The Promise Of PCM: Getting To Maturity

By Bikash Chatterjee, Chief Executive Officer, Pharmatech Associates

Originally published by PharmaManufacturing.com, October 2022.

Two decades ago, the predominant perception was that pharma manufacturing and quality sensibilities were better suited to batch manufacturing. The volumes of most pharmaceutical products were much smaller than chemical processes — an industry in which continuous manufacturing was broadly used — making batch processes more suitable for pharma operations. However, the biggest hurdle in pursuing pharmaceutical continuous manufacturing (PCM) was the risk associated with CMC regulatory uncertainty.

Both the FDA and the International Council for Harmonization (ICH) recently released guidance on continuous manufacturing, providing insight into how companies would need to demonstrate control strategies and characterization for a continuous process. PCM offers a number of advantages for pharmaceutical companies, including streamlined development and scale-up and increased manufacturing flexibility.

Review the key drivers for PCM as well as the hurdles that stand in the way of industry-wide adoption.