","doi":"10.1016/0092-1157(89)90005-X","DOIUrl":"10.1016/0092-1157(89)90005-X","url":null,"abstract":"<div><p>A collaborative study was conducted to establish a suitable international reference reagent for hepatitis B vaccine for use in immunogenicity assays. The limiting dilution required to induce antibodies in 50% of the test animals was determined for the proposed international reference reagent and three other plasma-derived hepatitis B vaccines. The minimum antigenic dose of these preparations varied widely (100-fold range) between laboratories. However, the expression of potencies of vaccines relative to the proposed International Reference Reagent reduced the variation between laboratories to within a 10-fold range. The reference reagent is intended for use in assays of hepatitis B vaccines in mouse (or guinea-pig) immunogenicity studies. For products made by different procedures, clinical trials in humans are necessary to establish a correlation between the immunogenic potency in animals and man.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 151-160"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90005-X","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13668544","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":"Potency assay of antibodies against rabies. A report on a collaborative study","authors":"Jørn Lyng , M.Weis Bentzon , E.A. Fitzgerald","doi":"10.1016/0092-1157(89)90019-X","DOIUrl":"10.1016/0092-1157(89)90019-X","url":null,"abstract":"<div><p>The relative potencies of a number of rabies immunoglobulin preparations were estimated in an international collaborative study comprising eight laboratories in five countries. Two assay methods were used: a virus neutralization test in mice (MNT) and a virus neutralization test in cell culture (RFFIT). Differences between the results obtained by the two methods, which have been reported, could <em>not</em> be generally corroborated. The results indicate that in some laboratories the MNT cause difficulties and give results different from those obtained by RFFIT. In other laboratories such difficulties are not encountered. The results seem to indicate that the RFFIT is a more reliable method than the MNT.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 3","pages":"Pages 267-280"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90019-X","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13933321","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}
Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy
{"title":"Notes to applicants for marketing authorizations on the production and quality control of medicinal products derived by recombinant DNA technology","authors":"Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy","doi":"10.1016/0092-1157(89)90014-0","DOIUrl":"10.1016/0092-1157(89)90014-0","url":null,"abstract":"","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 3","pages":"Pages 223-231"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90014-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13933357","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. Sutton , P. Depledge , L. Bawden , A. Carne , M. Meltzer , V. Newton , L. Vodinelich
{"title":"Purification and sequencing of glycosylation variants of BSF-1, as a MAF, from the EL-4 leukaemia cell line","authors":"C. Sutton , P. Depledge , L. Bawden , A. Carne , M. Meltzer , V. Newton , L. Vodinelich","doi":"10.1016/0092-1157(89)90029-2","DOIUrl":"10.1016/0092-1157(89)90029-2","url":null,"abstract":"<div><p>Macrophage activation activity was characterized from a PMA-induced subclone of the murine EL-4 leukaemic cell line. The MAF was purified from the cell line culture supernatant by concentration, CM-Sepharose and lentil lectin Sepharose chromatography, AcA 54 gel filtration, Mono Q FPLC and reverse phase HPLC. Four protein bands of different abundance were observed on SDS-PAGE with molecular weights of 17 500 to 21 000 Da. Three of the four proteins were sequenced from the N-terminal and shared homology with the published sequence of BSF-1. Variation of the molecular weight due to glycosylation was demonstrated by N-glycanase treatment, all four proteins gave a band of 14 200 Da after deglycosylation. Both glycosylated and deglycosylated forms of BSF-1 were equally active in the MAF assay. A monoclonal antibody to BSF-1 neutralized 80% of the activity from crude culture supernatants in the MAF assay. These studies have indicated that BSF-1 is the major, if not the only, MAF activity from this particular subline of the murine EL-4 leukaemic cell line.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 1","pages":"Pages 65-70, IN3-IN4, 71-74"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90029-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13788556","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. Hendriksen , J.W. van der Gun , J.G. Kreeftenberg
{"title":"Combined estimation of tetanus and diphtheria antitoxin in human sera by the in vitro Toxin-Binding Inhibition (ToBI) test","authors":"C.F.M. Hendriksen , J.W. van der Gun , J.G. Kreeftenberg","doi":"10.1016/0092-1157(89)90009-7","DOIUrl":"10.1016/0092-1157(89)90009-7","url":null,"abstract":"<div><p>The use of the principle of inhibition of toxin binding to an antitoxin coated immunoassay plate as described in a previous paper for tetanus antitoxin titration, was adapted for the estimation of diphtheria antitoxin in human sera. With a few modifications, a Toxin-Binding Inhibition (ToBI) test was developed which could be used for a combined estimation of both tetanus and diphtheria antitoxin levels. The application of streptavidin-biotinylated peroxidase complex when using small serum samples (<50 μl) is discussed. Antitoxin titres (both diphtheria and tetanus) of 0·002 IU ml<sup>−1</sup> were detectable by the ToBI test, this being far below the level considered to be protective in man.</p><p>Sera from 140 adults with different vaccination histories were titrated for both tetanus and diphtheria antitoxin. Good correlations were found between the estimates obtained by the ToBI test and those obtained by the toxin-neutralization (TN) test in mice (tetanus antitoxin) and those obtained in the <em>in vitro</em> neutralization test in VERO cells (diphtheria antitoxin).