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Membrane-based cell culture systems--an alternative to in vivo production of monoclonal antibodies. 基于膜的细胞培养系统——单克隆抗体在体内生产的替代方案。
Developments in biological standardization Pub Date : 1999-01-01
A Nagel, S Koch, U Valley, F Emmrich, U Marx
{"title":"Membrane-based cell culture systems--an alternative to in vivo production of monoclonal antibodies.","authors":"A Nagel,&nbsp;S Koch,&nbsp;U Valley,&nbsp;F Emmrich,&nbsp;U Marx","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A new generation of membrane-based cell culture devices especially designed for small scale production of monoclonal antibodies (mabs) has entered the market in the last few years. In contrast to conventional perfusion hollow fibre bioreactors, these devices contain two functionally different membranes--one ultrafiltration membrane for nutrient supply and one gas-permeable membrane for direct oxygenation of cells. The latest systems of this generation are static culture systems which are of moderate cost and either better than, or equal to, the ascites mice in terms of quality and quantity of produced monoclonal antibodies. We have investigated the advantages of the perfused Tecnomouse bioreactor and the static CELLine culture flasks in comparison to ascites production and conventional roller bottle cultures.</p>","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"57-64"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21425041","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
Developments in the reduction refinement and replacement of animal tests in the quality control of immunobiologicals. 免疫生物制剂质量控制中减少、改进和替代动物试验的进展。
Developments in biological standardization Pub Date : 1999-01-01
J G Kreeftenberg
{"title":"Developments in the reduction refinement and replacement of animal tests in the quality control of immunobiologicals.","authors":"J G Kreeftenberg","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"13-7"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21425771","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
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
{"title":"A comparison of physico-chemical and biological assays in the batch release of therapeutic cytokines.","authors":"A F Bristow","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"97 ","pages":"81-7"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21327220","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
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
{"title":"The role of Pharmacopoeia standards and monographs.","authors":"A Artiges","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"97 ","pages":"177-81"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21327705","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
Production of influenza virus in serum-free mammalian cell cultures. 无血清哺乳动物细胞培养中流感病毒的产生。
Developments in biological standardization Pub Date : 1999-01-01
O W Merten, J C Manuguerra, C Hannoun, S van der Werf
{"title":"Production of influenza virus in serum-free mammalian cell cultures.","authors":"O W Merten,&nbsp;J C Manuguerra,&nbsp;C Hannoun,&nbsp;S van der Werf","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Human influenza viruses are routinely isolated and grown in a variety of mammalian cell substrates. However, influenza viruses for use as inactivated vaccine are still produced in embryonated eggs. Using a perfusion culture-based bioreactor process using serum-free medium, both human and equine influenza viruses of different types and subtypes could be produced to high titres. Classical DEAE-dextran microcarriers were found to be more suitable than polyester sponge carriers for virus production. In addition, MDCK cells grown in serum-free medium were further validated as the most suitable cell substrate compared to Vero and BHK-21 C13 cells for large scale virus production of influenza virus. Finally, to minimize potential contamination by adventitious agents, it was demonstrated that a new serum-free medium in which all animal-derived products are replaced by a plant extract, efficiently supports the growth of MDCK cells as well as the production of influenza virus in the presence of trypsin when using the perfusion bioreactor process.</p>","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"98 ","pages":"23-37; discussion 73-4"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21357769","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
Cell culture for surveillance on influenza. 流感监测的细胞培养。
Developments in biological standardization Pub Date : 1999-01-01
M Zambon
{"title":"Cell culture for surveillance on influenza.","authors":"M Zambon","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"98 ","pages":"65-71; discussion 73-4"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21357771","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
Evaluation of immune responses to inactivated influenza vaccines prepared in embryonated chicken eggs and MDCK cells in a mouse model. 在小鼠模型中评价用鸡胚蛋和MDCK细胞制备的灭活流感疫苗的免疫应答。
Developments in biological standardization Pub Date : 1999-01-01
K Nerome, H Kumihashi, R Nerome, Y Hiromoto, Y Yokota, R Ueda, K Omoe, M Chiba
