Toward in silico CMC: An industrial collaborative approach to model‐based process development
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Gang Wang | Tobias Hahn | Fabrice Schlegel | Thomas Wucherpfennig | Arne Staby | Eric von Lieres | Matthew Flamm | David Roush | Bruno Marques | Jasper Lin | John Welsh | Francis Insaidoo | Emmanouil Papadakis | Camille L. Bilodeau | Larry Sun | Steve Benner | Richard Willson | Ernst Broberg Hansen | Abraham Lenhoff | Deenesh K. Babi | Dilip Asthagiri | Deenesh K Babi | Camille Bilodeau | Giorgio Carta | Philipp Ernst | Mark Fedesco | Sean Fitzgibbon | Jan Griesbach | Tobias Grosskopf | Stephen Hunt | Henrik Marke | Marcel Stenvang | Peter M Tessier | Robert Todd | Oleksandr Zavalov | G. Wang | G. Carta | S. FitzGibbon | T. Wucherpfennig | D. Roush | A. Lenhoff | E. von Lieres | Francis Insaidoo | D. Asthagiri | P. Tessier | Jasper C. Lin | E. Papadakis | A. Staby | T. Grosskopf | Tobias Hahn | J. Welsh | Steven W Benner | O. Zavalov | Marcel R Stenvang | E. Hansen | F. Schlegel | P. Ernst | R. Willson | R. Todd | Mark Fedesco | Henrik S. Marke | J. Griesbach | Bruno Marques | S. Hunt | M. Flamm | Larry Sun | Richard C. Willson | Oleksandr Zavalov | Sean I. FitzGibbon
[1] S. Hunt,et al. Modeling Preparative Cation Exchange Chromatography of Monoclonal Antibodies , 2017 .
[2] Keith McDonald,et al. ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities , 2012 .
[3] Anurag S. Rathore,et al. Model‐Based Preparative Chromatography Process Development in the QbD Paradigm , 2017 .
[4] Pedro M. Castro,et al. Scope for industrial applications of production scheduling models and solution methods , 2014, Comput. Chem. Eng..
[5] Jay Sanyal,et al. A generalized approach to model oxygen transfer in bioreactors using population balances and computational fluid dynamics , 2005 .
[6] Michael Baldea,et al. Modular manufacturing processes: Status, challenges, and opportunities , 2017 .
[7] René Holm,et al. Q8(R2): Pharmaceutical Development , 2017 .
[8] Federico Rischawy,et al. Good modeling practice for industrial chromatography: Mechanistic modeling of ion exchange chromatography of a bispecific antibody , 2019, Comput. Chem. Eng..
[9] Guan Wang,et al. Computational fluid dynamics simulation of an industrial P. chrysogenum fermentation with a coupled 9-pool metabolic model : Towards rational scale-down and design optimization , 2018 .
[10] Ernst Broberg Hansen. Chromatographic Scale‐Up on a Volume Basis , 2017 .
[11] Lilli Møller Andersen,et al. Quality Risk Management , 2021, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.
[12] Saeed Izadi,et al. Highland games: A benchmarking exercise in predicting biophysical and drug properties of monoclonal antibodies from amino acid sequences , 2020, Biotechnology and bioengineering.
[13] Eric von Lieres,et al. Chromatography Analysis and Design Toolkit (CADET) , 2014, Comput. Chem. Eng..
[14] Jennifer M Pollard,et al. Prediction of lab and manufacturing scale chromatography performance using mini-columns and mechanistic modeling. , 2019, Journal of chromatography. A.
[15] Jürgen Hubbuch,et al. Modeling and simulation of anion-exchange membrane chromatography for purification of Sf9 insect cell-derived virus-like particles. , 2016, Journal of chromatography. A.
[16] Jürgen Hubbuch,et al. Calibration‐free inverse modeling of ion‐exchange chromatography in industrial antibody purification , 2016 .
[17] Matteo Salvalaglio,et al. Molecular modelling of the affinity chromatography of proteins: Status and perspectives , 2012 .
[18] Sarfaraz Niazi,et al. Pharmaceutical Quality System , 2014, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.
[19] P. A. Rolandi,et al. The Unreasonable Effectiveness of Equations: Advanced Modeling For Biopharmaceutical Process Development , 2019, Computer Aided Chemical Engineering.
[20] Alois Jungbauer,et al. Protein Chromatography: Process Development and Scale-Up , 2010 .
[21] Modular Plants Flexible chemical production by modularization and standardization – status quo and future trends , 2017 .
[22] Anurag S. Rathore,et al. Preparative Chromatography for Separation of Proteins , 2017 .
[23] Jürgen Hubbuch,et al. Prediction uncertainty assessment of chromatography models using Bayesian inference. , 2019, Journal of chromatography. A.
[24] Andrew L. Zydney,et al. Bioprocess membrane technology , 2007 .
[25] Ralf Takors,et al. Predictability of kLa in stirred tank reactors under multiple operating conditions using an Euler–Lagrange approach , 2016 .
[26] Rebecca Frauzem,et al. A generic methodology for processing route synthesis and design based on superstructure optimization , 2017, Comput. Chem. Eng..
[27] Lars Hagel,et al. Gel filtration: size exclusion chromatography. , 2011, Methods of biochemical analysis.