OPEN ACCESS ARTICLE www.bioprocessingjournal.com 1 FOOTNOTES 1. Footnotes 2–5 provide examples of the complexity of importation requirements. Additional requirements exist for other importing countries with respect to certain exporting regions, and this table should not be regarded as complete or necessarily current. Exporters should contact the relevant border inspection post to confirm current importation requirements. 2. Must come from a registered facility and meet importation eligibility requirements for sterility. Must be negative for mycoplasma, bluetongue virus, bovine viral diarrhea virus, bovine leukemia virus, cytopathic effect, and hemadsorption. 3. Requires three-month residency. 4. USDA Safety Testing – bluetongue and Akabane virus (must be negative after testing). 5. USDA Safety Testing – bluetongue virus (must be negative after testing). 6. Excluding Guatemala, El Salvador, and Belize. Introduction It is a common belief that fetal bovine serum (FBS) collected from certain geographical regions, such as New Zealand, is of superior quality to material collected from South America. Whilst it is true that origin does have an impact on the price of serum, it does not affect the quality or biological performance of the product. FBS collected under similar conditions from any geographical region will demonstrate comparable ability to support cell growth. For FBS, the term “quality” is frequently confused with “health status.” It is the health status of the geographical region from which the serum is collected that will dictate its potential use, the availability of material for import, and eventually, the price. It should be noted that health status should be considered a result of more than just the geographical source of the material, but also the regulatory infrastructure and how well regulations are enforced by the countries within that region. The health status of a country is determined by the World Organization for Animal Health (OIE). The mission of the OIE is to ensure transparency in the global animal disease situation. The OIE issues information concerning the health status of various countries with regard to animal diseases of concern, including foot-and-mouth disease, bovine spongiform encephalopathy (BSE), and other diseases affecting cattle populations globally.[1] The status of a country, with regard to the presence of an animal disease of concern, together with interagency government agreements, will determine where serum collected within that country may be exported. Individual countries have varying requirements for importation of serum from the same geographies based on the animal health status of the region from which the serum was collected. Table 1 provides an overview of the requirements for moving FBS from one part of the world to another. As can be seen, these requirements are extremely complex and are continually changing as regulations evolve. Exporters are strongly encouraged to contact border Fetal Bovine Ser
{"title":"Fetal Bovine Serum – Geographical Origin and International Trade","authors":"Jennifer Murray, R. Versteegen","doi":"10.12665/j18oa.murray","DOIUrl":"https://doi.org/10.12665/j18oa.murray","url":null,"abstract":"OPEN ACCESS ARTICLE www.bioprocessingjournal.com 1 FOOTNOTES 1. Footnotes 2–5 provide examples of the complexity of importation requirements. Additional requirements exist for other importing countries with respect to certain exporting regions, and this table should not be regarded as complete or necessarily current. Exporters should contact the relevant border inspection post to confirm current importation requirements. 2. Must come from a registered facility and meet importation eligibility requirements for sterility. Must be negative for mycoplasma, bluetongue virus, bovine viral diarrhea virus, bovine leukemia virus, cytopathic effect, and hemadsorption. 3. Requires three-month residency. 4. USDA Safety Testing – bluetongue and Akabane virus (must be negative after testing). 5. USDA Safety Testing – bluetongue virus (must be negative after testing). 6. Excluding Guatemala, El Salvador, and Belize. Introduction It is a common belief that fetal bovine serum (FBS) collected from certain geographical regions, such as New Zealand, is of superior quality to material collected from South America. Whilst it is true that origin does have an impact on the price of serum, it does not affect the quality or biological performance of the product. FBS collected under similar conditions from any geographical region will demonstrate comparable ability to support cell growth. For FBS, the term “quality” is frequently confused with “health status.” It is the health status of the geographical region from which the serum is collected that will dictate its potential use, the availability of material for import, and eventually, the price. It should be noted that health status should be considered a result of more than just the geographical source of the material, but also the regulatory infrastructure and how well regulations are enforced by the countries within that region. The health status of a country is determined by the World Organization for Animal Health (OIE). The mission of the OIE is to ensure transparency in the global animal disease situation. The OIE issues information concerning the health status of various countries with regard to animal diseases of concern, including foot-and-mouth disease, bovine spongiform encephalopathy (BSE), and other diseases affecting cattle populations globally.