Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...

Key information is needed for excipients and their potential impact on continuous manufacturing processes. An essential factor to consider when developing a robust continuous manufacturing (CM) ...

As industry shifts to continuous biomanufacturing, engineers integrate process design, digital tools, automation, and ...

Continued process verification (CPV) is the third stage of the product lifecycle of any medicine either within the small or large molecule arena. The CPV is the subsequent step to process design ...