Process Analytical Technology (PAT) for biopharmaceutical products: Part II. Concepts and applications

Biotechnology and Bioengineering

Volumn 105, Issue 2, 2010, Pages 285-295

  Read, E K ^a   Shah, R B ^a   Riley, B S ^a   Park, J T ^a   Brorson, K A ^a   Rathore, A S ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

Author keywords

Chemometrics; Lyophilization; NIR; Process analytical technology (PAT); Rapid microbiological techniques

Indexed keywords

BIOPHARMACEUTICAL PRODUCTS; CHEMOMETRICS; DESIGN SPACES; DOWNSTREAM-PROCESSING; GUIDANCE DOCUMENT; PROCESS ANALYTICAL TECHNOLOGY; PROCESS PARAMETERS; PRODUCT QUALITY; PRODUCT QUALITY CONTROL; QUALITY BY DESIGNS;

CUSTOMER SATISFACTION; DRUG PRODUCTS PLANTS; INFRARED DEVICES; TOTAL QUALITY MANAGEMENT;

QUALITY CONTROL;

ANALYTIC METHOD; BIOTECHNOLOGY; CASE REPORT; CELL CULTURE; CHEMOMETRICS; DRUG MANUFACTURE; FREEZE DRYING; HUMAN; MULTIVARIATE ANALYSIS; NEAR INFRARED SPECTROSCOPY; PRACTICE GUIDELINE; PROCESS TECHNOLOGY; PRODUCT DEVELOPMENT; QUALITY CONTROL; RAMAN SPECTROMETRY; REVIEW; ROOT CAUSE ANALYSIS;

BIOTECHNOLOGY; CELL CULTURE TECHNIQUES; DRUG INDUSTRY; FREEZE DRYING; MICROBIOLOGICAL TECHNIQUES; QUALITY CONTROL; SPECTROSCOPY, NEAR-INFRARED; SPECTRUM ANALYSIS, RAMAN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 74849096358     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22529     Document Type: Review

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