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According to ICH Q8 guidelines, the biopharmaceutical manufacturer submits a design space (DS) definition as part of the regulatory approval application, in which case process parameter (PP) deviations within this space are not considered a change an
Externí odkaz:
http://arxiv.org/abs/2304.14666
Publikováno v:
In Bioresource Technology May 2024 399
Publikováno v:
In Chemical Engineering Science 5 April 2024 287
Publikováno v:
In Computers and Chemical Engineering April 2024 183
Autor:
Romann, Patrick, Vuillemin, Thomas, Pavone, Silvia, Jordan, Martin, Perilleux, Arnaud, Souquet, Jonathan, Bielser, Jean-Marc, Herwig, Christoph, Villiger, Thomas K.
Publikováno v:
In Journal of Biotechnology 10 March 2024 383:73-85
Publikováno v:
In Process Biochemistry January 2024 136:191-201
Autor:
García Aponte, Oscar Fabian, Kozma, Bence, Egger, Dominik, Kasper, Cornelia, Herwig, Christoph
Publikováno v:
In Biochemical Engineering Journal July 2023 196
Publikováno v:
In Computers and Chemical Engineering May 2023 173