Regulatory Progress - Global Advancement of Continuous Manufacturing for Pharma
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the cost of purchasing the continuous equipment, the resources and expertise required for additional in-process monitoring and testing, and the automation complexity of the integrated system. However, the economic benefits afforded by CM, specifically from optimizing supply chains by manufacturing according to variable product demand, provide a strong justification for this investment. Furthermore, several regulatory agencies have recently approved solid oral dosage forms for multiple new chemical entities as well as an already approved and marketed product, and these approvals have generated significant interest in and excitement about this novel approach to manufacturing pharmaceuticals.