Journal of biological standardization最新文献

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A procedure for total protein determination with special application to allergenic extract standardization 过敏原提取物标准化中总蛋白的测定方法
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90010-8
Paul G. Richman , David S. Cissel
{"title":"A procedure for total protein determination with special application to allergenic extract standardization","authors":"Paul G. Richman ,&nbsp;David S. Cissel","doi":"10.1016/0092-1157(88)90010-8","DOIUrl":"10.1016/0092-1157(88)90010-8","url":null,"abstract":"<div><p>A method for total protein determination of allergenic extracts has been developed and evaluated. Samples were hydrolyzed with 5 <span>m</span> NaOH followed by colorimetric determination with ninhydrin of the released amino acids using bovine serum albumin as the standard. The entire procedure was carried out in disposable plastic tubes. Substances (glycerol, phenol and mannitol) commonly present in allergenic extracts manufactured for human use did not affect the assay results. Analyses of four different pollen extracts by the method gave good agreement with amino acid analyses. Other methods of analysis (total N, protein N unit assay, Lowry) gave more variable results compared with amino acid analysis. Analysis of the total protein content of 53 different lots of allergenic extracts gave narrow ranges of values for each species. Standardized mite extracts analyzed for total protein by US FDA-licensed manufacturers using this assay showed a good correlation of biological activity with total protein.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 4","pages":"Pages 225-238"},"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)90010-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14328487","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: 16
The establishment and characterization of mouse L-929 cells in protein-free Eagle's Minimal Essential Medium 小鼠L-929细胞在无蛋白Eagle’s Minimal Essential培养基中的建立与表征
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90012-1
J. Cinatl Jr. , J. Cinatl , V. Gerein , B. Kornhuber , H.W. Doerr
{"title":"The establishment and characterization of mouse L-929 cells in protein-free Eagle's Minimal Essential Medium","authors":"J. Cinatl Jr. ,&nbsp;J. Cinatl ,&nbsp;V. Gerein ,&nbsp;B. Kornhuber ,&nbsp;H.W. Doerr","doi":"10.1016/0092-1157(88)90012-1","DOIUrl":"10.1016/0092-1157(88)90012-1","url":null,"abstract":"<div><p>The mouse cell line L-929 was established in protein-free Eagle's Minimal Essential Medium. The cells have been ‘adapted’ to continuous growth in the medium using stepwise reductions in the concentration of fetal bovine serum. The cells designated L-929-WS have now been propagated in protein-free Eagle's Minimal Essential Medium for two years. The population-doubling time was about 37 h. The addition of serum stimulated cell growth only slightly, but the saturation density was significantly increased. Morphological examination, a study of the secretion of colony stimulating activity and cytochemical investigations for acid phosphatase and alkaline phosphatase showed that L-929-WS cells, grown in protein-free Eagle's Minimal Essential Medium, did not differ markedly from cells propagated in medium containing serum. The cells provided a simple model for the study of cell growth in the absence of serum or the other macromolecular substances usually added to cell cultures. The general application of the cells for purposes in which the addition of serum or growth factors might interfere, is suggested.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 4","pages":"Pages 249-252, IN1-IN2, 253-257"},"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)90012-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14190623","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: 5
Characterization of Vero cells Vero细胞的表征
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90019-4
Stephen K. Swanson , Steven J. Mento , Carolyn Weeks-Levy , Bonnie D. Brock , Kieron J. Kowal , Rosalyn E. Wallace , Mary B. Ritchey , Francis R. Cano
{"title":"Characterization of Vero cells","authors":"Stephen K. Swanson ,&nbsp;Steven J. Mento ,&nbsp;Carolyn Weeks-Levy ,&nbsp;Bonnie D. Brock ,&nbsp;Kieron J. Kowal ,&nbsp;Rosalyn E. Wallace ,&nbsp;Mary B. Ritchey ,&nbsp;Francis R. Cano","doi":"10.1016/0092-1157(88)90019-4","DOIUrl":"10.1016/0092-1157(88)90019-4","url":null,"abstract":"<div><p>A cell line used in the production of biologicals should be free of infectious agents, and ‘described with respect to cytogenetic characteristics and tumorigenicity’. Vero, a continuous cell line derived from a normal African green monkey kidney, was examined for the presence of retroviruses and for tumorigenic potential. We were unable to detect the presence of retroviruses by reverse transcriptase assay, electron microscopy or hybridization of cellular genomic DNA with Mason-Pfizer monkey virus DNA probes. In addition, passage 156 Vero cells did not form progressively growing tumors in nude mice or grow with high efficiency in soft agarose.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 4","pages":"Pages 311-318, IN7-IN8, 319-320"},"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)90019-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14328491","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: 16
Experience in Canada with the new revised monkey neurovirulence test for oral poliovirus vaccine 加拿大新修订的口服脊髓灰质炎病毒疫苗猴神经毒力试验的经验
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90007-8
G. Contreras , J. Furesz , K. Karpinski , K. Grinwich , C. Gardell
