Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test
Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.ABSTRACTHere we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries. The study also provided an opportunity to asse...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2023 Category: Biotechnology Authors: Rob Tierney Jason Hockley Shalini Rajagopal Paul Stickings Source Type: research

The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report
Biologicals. 2023 Aug 27;84:101702. doi: 10.1016/j.biologicals.2023.101702. Online ahead of print.ABSTRACTThe rabbit pyrogen test (RPT) was the benchmark for pyrogenicity testing, but scientific advancements have provided innovative and humane methods, such as the in vitro monocyte-activation test (MAT). However, transitioning from the RPT to the MAT has been challenging. The European Directorate for the Quality of Medicines & HealthCare, the Council of Europe, and the European Partnership for Alternative Approaches to Animal Testing jointly hosted an international conference entitled "The future of pyrogenicity testin...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 29, 2023 Category: Biotechnology Authors: Gwena ël Cirefice Katrin Sch ütte Ingo Spreitzer Emmanuelle Charton Shahjahan Shaid Laura Viviani Michelle Rubbrecht Irene Manou Source Type: research

The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report
Biologicals. 2023 Aug 27;84:101702. doi: 10.1016/j.biologicals.2023.101702. Online ahead of print.ABSTRACTThe rabbit pyrogen test (RPT) was the benchmark for pyrogenicity testing, but scientific advancements have provided innovative and humane methods, such as the in vitro monocyte-activation test (MAT). However, transitioning from the RPT to the MAT has been challenging. The European Directorate for the Quality of Medicines & HealthCare, the Council of Europe, and the European Partnership for Alternative Approaches to Animal Testing jointly hosted an international conference entitled "The future of pyrogenicity testin...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 29, 2023 Category: Biotechnology Authors: Gwena ël Cirefice Katrin Sch ütte Ingo Spreitzer Emmanuelle Charton Shahjahan Shaid Laura Viviani Michelle Rubbrecht Irene Manou Source Type: research

The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report
Biologicals. 2023 Aug 27;84:101702. doi: 10.1016/j.biologicals.2023.101702. Online ahead of print.ABSTRACTThe rabbit pyrogen test (RPT) was the benchmark for pyrogenicity testing, but scientific advancements have provided innovative and humane methods, such as the in vitro monocyte-activation test (MAT). However, transitioning from the RPT to the MAT has been challenging. The European Directorate for the Quality of Medicines & HealthCare, the Council of Europe, and the European Partnership for Alternative Approaches to Animal Testing jointly hosted an international conference entitled "The future of pyrogenicity testin...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 29, 2023 Category: Biotechnology Authors: Gwena ël Cirefice Katrin Sch ütte Ingo Spreitzer Emmanuelle Charton Shahjahan Shaid Laura Viviani Michelle Rubbrecht Irene Manou Source Type: research

CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells
Biologicals. 2023 Aug 12;83:101697. doi: 10.1016/j.biologicals.2023.101697. Online ahead of print.ABSTRACTMDCK is currently the main cell line used for influenza vaccine production in culture. Previous studies have reported that MDCK cells possess tumorigenic ability in nude mice. Although complete cell lysis can be ensured during vaccine production, host cell DNA released after cell lysis may still pose a risk for tumorigenesis. Greater caution is needed in the production of human vaccines; therefore, the use of gene editing to establish cells incapable of forming tumors may significantly improve the safety of influenza v...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 14, 2023 Category: Biotechnology Authors: Zhenbin Liu Mengyuan Pei Geng Liu Zhenyu Qiu Siya Wang Zilin Qiao Jiamin Wang Dongwu Jin Jiayou Zhang Kai Duan Xuanxuan Nian Zhongren Ma Xiaoming Yang Source Type: research

CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells
Biologicals. 2023 Aug 12;83:101697. doi: 10.1016/j.biologicals.2023.101697. Online ahead of print.ABSTRACTMDCK is currently the main cell line used for influenza vaccine production in culture. Previous studies have reported that MDCK cells possess tumorigenic ability in nude mice. Although complete cell lysis can be ensured during vaccine production, host cell DNA released after cell lysis may still pose a risk for tumorigenesis. Greater caution is needed in the production of human vaccines; therefore, the use of gene editing to establish cells incapable of forming tumors may significantly improve the safety of influenza v...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 14, 2023 Category: Biotechnology Authors: Zhenbin Liu Mengyuan Pei Geng Liu Zhenyu Qiu Siya Wang Zilin Qiao Jiamin Wang Dongwu Jin Jiayou Zhang Kai Duan Xuanxuan Nian Zhongren Ma Xiaoming Yang Source Type: research