Pub Date : 2018-09-05DOI: 10.12665/J17OA.WITCHER.0905
Mark Witcher
{"title":"ICH Q12 Should Build on the ICH Q8 Design Space","authors":"Mark Witcher","doi":"10.12665/J17OA.WITCHER.0905","DOIUrl":"https://doi.org/10.12665/J17OA.WITCHER.0905","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42350594","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}
R. Valdés, U. Černigoj, Eduardo Sánchez, Daily Hernández, Blass Nemec, M. Limonta, Miguel Castillo, B. Pérez, U. Vidic, J. Vidič, M. Žorž, A. Tamayo, L. Gómez, W. Ferro, Yurisleydi Aldama, N. Krajnc, D. Marc, A. Štrancar
{"title":"Hepatitis B Surface Antigen Particle Purification by Immunoaffinity Chromatography Based on CDI-CB.Hep-1 mAb Monolithic Supports","authors":"R. Valdés, U. Černigoj, Eduardo Sánchez, Daily Hernández, Blass Nemec, M. Limonta, Miguel Castillo, B. Pérez, U. Vidic, J. Vidič, M. Žorž, A. Tamayo, L. Gómez, W. Ferro, Yurisleydi Aldama, N. Krajnc, D. Marc, A. Štrancar","doi":"10.12665/J17OA.VALDES","DOIUrl":"https://doi.org/10.12665/J17OA.VALDES","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45928791","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}
Growth performance testing in cell culture is an effective approach to making serum suitability and purchase decisions.[1] An independent commercial testing lab conducted two separate and sequential growth promotion studies to underscore the need for pre-purchase lot performance testing with: (1) FBS; and (2) FBS alternatives. Results from both studies are presented here to compare and contrast: • FBS lots to each other • FBS alternatives lots to each other • FBS alternatives lots to FBS FBS alternatives are included because they are often overlooked as a cost-effective substitute for FBS, providing, in many cases, equivalent performance. It is advisable to avoid preconceived notions con cern ing the quality or performance of a serum product without considering the culture system, culture con ditions, and the subject cells, which can all have a material impact on its performance in cell culture. Test – then decide. 1. FBS Performance Challenge Test article (TA) lot performance was evaluated with three different cell lines at four TA concentrations. Additionally, the impact of TA concentration used in the cell culture medium was examined. FBS end-users employ various methods for assessing TABLE 1. Test article key, FBS performance challenge. TA # Supplier Description Catalog # Lot # 1 VWR Seradigm FBS 89510-194 013B16 2 VWR Seradigm FBS 89510-194 074B17 3 Testing Lab Control FBS — — 4 VWR Seradigm FB Essence 10805-184 048B16 5 GE Hyclone FBS SH30071.02 AB10104797 6 GE Hyclone FBS SH30071.02 AB10095803 7 ThermoFisher Gibco FBS A3160501 1883391 8 ThermoFisher Gibco FBS A3160501 1876851 the quality of FBS in cell culture. One of the most effective approaches is low-density plating efficiency testing.[1, 2] Plating efficiency is an individual characteristic of each adherent cell line (adhered /plated × 100). At clonal seeding density, the cells are unable to adequately condition the medium and must depend heavily on the nutritional capacity of the culture medium. The experimental design used in these two plating efficiency studies is based upon protocols cited above.[1, 2] 1.1 Materials and Methods Plating efficiency performance testing was conducted by an independent commercial testing lab on randomly selected production lots of FBS from three vendors (VWR Seradigm, GE HyClone, and ThermoFisher Gibco); two lots from each vendor (Table 1). FBS lots were tested in triplicate at four concentrations: 10 %, 7.5 %, 5.0 %, and 2.5 %. The FBS control was the test lab’s in-house lot to which all three cell lines were adapted pre-assay. The FBS control lot was not identical to any of the TA lots. Additionally, one lot of VWR Seradigm FB Essence, an FBS alternative, was included for comparison with this FBS performance challenge. Three adherent-dependent cell types were obtained from ATCC: CCL-34 (MDCK), CCL-75 (WI-38), and CCL-61 (CHO-K1). MDCK and CHO-K1 are cell lines that can be passaged indefinitely. WI-38 is a well-characterized normal human cell with
{"title":"Performance Challenging Fetal Bovine Serum (FBS) and FBS Alternatives","authors":"W. Siegel","doi":"10.12665/j17oa.siegel","DOIUrl":"https://doi.org/10.12665/j17oa.siegel","url":null,"abstract":"Growth performance testing in cell culture is an effective approach to making serum suitability and purchase decisions.[1] An independent commercial testing lab conducted two separate and sequential growth promotion studies to underscore the need for pre-purchase lot performance testing with: (1) FBS; and (2) FBS alternatives. Results from both studies are presented here to compare and contrast: • FBS lots to each other • FBS alternatives lots to each other • FBS alternatives lots to FBS FBS alternatives are included because they are often overlooked as a cost-effective substitute for FBS, providing, in many cases, equivalent performance. It is advisable to avoid preconceived notions con cern ing the quality or performance of a serum product without considering the culture system, culture con ditions, and the subject cells, which can all have a material impact on its performance in cell culture. Test – then decide. 1. FBS Performance Challenge Test article (TA) lot performance was evaluated with three different cell lines at four TA concentrations. Additionally, the impact of TA concentration used in the cell culture medium was examined. FBS end-users employ various methods for assessing TABLE 1. Test article key, FBS performance challenge. TA # Supplier Description Catalog # Lot # 1 VWR Seradigm FBS 89510-194 013B16 2 VWR Seradigm FBS 89510-194 074B17 3 Testing Lab Control FBS — — 4 VWR Seradigm FB Essence 10805-184 048B16 5 GE Hyclone FBS SH30071.02 AB10104797 6 GE Hyclone FBS SH30071.02 AB10095803 7 ThermoFisher Gibco FBS A3160501 1883391 8 ThermoFisher Gibco FBS A3160501 1876851 the quality of FBS in cell culture. One of the most effective approaches is low-density plating efficiency testing.