Quality by design for biologics and biosimilars

Pharmaceutical Technology

Volumn 35, Issue 3, 2011, Pages 64-69

  Rathore, Anurag S ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; ETANERCEPT; HUMAN GROWTH HORMONE; INSULIN GLARGINE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; TRASTUZUMAB;

ANALYTIC METHOD; ARTICLE; BIOTECHNOLOGY; COST; COST CONTROL; DRUG APPROVAL; DRUG COST; DRUG DESIGN; DRUG EFFICACY; DRUG INDUSTRY; DRUG QUALITY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HIGH THROUGHPUT SCREENING; PHARMACEUTICS; PROCESS ANALYTICAL TECHNOLOGY; QUALITY BY DESIGN; QUALITY CONTROL; RISK MANAGEMENT;

EID: 80051893940     PISSN: 15432521     EISSN: 21507376     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. FDA, Guidance for Industry: PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (Rockville, MD, September, 2004.
2. ICH, Q8 Pharmaceutical Development (Geneva, November, 2007).
3. ICH, Q9 Quality Risk Management (Geneva, June 2006).
4. ICH, Q10 Pharmaceutical Quality Systems (Geneva, September, 2006).
5. A.S. Rathore, Pharm. Technol. Eur. 22 (2) 2010.
6. A.S. Rathore and H. Winkle, Nature Biotechnol. 27, 26-34 (2009).
7. S. Kozlowski and P. Swann, "Considerations for Biotechnology Product Quality by Design, " in Quality by Design for Biopharmaceuticals: Perspectives and Case Studies, Eds. A.S. Rathore and R. Mhatre (Wiley Interscience 2009), pp. 9-30.
8. A.S. Rathore, Trends in Biotechnol. 27 (2009), 546-553.
9. G. Walsh, Nature Biotechnol. 28 (2010), 917-924.
10. A.S. Rathore, Trends in Biotechnol. 27 (2009), 698-705.
11. R. Bhambure, K. Kumar, and A. S. Rathore, Trends in Biotechnol. 27 (2010), doi:10.1016/j.tibtech.2010.12.001.