Quality by Design for Biologics and Biosimilars - Pharmaceutical Technology

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PharmTech Europe

Quality by Design for Biologics and Biosimilars
The author provides an overview of QbD implmentation for biopharmaceuticals.

Pharmaceutical Technology
Volume 35, Issue 3, pp. 64-68


The economics of developing and commercializing follow-on biologics, in particular in Asia, necessitate that manufacturers cannot merely replicate process and product development practices that have been established at US and European manufacturers. The raised expectations of the regulatory agencies, as represented by the PAT and ICH guidelines, will need to be met. For QbD implementation, the next decade is likely to witness an evolution into a more cost-efficient approach, driven by innovation in the areas mentioned herein and beyond.

Anurag S. Rathore is a faculty member in the Department of Chemical Engineering at the Indian Institute of Technology, Hauz Khas, New Delhi, 110016, India, +91 96 5077 0650,


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.


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