</p><p>It is concluded that the ToBI test is a simple and reliable alternative to the functional models currently in use for the estimation of diphtheria and tetanus antitoxin levels. In addition, the ToBI test eliminates the need for laboratory-animal or cell-culture facilities and can be performed with small quantities of serum as required in field trials.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 191-200"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90009-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13855211","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 effect of cyclodextrin on lipopolysaccharide production in cultures of Bordetella pertussis","authors":"P. Ibsen , C. Schou , M. Au-Jensen , I. Heron","doi":"10.1016/S0092-1157(89)80003-4","DOIUrl":"10.1016/S0092-1157(89)80003-4","url":null,"abstract":"<div><p>The effect of adding 500 μg of (2,6-0-dimethyl) <em>β</em>-cydodexcrin (Me-<em>β</em>-CD) per ml of Stainer-Scholte (SS) medium in two-day shaker flask cultures of <em>Bordetella pertussis</em> on the production of lipopolysaccharide (LPS) was investigated. The amount of LPS per 10<sup>9</sup> cells found in the supernatants of these cultures was either somewhat reduced or unaffected by comparison with the amounts in cultures grown in SS-medium alone. In addition, the time course of LPS release from cultures of <em>B. pertussis</em> strain 3843 cells during a 96-h growth period in normal and Me-<em>β</em>-CD-enriched SS medium is described. By using the enriched medium bacterial growth, the production of filamentous haemagglutinin (FHA) and of pertussis toxin (Pt) and the levels of haemagglutination and lymphocytosis-promoting activity were enhanced to various degrees. Measurements made on sedimented whole and on sonicated <em>B. pertussis</em> cells grown in the two media showed no differences in LPS content.</p><p>The reasons for the reduced/unaffected LPS production are discussed. It has been suggested that an interaction between hydrophobic cavities of the Me-<em>β</em>-CD molecules and the ‘lipid A’ part of LPS reduces the reactivity of LPS in the <em>Limulus</em> Amoebocyte Lysate (LAL) assay. This possibility, however, was rejected as the reactivity of Me-<em>β</em>-CD-spiked purified <em>B. pertussis</em> strain 3803 LPS, compared with unspiked samples, remained unchanged.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 4","pages":"Pages 321-330"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(89)80003-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13703360","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}
Evgenia M. Dragunsky , Carole R. Wooden , Susan A. Vargo , Inessa S. Levenbook
{"title":"Salmonella typhi vaccine strain in vitro; low infectivity in human cell line U937","authors":"Evgenia M. Dragunsky , Carole R. Wooden , Susan A. Vargo , Inessa S. Levenbook","doi":"10.1016/S0092-1157(89)80006-X","DOIUrl":"10.1016/S0092-1157(89)80006-X","url":null,"abstract":"<div><p><em>Salmonella typhi</em> strain Ty21a has been used for live oral vaccine. The infectivity of Ty21a, in comparison with <em>S. typhi</em> Ty2, was evaluated using the human monocyte-macrophage cell line U937. Assays were performed by quantitative microscopy and viable count technique. Ty2 infected approximately 100% of the cells, multiplied extensively within these cells and caused cell death. The same dose of Ty21a infected only about 15% of the cells, resulting in a low number of intracellular bacilli and cell survival. The use of gentamicin in the test confirmed intracellular multiplication of Ty2 but not Ty21a. The system described may be suitable as a test system for characterization of the degree of virulence of Ty2 la and other live, oral typhoid vaccines.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 4","pages":"Pages 353-360, IN4"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(89)80006-X","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13754729","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}
J. Blancou , M.F.A. Aubert , Eveline Cain , Myriam Selve , O. Thraenhart , L. Bruckner
{"title":"Effect of strain differences on the potency testing of rabies vaccines in mice","authors":"J. Blancou , M.F.A. Aubert , Eveline Cain , Myriam Selve , O. Thraenhart , L. Bruckner","doi":"10.1016/0092-1157(89)90018-8","DOIUrl":"10.1016/0092-1157(89)90018-8","url":null,"abstract":"<div><p>Antigenic differences between several strains of rabies virus, namely CVS, SAD and Flury (LEP) strains, were studied in cross-challenge experiments or cross-neutralization tests performed on sera of mice immunized with vaccines containing each strain. A typical wild fox virus strain was also included as challenge virus. The strain differences affected the relative potencies of the three vaccines in the European Pharmacopoeia mouse protection test for veterinary rabies vaccines, in that higher antigenic values were obtained when the vaccine strain was homologous to the challenge virus. This observation was confirmed by neutralizing antibody induction in mice.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 3","pages":"Pages 259-266"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90018-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13933360","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}
Carla Cellesi , Clara Michelangeli , Gian Maria Rossolini , Franco Giovannoni , Aldo Rossolini
{"title":"Immunity to diphtheria, six to 15 years after a basic three-dose immunization schedule","authors":"Carla Cellesi , Clara Michelangeli , Gian Maria Rossolini , Franco Giovannoni , Aldo Rossolini","doi":"10.1016/0092-1157(89)90025-5","DOIUrl":"10.1016/0092-1157(89)90025-5","url":null,"abstract":"<div><p>The results of a study of the immunity to diphtheria of 283 girls (9–18 years of age) vaccinated at the age of two years with three doses of vaccine, are reported. The rabbit skin test was used to determine the titre of serum diphtheria antitoxin. 55·8% of the subjects were found to be protected (titre ≥ 0·1 IU/ml), 38·9% were only relatively immune (titre ≥ 0·01-< 0·1 IU/ml), and 5·3% were unprotected (titre < 0·01 IU/ml). The antitoxin titres showed a tendency to decrease with time. Even so, 6–15 years after vaccination, the percentages of protected and partially protected subjects were still high (95%).</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 1","pages":"Pages 29-34"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90025-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14058064","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}