This article, which is Part 2 of the series on continuous manufacturing focuses on the uptake of continuous manufacturing by the pharmaceutical industry for both API and drug products, scaleup to pilot scale and successes in commercialization. Adoption of continuous manufacturing by CRO’s/CDMO’s is also reviewed. Challenges associated with continuous manufacturing are outlined.
Deepak Hegde, Ph.D., M.F.M, is an industrial pharmacist by training. He has a been involved in development and commercialization of both innovative and generic drugs from a very early phase of development to technical transfers for commercial manufacturing sites, for the past 25 years. During his career, he has worked Rhone Poulenc, Novartis (Sandoz), USV Ltd., WuXi AppTec and GSK. He is currently working with EOC Pharma. as Chief Technology officer.
Since the promulgation of the Hatch-Waxman Act in 1984, in order to promote drug competition and improve public drug availability, FDA has formulated a number of policies aimed at accelerating the marketing of generic drugs.
According to statistics, the market size of China’s oncology treatment industry reached RMB387.6 billion in 2020, with a compound annual growth rate of 10.3% in the past five years as compared to RMB261.4 billion in 2016, and this market size is expected