Quality by design: Industrial case studies on defining and implementing design space for pharmaceutical processes - Part 1

BioPharm International

Volumn 21, Issue 12, 2008, Pages

  Rathore, Anurag S ^a   Saleki Gerhardt, Azita ^c   Montgomery, Stephen H ^b   Tyler, Stephen M ^c  

^a AMGEN INC   (United States)

^b LLP ^*  (United States)

^c ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ANALYTICAL PARAMETERS; ARTICLE; CASE STUDY; CHROMATOGRAPHY; CLINICAL EFFECTIVENESS; COMMERCIAL PHENOMENA; CRYSTALLIZATION; DRUG EFFICACY; DRUG MARKETING; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HIGH TEMPERATURE PROCEDURES; INTERNATIONAL COOPERATION; MEDICAL TECHNOLOGY; PH MEASUREMENT; PRACTICE GUIDELINE; PROCESS DESIGN; PROCESS DEVELOPMENT; PROCESS MONITORING; QUALITY CONTROL; RISK MANAGEMENT; SCORING SYSTEM; STANDARDIZATION; STATISTICAL ANALYSIS; STATISTICAL MODEL; VALIDATION PROCESS;

EID: 59649095082     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. US Food and Drug Administration (FDA). Guidance for Industry. Q8, Pharmaceutical Development. Rockville, MD; 2006 May.
2. US FDA. PAT Guidance for Industry - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Rockville, MD; 2004 Sept.
3. US FDA. Guidance for Industry. Q9 Quality Risk Management. Rockville, MD; 2006 June.
4. Nail SL, Searles JA. Elements of quality by design in development and scale-up of freeze-dried parenterals. BioPharm Int. 2008 Jan;21(1):44-52.
5. Cook S, Patton KA, Bazemore LR. Quality by design in the CMO environment. BioPharm Int. 2007 Dec;20(12):28-37.
6. Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol Prog. 2008;24:655-662.
7. Rathore AS, Branning R, Cecchini D. Design space for biotech products. BioPharm Intl. 2007 April;20(5):36-40.
8. Seely J. Process Characterization. In: Rathore AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals. Boca Raton, FL: Taylor & Francis; 2005. p. 31-68.
9. Seely RJ, Haury J. Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes. In Rathore AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals. Boca Raton, FL: Taylor & Francis; 2005. p. 13-30.