[1] The status of a country, with regard to the presence of an animal disease of concern, together with interagency government agreements, will determine where serum collected within that country may be exported. Individual countries have varying requirements for importation of serum from the same geographies based on the animal health status of the region from which the serum was collected. Table 1 provides an overview of the requirements for moving FBS from one part of the world to another. As can be seen, these requirements are extremely complex and are continually changing as regulations evolve. Exporters are strongly encouraged to contact border Fetal Bovine Ser","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44488003","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}
Pub Date : 2019-08-28DOI: 10.12665/j18oa.hawkes.0819
P. Hawkes, O. B. Nielsen, M. Wintgens
{"title":"Fetal Bovine Serum – Country of Origin, Geographic Relevance, and Labeling","authors":"P. Hawkes, O. B. Nielsen, M. Wintgens","doi":"10.12665/j18oa.hawkes.0819","DOIUrl":"https://doi.org/10.12665/j18oa.hawkes.0819","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41335619","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}
Pub Date : 2019-05-15DOI: 10.12665/J18OA.VERSTEEGEN
R. Versteegen, Kate Linterman, S. Lind, O. Shatova
{"title":"Testing for Geographic Origin of Fetal Bovine Serum","authors":"R. Versteegen, Kate Linterman, S. Lind, O. Shatova","doi":"10.12665/J18OA.VERSTEEGEN","DOIUrl":"https://doi.org/10.12665/J18OA.VERSTEEGEN","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44932532","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}
Lídia Garcia, M. Mouriño, A. Urniza, Sandra Juanola
{"title":"Evaluation of a Single-Use Benchtop Process Development System to Optimize Cell Growth and Scale-Up of Veterinary Vaccine Production","authors":"Lídia Garcia, M. Mouriño, A. Urniza, Sandra Juanola","doi":"10.12665/J18OA.GARCIA","DOIUrl":"https://doi.org/10.12665/J18OA.GARCIA","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49430636","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}
Greg Hanson, B. Croonenborghs, Mara Senescu, H. Hughes, R. Nims, R. Versteegen
{"title":"Gamma Irradiation of Animal Serum: General Regulatory Environment and Process Controls","authors":"Greg Hanson, B. Croonenborghs, Mara Senescu, H. Hughes, R. Nims, R. Versteegen","doi":"10.12665/j18oa.hanson","DOIUrl":"https://doi.org/10.12665/j18oa.hanson","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46151801","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}
Pub Date : 2019-01-28DOI: 10.12665/j18oa.hemmerich
Karl Hemmerich, R. Versteegen, R. Nims, Dennis Hallett, Randy R Fitzgerald
{"title":"Gamma Irradiation of Animal Serum: Theoretical Basis of Impacts of Gamma Irradiation on Biological and Synthetic Polymers","authors":"Karl Hemmerich, R. Versteegen, R. Nims, Dennis Hallett, Randy R Fitzgerald","doi":"10.12665/j18oa.hemmerich","DOIUrl":"https://doi.org/10.12665/j18oa.hemmerich","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42764706","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":"Fetal Bovine Serum and the Slaughter of Pregnant Cows: Animal Welfare and Ethics","authors":"O. B. Nielsen, Biowest, P. Hawkes","doi":"10.12665/J18OA.HAWKES","DOIUrl":"https://doi.org/10.12665/J18OA.HAWKES","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41516264","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":"Deploying Automated Buffer Production for cGMP Use: Points to Consider","authors":"A. Tsai, E. Carredano, Karolina Busson","doi":"10.12665/J18OA-TSAI","DOIUrl":"https://doi.org/10.12665/J18OA-TSAI","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46398864","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}
T. Talarico, M. Murphy, R. Nims, D. Hastings, J. Boose, Dave Dumers
M edicago manufactures influenza vaccine virus-like particles (VLPs) in an unusual production platform consisting of Nicotiana benthamiana plants. During the in vitro adventitious agent test (AAT) of certain Medicago B strain influenza vaccine VLP test samples, positive hemagglutination of guinea pig red blood cells was observed on day 14, but not on day 28. The positive result in the assay was surprising because the production process uses no animal-derived raw materials and contains a viral inactivation step. Plant-associated viruses would not be expected to infect the mammalian cell-based assay. No cytopathic effects or hemadsorption of red blood cells was observed in these AATs. The positive hemagglutination was observed at 2–8°C, but not at 36–38 °C, and only in a few of the six detector cell lines used in the assay. Because this is quite an unusual pattern of responses for an AAT, Medicago and the contract testing lab, Eurofins Lancaster Laboratories (ELLI) investigated the positive responses thoroughly for the presence of an adventitious agent or an alternative explanation not involving a viral contaminant. Investigation results indicated that the hemagglutinating activity associated with the vaccine test sample itself was responsible for the positive hemagglutination response. The positive hemagglutination on day 14 of these AATs was deemed an assay artifact, and preventive actions were taken to prevent recurrence of this type of false positive response.
