Conclusion
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, asrathore@biotechcmz.com
.
References
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