In silico process characterization for biopharmaceutical development following the quality by design concept

With the quality by design (QbD) initiative, regulatory authorities demand a consistent drug quality originating from a well‐understood manufacturing process. This study demonstrates the application of a previously published mechanistic chromatography model to the in silico process characterization...

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Veröffentlicht in:	Biotechnology progress 2021-11, Vol.37 (6), p.e3196-n/a
Hauptverfasser:	Saleh, David, Wang, Gang, Rischawy, Federico, Kluters, Simon, Studts, Joey, Hubbuch, Jürgen
Format:	Artikel
Sprache:	eng
Schlagworte:	Acceptance criteria Animals Antibodies, Monoclonal - analysis Antibodies, Monoclonal - chemistry Antibodies, Monoclonal - isolation & purification antibody purification Biological Products - analysis Biological Products - chemistry Biological Products - isolation & purification Biological Products - standards Biopharmaceuticals cation exchange chromatography CHO Cells Chromatography, Ion Exchange Computer Simulation Cricetinae Cricetulus Drug Design - methods Drug Development in silico process characterization Manufacturing Manufacturing industry Mathematical models mechanistic chromatography modeling Monoclonal antibodies Parameter identification Process parameters Quality management Regulatory agencies Stochasticity Workflow
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