M dicago在一个由烟叶植物组成的不寻常的生产平台上生产流感疫苗病毒样颗粒(VLPs)。某些Medicago B株流感疫苗VLP试验样品的体外不定剂试验(AAT)在第14天观察到豚鼠红细胞血凝反应阳性，但在第28天未观察到。试验的阳性结果令人惊讶，因为生产过程不使用动物来源的原料，并且包含病毒灭活步骤。植物相关病毒预计不会感染基于哺乳动物细胞的试验。在这些AATs中未观察到细胞病变作用或红细胞吸附。在2-8°C时观察到阳性血凝，但在36-38°C时未观察到阳性血凝，并且仅在试验中使用的六种检测细胞系中的少数细胞系中观察到阳性血凝。由于对于AAT、Medicago和合同测试实验室来说，这是一种非常不寻常的反应模式，因此Eurofins兰开斯特实验室(ELLI)彻底调查了阳性反应，以确定是否存在未知因子或不涉及病毒污染物的替代解释。调查结果表明，与疫苗试验样品本身相关的血凝活性是导致血凝反应阳性的原因。这些AATs第14天的血凝阳性被认为是检测伪产物，并采取预防措施防止这种类型的假阳性反应再次发生。
{"title":"Investigation of an Adventitious Agent Test False Positive Signal in a Plant-Derived Influenza Vaccine","authors":"T. Talarico, M. Murphy, R. Nims, D. Hastings, J. Boose, Dave Dumers","doi":"10.12665/J17OA.TALARICO","DOIUrl":"https://doi.org/10.12665/J17OA.TALARICO","url":null,"abstract":"M edicago manufactures influenza vaccine virus-like particles (VLPs) in an unusual production platform consisting of Nicotiana benthamiana plants. During the in vitro adventitious agent test (AAT) of certain Medicago B strain influenza vaccine VLP test samples, positive hemagglutination of guinea pig red blood cells was observed on day 14, but not on day 28. The positive result in the assay was surprising because the production process uses no animal-derived raw materials and contains a viral inactivation step. Plant-associated viruses would not be expected to infect the mammalian cell-based assay. No cytopathic effects or hemadsorption of red blood cells was observed in these AATs. The positive hemagglutination was observed at 2–8°C, but not at 36–38 °C, and only in a few of the six detector cell lines used in the assay. Because this is quite an unusual pattern of responses for an AAT, Medicago and the contract testing lab, Eurofins Lancaster Laboratories (ELLI) investigated the positive responses thoroughly for the presence of an adventitious agent or an alternative explanation not involving a viral contaminant. Investigation results indicated that the hemagglutinating activity associated with the vaccine test sample itself was responsible for the positive hemagglutination response. The positive hemagglutination on day 14 of these AATs was deemed an assay artifact, and preventive actions were taken to prevent recurrence of this type of false positive response.","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44330284","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}
S. Pincus, C. Sadowski, Emigdio D. Reyes, J. Madsen
{"title":"A Suspension Vero Cell Line for Production of Viral Vaccines and Viral Therapeutics","authors":"S. Pincus, C. Sadowski, Emigdio D. Reyes, J. Madsen","doi":"10.12665/J17OA.PINCUS","DOIUrl":"https://doi.org/10.12665/J17OA.PINCUS","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49439171","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}
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