{"title":"Experience in Canada with the new revised monkey neurovirulence test for oral poliovirus vaccine","authors":"G. Contreras ,&nbsp;J. Furesz ,&nbsp;K. Karpinski ,&nbsp;K. Grinwich ,&nbsp;C. Gardell","doi":"10.1016/0092-1157(88)90007-8","DOIUrl":"10.1016/0092-1157(88)90007-8","url":null,"abstract":"<div><p>Nine years of experience in our laboratory, using more than 1500 cynomolgus monkeys in 138 tests, has shown that the new neurovirulence test (NVT) adopted by the World Health Organization (WHO) for live, oral monovalent vaccine of each poliovirus type, was a reproducible and sensitive assay likely to ensure the safety of this vaccine in humans. Our findings were the following: (1) when the test vaccine and the appropriate homotypic reference vaccine were tested in a single group of monkeys, the concurrent use of the reference vaccine considerably increased the reproducibility of the NVT; (2) in the assessment of the degree of attenuation of each lot of vaccine, the use of 12 monkeys for types 1 and 2 vaccines and 20 monkeys for type 3 vaccine (inoculated intraspinally each for reference and test vaccine) was satisfactory; (3) the virus dose used per monkey (10<sup>5.6</sup> to 10<sup>6.6</sup> pfu per monkey) was found not to be critical, i.e. the lower virus dose yielded mean lesion scores in the central nervous system of monkeys at least as high or higher than the tenfold higher virus dose; (4) the statistical analysis of our data showed that the old intrathalamic (IT) assay was considerably less sensitive than the new intraspinal (IS) assay, i.e., a test vaccine with a twofold increase in monkey neurovirulence would have a 41% chance of failing in the IT test (using 30 monkeys per vaccine), while this chance increased to 99% in the WHO IS assay (using 12 or 20 monkeys per vaccine). Since the introduction of the WHO NVT in Canada, the laboratory findings in monkeys were confirmed by vaccine experience in humans; the number of vaccine-associated paralytic poliomyelitis cases in the population showed a further decline.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 3","pages":"Pages 195-205"},"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)90007-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13981793","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: 11
Additives to biological substances V—The stability of lactose as a carrier for biological standards 生物物质添加剂——乳糖作为生物载体的稳定性标准
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90030-3
D.H. Calam , E. Tarelli
{"title":"Additives to biological substances V—The stability of lactose as a carrier for biological standards","authors":"D.H. Calam ,&nbsp;E. Tarelli","doi":"10.1016/0092-1157(88)90030-3","DOIUrl":"10.1016/0092-1157(88)90030-3","url":null,"abstract":"<div><p>The stability of freeze-dried lactose has been studied, by accelerated degradation, after being ampouled under the conditions employed for the preparation of International Standards and Reference Preparations and also under less stringent conditions which might facilitate degradation. The possible formation of the reactive product, 5-hydroxymethyl-furfural, has been monitored over a period of 10 years at temperatures up to 56°C. No evidence has been obtained to suggest that the formation of this compound would present a hazard to the stability of standards prepared by the procedures customarily employed.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 1","pages":"Pages 63-66"},"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)90030-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14477782","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: 2
The preparation of international reference materials for biological substances 生物物质国际标准品的制备
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90040-6
Philippe Sizaret
{"title":"The preparation of international reference materials for biological substances","authors":"Philippe Sizaret","doi":"10.1016/0092-1157(88)90040-6","DOIUrl":"10.1016/0092-1157(88)90040-6","url":null,"abstract":"","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 2","pages":"Pages 129-137"},"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)90040-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14498136","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: 3
The determination of low levels of aluminum in antihemophilic factor (human) preparations by flame atomic absorption spectrometry 火焰原子吸收光谱法测定抗血友病因子(人)制剂中低含量铝
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90039-X
Joseph J. Progar , Joan C. May
{"title":"The determination of low levels of aluminum in antihemophilic factor (human) preparations by flame atomic absorption spectrometry","authors":"Joseph J. Progar ,&nbsp;Joan C. May","doi":"10.1016/0092-1157(88)90039-X","DOIUrl":"10.1016/0092-1157(88)90039-X","url":null,"abstract":"<div><p>Aluminum hydroxide is used to adsorb extraneous protein during the preparation of Antihemophilic Factor (Human) (AHF). Removal of Al(OH)<sub>3</sub> is accomplished by centrifugation and filtration. This study describes a method for the determination of residual aluminum in AHF by flame atomic absorption spectrometry. Matrix interferences were minimized by employing sample digestion with HNO<sub>3</sub> prior to nebulization in a nitrous oxide-acetylene flame. Under these conditions, the limit of detection of aluminum in an aqueous system was estimated to be approximately 0·13 μg Al ml<sup>−1</sup>, while the limit of quantitation was estimated to be approximately 0·56 μg Al ml<sup>−1</sup>. Residual aluminum levels in AHF determined by this method ranged from &lt;0·20 μg ml<sup>−1</sup> to 0·82 μg ml<sup>−1</sup>. Butyl alcohol was used to modify sample matrices after digestion to increase the sensitivity of the assay system. An increase in the aluminum absorption signal was demonstrated after the addition of butyl alcohol to an AHF digest.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 2","pages":"Pages 119-127"},"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)90039-X","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14262425","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: 5
