On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report
Biologicals. 2023 Jul 27;83:101695. doi: 10.1016/j.biologicals.2023.101695. Online ahead of print.ABSTRACTRegulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Laura Viviani Elisabeth Balks Sonja Beken Anna-Maria Brady Rick Clayton Florence Cliquet Liys Desmayanti Silvia Fragoeiro Terrie Jo Hamtak David John Carmen Jungba ëck M Kalaivani Imke Kross Catherine Lang Ni Made Ria Isriyanthi Laurent Mallet Catherine Source Type: research

On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report
Biologicals. 2023 Jul 27;83:101695. doi: 10.1016/j.biologicals.2023.101695. Online ahead of print.ABSTRACTRegulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Laura Viviani Elisabeth Balks Sonja Beken Anna-Maria Brady Rick Clayton Florence Cliquet Liys Desmayanti Silvia Fragoeiro Terrie Jo Hamtak David John Carmen Jungba ëck M Kalaivani Imke Kross Catherine Lang Ni Made Ria Isriyanthi Laurent Mallet Catherine Source Type: research

On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report
Biologicals. 2023 Jul 27;83:101695. doi: 10.1016/j.biologicals.2023.101695. Online ahead of print.ABSTRACTRegulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Laura Viviani Elisabeth Balks Sonja Beken Anna-Maria Brady Rick Clayton Florence Cliquet Liys Desmayanti Silvia Fragoeiro Terrie Jo Hamtak David John Carmen Jungba ëck M Kalaivani Imke Kross Catherine Lang Ni Made Ria Isriyanthi Laurent Mallet Catherine Source Type: research

On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report
Biologicals. 2023 Jul 27;83:101695. doi: 10.1016/j.biologicals.2023.101695. Online ahead of print.ABSTRACTRegulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Laura Viviani Elisabeth Balks Sonja Beken Anna-Maria Brady Rick Clayton Florence Cliquet Liys Desmayanti Silvia Fragoeiro Terrie Jo Hamtak David John Carmen Jungba ëck M Kalaivani Imke Kross Catherine Lang Ni Made Ria Isriyanthi Laurent Mallet Catherine Source Type: research

On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report
Biologicals. 2023 Jul 27;83:101695. doi: 10.1016/j.biologicals.2023.101695. Online ahead of print.ABSTRACTRegulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Laura Viviani Elisabeth Balks Sonja Beken Anna-Maria Brady Rick Clayton Florence Cliquet Liys Desmayanti Silvia Fragoeiro Terrie Jo Hamtak David John Carmen Jungba ëck M Kalaivani Imke Kross Catherine Lang Ni Made Ria Isriyanthi Laurent Mallet Catherine Source Type: research

On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report
Biologicals. 2023 Jul 27;83:101695. doi: 10.1016/j.biologicals.2023.101695. Online ahead of print.ABSTRACTRegulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Laura Viviani Elisabeth Balks Sonja Beken Anna-Maria Brady Rick Clayton Florence Cliquet Liys Desmayanti Silvia Fragoeiro Terrie Jo Hamtak David John Carmen Jungba ëck M Kalaivani Imke Kross Catherine Lang Ni Made Ria Isriyanthi Laurent Mallet Catherine Source Type: research

On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report
Biologicals. 2023 Jul 27;83:101695. doi: 10.1016/j.biologicals.2023.101695. Online ahead of print.ABSTRACTRegulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Laura Viviani Elisabeth Balks Sonja Beken Anna-Maria Brady Rick Clayton Florence Cliquet Liys Desmayanti Silvia Fragoeiro Terrie Jo Hamtak David John Carmen Jungba ëck M Kalaivani Imke Kross Catherine Lang Ni Made Ria Isriyanthi Laurent Mallet Catherine Source Type: research

On-column virus inactivation by solvent/detergent treatment for a recombinant biological product
We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount ...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research