Designing in quality: Approaches to defining the design space for a monoclonal antibody process

BioPharm International

Volumn 23, Issue 5, 2010, Pages 26-40

  Banerjee, Amit ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

BIOREACTOR; CELL DENSITY; DRUG DESIGN; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SAFETY; FED BATCH REACTOR; PROCESS DEVELOPMENT; PROCESS TECHNOLOGY; QUALITY CONTROL; REVIEW; RISK ASSESSMENT;

EID: 77952051305     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. US Food and Drug Administration. Guidance for industry. Quality system approach to pharmaceutical CGMP regulations. Rockville, MD: 2006
2. International Conference on Harmonization (ICH). Q8(R1), Pharmaceutical development. Geneva, Switzerland; 2007.
3. US FDA. Pharmaceutical CGMPs for the 21st Century\a risk-based approach. Final report. Rockville, MD; 2004.
4. Ende D, Bronk KS, Mustakis J, O'Conor G, Santa Maria CL, Nosal R, Watson TJ. API Quality by Design. Example from the torcetrapib manufacturing process. J Pharm Innov. 2007;2(3-4):71-86
5. ICH. Q9, Quality risk management. Geneva, Switzerland; 2006
6. ICH. Q10, Pharmaceutical quality systems. Geneva, Switzerland; 2008.
7. Godavarti R, Petrone J, Robinson J, Wright R, Kelly BD. Scale down models for purification processes. Process. In: A. S. Rathore and Gail S. Sofer, editors, Validation in manufacturing of biopharmaceuticals. Boca Raton, FL: CRC Press, Taylor and Francis Group; 2005. p. 69-142,.
8. Godoy-Silva R, Chalmers JJ, Casnocha SA, Bass LA, Ma N. Physiological responses of CHO cells to repetitive hydrodynamic stress. Biotechnol bioeng. 2009;103(6):1103-1117