Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification technology, with investment expected to rise in the coming years and the focus shifting toward biologics. This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach...
This article revisits the concept of phased engineering, procurement, and construction (EPC) and updates it with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects. Enhancing the relationship between phases of a project, advanced planning, and more formal management of...
Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as vaccines) would, in principle, be even more justified for both quality and business gains. This article briefly reviews continuous...
