title: Hybrid modeling for quality by design and PAT-benefits and challenges of applications in biopharmaceutical industry.
abstract: 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.
authors.affiliation: REQUIMTE, Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa, Caparica, Portugal.
authors.forename: Moritz
authors.initials: M
authors.lastname: von Stosch
authors.forename: Steven
authors.initials: S
authors.lastname: Davy
authors.forename: Kjell
authors.initials: K
authors.lastname: Francois
authors.forename: Vytautas
authors.initials: V
authors.lastname: Galvanauskas
authors.forename: Jan-Martijn
authors.initials: JM
authors.lastname: Hamelink
authors.forename: Andreas
authors.initials: A
authors.lastname: Luebbert
authors.forename: Martin
authors.initials: M
authors.lastname: Mayer
authors.forename: Rui
authors.initials: R
authors.lastname: Oliveira
authors.forename: Ronan
authors.initials: R
authors.lastname: O'Kennedy
authors.forename: Paul
authors.initials: P
authors.lastname: Rice
authors.forename: Jarka
authors.initials: J
authors.lastname: Glassey
mesh_terms: D001702:Biopharmaceutics / Q000379:methods* / Q000592:standards; D001709:Biotechnology / Q000379:methods / Q000592:standards*; D004345:Drug Industry / Q000592:standards; D006801:Humans; D008962:Models, Theoretical; D011786:Quality Control
keywords: Biopharmaceuticals; Bioprocess development; Hybrid modeling; Process analytical technology; Quality by design