Quality-by-design as applied to the development and manufacturing of a lyophilized protein product

American Pharmaceutical Review

Volumn 12, Issue 7, 2009, Pages 20-24

  Jameel, Feroz ^a   Khan, Mansoor ^b  

^a AMGEN INC   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

PROTEIN;

DRUG FORMULATION; DRUG MANUFACTURE; FREEZE DRYING; PROCESS ANALYTICAL TECHNOLOGY; PROCESS OPTIMIZATION; PROCESS TECHNOLOGY; QUALITY BY DESIGN; QUALITY CONTROL; SHORT SURVEY;

EID: 74749095010     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (9)

1. Manning MC, Patel K, Borchardt RT. Stability of protein pharmaceuticals. Pharm Res., 1989, 6: 903-918 Pearlman R, Wang YJ. Formulation, Characterization, and Stability of Protein Drugs. (Series: Pharmaceutical Biotechnology, Vol. 9), Plenum Press, New York (1996) (ISBN 0-306-47452-2)
2. US Food and Drug Administration. Guidance for Industry. PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance. Pharmaceutical cGMPs. Rockville, MD; 2004 Sept. p. 1-21.
3. FDA, Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (Rockville, MD, Aug. 21, 2002).
4. ICH, ICH Q8: Pharmaceutical Development, Step 4 (Geneva, Nov. 10, 2005).
5. ICH, ICH Q8: (R1): Pharmaceutical Development Revision 1, Step 3 (draft, Geneva, Nov. 1, 2007).
6. ICH, ICH Q9: Quality Risk Management, Step 4 (Geneva, Nov. 9, 2005).
7. International Conference on Harmonization. Q10, Pharmaceutical Quality System. Geneva, Switzerland, 2007.
8. Guidance for Industry and Review Staff: Target Product Profile-A Strategic Development Process Tool, Draft Guidance, US Department of Health and Human Services Food and Drug Administration, March 2007.
9. Feroz Jameel and Mike Pikal "Design of a Formulation for Freeze Drying" chapter 18 in "Formulation and Process Development Strategies for Manufacturing of Biopharmaceuticals" Feroz Jameel and Susan Hershenson, editors, John Wiley & Sons, Inc. Accepted for publication, 2009