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Hybrid modeling for quality by design and PAT‐benefits and challenges of applications in biopharmaceutical industry
Author(s) -
von Stosch Moritz,
Davy Steven,
Francois Kjell,
Galvanauskas Vytautas,
Hamelink JanMartijn,
Luebbert Andreas,
Mayer Martin,
Oliveira Rui,
O'Kennedy Ronan,
Rice Paul,
Glassey Jarka
Publication year - 2014
Publication title -
biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.144
H-Index - 84
eISSN - 1860-7314
pISSN - 1860-6768
DOI - 10.1002/biot.201300385
Subject(s) - biopharmaceutical , process (computing) , computer science , quality (philosophy) , parametric statistics , management science , risk analysis (engineering) , quality by design , systems engineering , biochemical engineering , engineering , business , microbiology and biotechnology , operations management , philosophy , statistics , mathematics , epistemology , biology , operating system , downstream (manufacturing)
This 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.