Quality by Design: Industrial case studies on defining and implementing design space for pharmaceutical processes

BioPharm International

Volumn 22, Issue 1, 2009, Pages 36-44

  Rathore, Anurog S ^a   Montgomery, Stephen N ^b   SaIeld Gerhordt, Azito ^b   Tyler, Stephen M ^b  

^a AMGEN INC   (United States)

^b McDonnell Boehnen Hulbert and LLP ^*

Author keywords

[No Author keywords available]

Indexed keywords

ANION EXCHANGE CHROMATOGRAPHY; CELL DENSITY; CRYSTALLIZATION; DRUG DESIGN; DRUG EFFICACY; DRUG FORMULATION; DRUG IMPURITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG SOLUBILITY; FERMENTATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; NEAR INFRARED SPECTROSCOPY; PROCESS DEVELOPMENT; PROCESS TECHNOLOGY; QUALITY CONTROL; REVIEW; SAMPLING ERROR; SCALE UP;

EID: 77951262254     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

1. US Food and Drug Administration. 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. Onoth S, Jenzsch M, Simutis R, Ludie;bbert A. Process analytical technology (PAT): batch-to- batch reproducibility of fermentation processes by robust process operational design and control. J Biotechnol. 2007;132:1SO-6.
4. Kirdar AO, Conner JS, Baclaski J, Rathore AS. Application of multivariate analysis towards biotech processes: Case study of a cell-culture unit operation. Biotech Prog. 2007;23:51-7
5. Johnson R, Yu 0, Kirdar A0, Annamalai A, Ahuja S, Ram K, Rathore, AS. Applications of multivariate data analysis (MVDA) for biotech processing. BioPharm Int. 2007 Oct;20(10):130-44. (Pubitemid 350110283)
6. Kirdar AD, Green KD, Rathore AS. Application of multivariate analysis for identification and resolution of a root cause for a bioprocessing application. Biotech Prog. 2008;24:720-6.
7. Rathore AS, Sharma A, Chillin D. Applying process analytical technology to biotech unit operations. BioPharm Int. 2006 Aug; 19(8):48-51.
8. Rathore AS, Yu M, Yeboah B, Sharma A. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol Bioeng. 2008;100:306-16. (Pubitemid 351758172)
9. Rathore AS, Branning R, Cecchini D. Design space for biotech products. BioPharm Intl. 2007 April;20(4):36-40. (Pubitemid 46658621)
10. Us FDA. Guidance for Industry: Q10 quality systems approach to pharmaceutical COMP regulations. Rockville, MD: 2006 sept.
11. Kozlowski S, Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv Drug Deliv Rev. 2006;58:707-22. (Pubitemid 44255854)
12. 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;24:655-62. (Pubitemid 351832721)
13. Yu LX, Lionberger RA, Raw AS, D'Costa R, Wu H, Hussain AS. Applications of process analytical technology to crystallization process. Adv Drug Deliv Rev. 2004;56:349-69. (Pubitemid 38201430)