[1, 2] Plating efficiency is an individual characteristic of each adherent cell line (adhered /plated × 100). At clonal seeding density, the cells are unable to adequately condition the medium and must depend heavily on the nutritional capacity of the culture medium. The experimental design used in these two plating efficiency studies is based upon protocols cited above.[1, 2] 1.1 Materials and Methods Plating efficiency performance testing was conducted by an independent commercial testing lab on randomly selected production lots of FBS from three vendors (VWR Seradigm, GE HyClone, and ThermoFisher Gibco); two lots from each vendor (Table 1). FBS lots were tested in triplicate at four concentrations: 10 %, 7.5 %, 5.0 %, and 2.5 %. The FBS control was the test lab’s in-house lot to which all three cell lines were adapted pre-assay. The FBS control lot was not identical to any of the TA lots. Additionally, one lot of VWR Seradigm FB Essence, an FBS alternative, was included for comparison with this FBS performance challenge. Three adherent-dependent cell types were obtained from ATCC: CCL-34 (MDCK), CCL-75 (WI-38), and CCL-61 (CHO-K1). MDCK and CHO-K1 are cell lines that can be passaged indefinitely. WI-38 is a well-characterized normal human cell with","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49013938","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 : 2018-04-16DOI: 10.12665/J17OA.WITCHER.0416
Mark Witcher
{"title":"Integrating Development Tools into the Process Validation Lifecycle to Achieve Six Sigma Pharmaceutical Quality","authors":"Mark Witcher","doi":"10.12665/J17OA.WITCHER.0416","DOIUrl":"https://doi.org/10.12665/J17OA.WITCHER.0416","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43827372","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}
Sue A. Brown, B. Croonenborghs, Kevin Head, Mara Senescu, R. Nims, M. Plavsic, R. Versteegen
{"title":"Gamma Irradiation of Animal Serum: Maintaining the Cold Chain Throughout the Process","authors":"Sue A. Brown, B. Croonenborghs, Kevin Head, Mara Senescu, R. Nims, M. Plavsic, R. Versteegen","doi":"10.12665/J17OA.BROWN","DOIUrl":"https://doi.org/10.12665/J17OA.BROWN","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42006520","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}
The continued use of animal serum as an important component in biotechnology manufacturing processes has raised questions regarding both the reliability of geographic origin and possible adulteration of product. The International Serum Industry Association (ISIA) has implemented a traceability certification program designed to demonstrate traceability from slaughterhouse or abattoir to the end-user. This is based on an audit performed by an independent, approved third-party auditor according to an approved audit plan, using a detailed audit checklist. Recent advances have led to the development of a complementary testing program to determine geographic origin of material. The methodology described in this paper differentiates fetal bovine serum from newborn calf serum on the basis of biochemical composition. A Method for Differentiating Fetal Bovine Serum from Newborn Calf Serum
{"title":"A Method for Differentiating Fetal Bovine Serum from Newborn Calf Serum","authors":"M. Cheever, R. Versteegen, A. Master","doi":"10.12665/J16OA.CHEEVER","DOIUrl":"https://doi.org/10.12665/J16OA.CHEEVER","url":null,"abstract":"The continued use of animal serum as an important component in biotechnology manufacturing processes has raised questions regarding both the reliability of geographic origin and possible adulteration of product. The International Serum Industry Association (ISIA) has implemented a traceability certification program designed to demonstrate traceability from slaughterhouse or abattoir to the end-user. This is based on an audit performed by an independent, approved third-party auditor according to an approved audit plan, using a detailed audit checklist. Recent advances have led to the development of a complementary testing program to determine geographic origin of material. The methodology described in this paper differentiates fetal bovine serum from newborn calf serum on the basis of biochemical composition. A Method for Differentiating Fetal Bovine Serum from Newborn Calf Serum","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43725412","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":"Novel Lipid Delivery Mechanism of Cell-Ess Increases Higher Order Glycoforms and the Consistency of Glycan Patterns on Monoclonal Antibodies Produced by CHO Cells","authors":"A. Elhofy, Justin A. Beller","doi":"10.12665/J16OA.ELHOFY","DOIUrl":"https://doi.org/10.12665/J16OA.ELHOFY","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45024595","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":"Analyzing and Managing Biopharmaceutical Risks by Building a System Risk Structure (SRS) for Modeling the Flow of Threats Through a Network of Manufacturing Processes","authors":"Mark Witcher","doi":"10.12665/J16OA.WITCHER","DOIUrl":"https://doi.org/10.12665/J16OA.WITCHER","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48935113","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":"Pondering Different Scales of Knowledge","authors":"V. Luckow","doi":"10.12665/J16OA.LUCKOW","DOIUrl":"https://doi.org/10.12665/J16OA.LUCKOW","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42562947","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 : 2017-09-19DOI: 10.12665/J16OA.REMINGTON
K. Remington, T. Tagmyer
{"title":"Demonstration of Porcine Circovirus Type 2 Inactivation by the Low pH Step of the Trypsin Manufacturing Process Using a New Infectivity Assay","authors":"K. Remington, T. Tagmyer","doi":"10.12665/J16OA.REMINGTON","DOIUrl":"https://doi.org/10.12665/J16OA.REMINGTON","url":null,"abstract":"","PeriodicalId":88836,"journal":{"name":"Bioprocessing","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43774147","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：