Acellular pertussis vaccines: evaluation of reversion in a nude mouse model 无细胞百日咳疫苗:在裸鼠模型中的逆转评价
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90037-6
M.J. Quentin-Millet , F. Arminjon , B. Danve , M. Cadoz , J. Armand
{"title":"Acellular pertussis vaccines: evaluation of reversion in a nude mouse model","authors":"M.J. Quentin-Millet ,&nbsp;F. Arminjon ,&nbsp;B. Danve ,&nbsp;M. Cadoz ,&nbsp;J. Armand","doi":"10.1016/0092-1157(88)90037-6","DOIUrl":"10.1016/0092-1157(88)90037-6","url":null,"abstract":"<div><p>An animal model has been developed to assess the safety of acellular pertussis vaccines in terms of reversion to toxicity. Adsorbed pertussis toxoid preparations, alone or combined in a DTP formulation, were administered to nude mice intraperitoneally. In parallel, groups of positive and negative control mice received pertussis toxin and buffer, respectively. The circulating white blood cells of the animals were monitored for 28 days. Mice immunized with glutaraldehyde toxoid preparations did not develop a lymphocytosis during the observation period, wheteas mice immunized with an experimental formalin pertussis toxoid vaccine exhibited a high lymphocytosis six days after vaccine administration, demonstrating, in this model, a reversion of the toxoid. The nude mouse model thus appears to reveal the <em>in-vivo</em> reversion of pertussis toxoids and could be included in the quality control panel for the assessment of the safety of acellular pertussis vaccine.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 2","pages":"Pages 99-108"},"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)90037-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14388684","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: 28
A novel Candida albicans skin test antigen: efficacy and safety in man 一种新的白色念珠菌皮肤试验抗原:在人体内的有效性和安全性
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90027-3
Robert E. Esch , C.Edward Buckley III
{"title":"A novel Candida albicans skin test antigen: efficacy and safety in man","authors":"Robert E. Esch ,&nbsp;C.Edward Buckley III","doi":"10.1016/0092-1157(88)90027-3","DOIUrl":"10.1016/0092-1157(88)90027-3","url":null,"abstract":"<div><p>Yeast phase <em>Candida albicans</em> (ATCC No. 10231) was grown in a nonantigenic medium, harvested and lyophilized. Ammonium sulfate fractions of an aqueous extract of the lyophilized cells were evaluated and the fraction yielding the highest specific delayed cutaneous reactivity in sensitized guinea-pigs was used to prepare a <em>C. albicans</em> skin test antigen (CASTA). The safety of the antigen was evaluated by measuring immediate and delayed (0·25, 6, 24, 48 and 72 h) cutaneous reactions in atopic and nonatopic human subjects. The outcome of three repetitive monthly Mantoux skin tests with 0·01-1 μg antigen doses was used to test for booster effects in 14 subjects and to estimate a safe initial test antigen dose. The utility of a single skin test as a measure of cell-mediated immunity was evaluated in 40 healthy subjects. Reactor rates (≥2 mm, 48 h) of 40% and 85% were detected, respectively, with doses of 0·0316 and 1 μg. Using a skin test reaction diameter ≥5 mm at 48 h, the reactor rate was 50% for the 1-μg dose. The only adverse reaction (45 mm, 0·25 h) was detected with the 1-μg dose in an atopic subject who also exhibited exquisite scratch test reaginic hypersensitivity to <em>C. albicans</em> allergen. The prevalence of other adverse reactions to this antigen compared favorably with that to other antigens used for recall antigen testing. These studies suggest the 1-μg CASTA dose can be used for effective, safe recall antigen skin tests.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 1","pages":"Pages 33-43"},"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)90027-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14409625","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: 13
The preparation of cultured rabies virus and the production of antiserum for human use 人用狂犬病毒培养的制备及抗血清的制备
Journal of biological standardization Pub Date : 1988-01-01 DOI: 10.1016/0092-1157(88)90026-1
C.A. Consales , E.J.G. Valentini , A. Albas , R.M.Z. Mendonca , R.M.M. Fuches , M.A. Soares , C.A. Pereira
{"title":"The preparation of cultured rabies virus and the production of antiserum for human use","authors":"C.A. Consales ,&nbsp;E.J.G. Valentini ,&nbsp;A. Albas ,&nbsp;R.M.Z. Mendonca ,&nbsp;R.M.M. Fuches ,&nbsp;M.A. Soares ,&nbsp;C.A. Pereira","doi":"10.1016/0092-1157(88)90026-1","DOIUrl":"10.1016/0092-1157(88)90026-1","url":null,"abstract":"<div><p>In this paper we describe a methodology for the preparation of the Pasteur strain of fixed rabies virus in BHK-21 clone 13 cells and also its use for the production of antisera in horses. The methodology showed here is simple, rapid, facilitates the attainment of high protective titers, and the antisera produced are of high quality.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 1","pages":"Pages 27-32"},"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)90026-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14477781","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: 17
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