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

Biotechnology Journal

Volumn 9, Issue 6, 2014, Pages 719-726

  von Stosch, Moritz ^a   Davy, Steven ^b   Francois, Kjell ^c   Galvanauskas, Vytautas ^d   Hamelink, Jan Martijn ^e   Luebbert, Andreas ^f   Mayer, Martin ^c   Oliveira, Rui ^a,g   O'Kennedy, Ronan ^h   Rice, Paul ^e   Glassey, Jarka ⁱ  

^a UNIVERSIDADE NOVA DE LISBOA   (Portugal)

^b NNE Pharmaplan   (Denmark)

^c Siemens NV ^*  (Austria)

^d KAUNAS UNIVERSITY OF TECHNOLOGY   (Lithuania)

^e GLAXOSMITHKLINE   (Canada)

^f MARTIN LUTHER UNIVERSITY HALLE WITTENBERG   (Germany)

^g INSTITUTO DE TECNOLOGIA QUÍMICA E BIOLÓGICA   (Portugal)

^h Fujifilm Diosynth Biotechnologies   (United Kingdom)

ⁱ NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

Biopharmaceuticals; Bioprocess development; Hybrid modeling; Process analytical technology; Quality by design

Indexed keywords

INDUSTRIAL APPLICATIONS; MODELS;

BIOPHARMACEUTICALS; BIOPROCESS DEVELOPMENT; HYBRID MODEL; PROCESS ANALYTICAL TECHNOLOGY; QUALITY BY DESIGNS;

INDUSTRY;

BIOSIMILAR AGENT;

ARTICLE; COMMERCIAL PHENOMENA; DRUG INDUSTRY; DRUG MANUFACTURE; FERMENTATION; HUMAN; HYBRID; PATIENT SAFETY; PHARMACEUTICS; PRIORITY JOURNAL; PROCESS CONTROL; PROCESS DEVELOPMENT; PROCESS MONITORING; PROCESS OPTIMIZATION; PROCESS TECHNOLOGY; SCALE UP; TOTAL QUALITY MANAGEMENT; BIOPHARMACEUTICS; BIOTECHNOLOGY; HUMANS; METHODS; MODELS, THEORETICAL; QUALITY CONTROL; STANDARDS;

BIOPHARMACEUTICS; BIOTECHNOLOGY; DRUG INDUSTRY; HUMANS; MODELS, THEORETICAL; QUALITY CONTROL;

EID: 84901654992     PISSN: 18606768     EISSN: 18607314     Source Type: Journal    
DOI: 10.1002/biot.201300385     Document Type: Article

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