Quality-by-design for biotechnology-related pharmaceuticals

Biotechnology Journal

Volumn 4, Issue 5, 2009, Pages 600-609

  Mandenius, Carl Fredrik ^a   Graumann, Klaus ^b   Schultz, Torsten W ^c   Premstaller, Andreas ^b   Olsson, Ing Marie ^d   Petiot, Emma ^e   Clemens, Christoph ^c   Welin, Mats ^f  

^a LINKÖPING UNIVERSITY   (Sweden)

^b NOVARTIS PHARMA AG   (Switzerland)

^c BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^d Umetrics AB   (Sweden)

^e CNRS   (France)

^f MEDICAL PRODUCTS AGENCY   (Sweden)

Author keywords

Active pharmaceutical ingredients; Biopharmaceuticals; Design space; Design of Experiments; On line monitoringand control

Indexed keywords

NEW DRUG;

BIOTECHNOLOGY; CHEMOMETRIC ANALYSIS; CONFERENCE PAPER; DRUG DESIGN; DRUG INDUSTRY; DRUG QUALITY; DRUG SCREENING; DRUG SYNTHESIS; EUROPE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; INFORMATION PROCESSING; INFORMATION RETRIEVAL; NEAR INFRARED SPECTROSCOPY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROCESS MONITORING; QUALITY CONTROL; RAMAN SPECTROMETRY; RISK MANAGEMENT; WORKSHOP;

BIOPHARMACEUTICS; BIOREACTORS; BIOTECHNOLOGY; DRUG INDUSTRY; EDUCATION; FERMENTATION; MODELS, BIOLOGICAL; RESEARCH DESIGN;

EID: 68049113335     PISSN: 18606768     EISSN: 18607314     Source Type: Journal    
DOI: 10.1002/biot.200800333     Document Type: Conference Paper

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