{"title":"Evaluation of immune responses to inactivated influenza vaccines prepared in embryonated chicken eggs and MDCK cells in a mouse model.","authors":"K Nerome,&nbsp;H Kumihashi,&nbsp;R Nerome,&nbsp;Y Hiromoto,&nbsp;Y Yokota,&nbsp;R Ueda,&nbsp;K Omoe,&nbsp;M Chiba","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This study was initiated with the isolation of influenza A and B viruses from clinical throat swabs in both fertile chicken eggs (egg) and MDCK cells, which were used in subsequent vaccine production in the above two hosts. On the basis of haemagglutination-inhibiting (HI) tests, immune mouse sera from mice vaccinated with MDCK cell-derived vaccines revealed antigenic similarities among H3N2 or B viruses isolated in MDCK cells or eggs. Similarly, antiserum prepared by immunization with egg-derived H3N2 vaccine showed equivalent antigenicity between homologous and heterologous (MDCK cell-derived) viruses. In contrast, antigenicity of egg-derived B vaccines was differed somewhat from that of MDCK cell-derived vaccines, suggesting the occurrence of antigenic change due to passaging in eggs. The time-course of immune responses based on HI titres indicated that MDCK cell-derived vaccines elicited extremely high antibody levels. Also, it was evident that antibody production by MDCK cell-grown H3N2 vaccine was very similar to that of vaccine prepared from egg-grown viruses. These results were comparable to those of plaque neutralization tests, although antigenic differences between egg- and MDCK cell-derived challenge viruses were confirmed in the test with antiserum to MDCK cell-derived vaccine. Consistent with HI-antibody production, the immunogenicity of MDCK cell-derived B vaccine appeared to be low by plaque neutralization test, while immune responses in mice which received egg-derived vaccines were significantly higher than that of the former. Furthermore, immune responses confirmed in mice immunized with B virus vaccines prepared in eggs revealed slight antigenic differences between two viruses derived from their respective hosts. Nevertheless, through evaluation of immune responses, MDCK cell-derived influenza vaccines may be useful when weak immunogenicity of B virus vaccine is improved.</p>","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"98 ","pages":"53-63; discussion 73-4"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21357772","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
Neurovirulence. 神经毒性。
Developments in biological standardization Pub Date : 1999-01-01
D Wood
{"title":"Neurovirulence.","authors":"D Wood","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Alternatives to the standard WHO neurovirulence test (nvt) in simians for live attenuated poliovirus vaccines are highly developed, at least for poliovirus type 3. The alternatives are MAPREC, a molecular biological assay, and transgenic mice that express the human cellular receptor for polioviruses (TgPVR mice). The MAPREC assay quantifies reversion of key mutations that may accumulate during vaccine manufacture. Collaborative studies organised by WHO showed that the assay is sensitive, robust and standardised. WHO International Standard and Reference Reagents are established. Samples that fail the MAPREC assay need not be tested for neurovirulence in monkeys. The assay is now being used by both manufacturers and national control laboratories to characterise virus seeds and to monitor the consistency of production at the molecular level. A regulatory decision-making model has also been developed in the TgPVR21 mouse line. The model has been found a valuable indicator of neurovirulence in a WHO collaborative study. These alternative methods are the fruits of a long-term basic research programme on the molecular biology of polioviruses and provide an excellent example of co-ordinated regulatory research.</p>","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"127-9"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21424989","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
Synthetic peptide vaccines: foot-and-mouth disease virus as a model. 合成肽类疫苗:以口蹄疫病毒为模型。
Developments in biological standardization Pub Date : 1999-01-01
F Sobrino, E Blanco, M García-Briones, V Ley
{"title":"Synthetic peptide vaccines: foot-and-mouth disease virus as a model.","authors":"F Sobrino,&nbsp;E Blanco,&nbsp;M García-Briones,&nbsp;V Ley","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Foot-and-mouth disease virus (FMDV) has been one of the pioneering viral systems in the development of synthetic peptides as vaccines. Protection against FMDV infection is associated with the induction of neutralising antibodies. Therefore, attempts have been made to identify peptides capable of eliciting protective humoral responses. Peptides based on a continuous, immunodominant B cell site on the capsid protein VP1 have been shown to confer limited protection in natural hosts. This probably reflects the difficulties in reproducing the immunogenicity of an entire viral particle by using a much simpler synthetic antigen, due to: (i) the polymorphism of the class II MHC; (ii) the adequate presentation to the immune system of the peptides, and (iii) the difficulties of achieving protection against a highly variable RNA virus, which may favour selection of virus antigenic variants. The improvement of FMD peptide vaccines, and the development of in vitro alternatives to in vivo immunogenic assays require further understanding of the immune mechanisms leading to protection against this important animal virus disease.</p>","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"101 ","pages":"39-43"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21425038","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
Challenges for biological standardization and control in the 21st century. 21世纪生物标准化与控制面临的挑战。
Developments in biological standardization Pub Date : 1999-01-01
K C Zoon
{"title":"Challenges for biological standardization and control in the 21st century.","authors":"K C Zoon","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"100 ","pages":"95-9"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21471758","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
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