Hybrid modeling for quality by design and PAT‐benefits and challenges of applications in biopharmaceutical industry

Biotechnology Journal - Tập 9 Số 6 - Trang 719-726 - 2014
Moritz von Stosch1, Steven Davy2, Kjell François3, Vytautas Galvanauskas4, Jan‐Martijn Hamelink5, A. Luebbert6, Martin J. Mayer7, Rui Oliveira8,1, Ronan O’Kennedy9, P.D. Rice5, Jarka Glassey10
1REQUIMTE, Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa, Caparica, Portugal
2NNE Pharmaplan, Gentofte, Denmark
3Siemens NV, Huizingen, Belgium
4Process Control Department, Kaunas University of Technology, Kaunas, Lithuania
5GlaxoSmithKline Vaccines, Laval, Canada
6Center for Bioprocess Engineering, Institute of Biochemistry and Biotechnology, University Halle-Wittenberg, Halle, Germany
7Evon GmbH, Gleisdorf, Austria
8IBET/ITQB, Oeiras and Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa, Caparica, Portugal
9FUJIFILM Diosynth Biotechnologies, Billingham, UK
10CEAM, Newcastle University, Newcastle upon Tyne, UK

Tóm tắt

AbstractThis report highlights the drivers, challenges, and enablers of the hybrid modeling applications in biopharmaceutical industry. It is a summary of an expert panel discussion of European academics and industrialists with relevant scientific and engineering backgrounds. Hybrid modeling is viewed in its broader sense, namely as the integration of different knowledge sources in form of parametric and nonparametric models into a hybrid semi‐parametric model, for instance the integration of fundamental and data‐driven models. A brief description of the current state‐of‐the‐art and industrial uptake of the methodology is provided. The report concludes with a number of recommendations to facilitate further developments and a wider industrial application of this modeling approach. These recommendations are limited to further exploiting the benefits of this methodology within process analytical technology (PAT) applications in biopharmaceutical industry.

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Biotechnology Journal

Tập 9 Số 6

719-726

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