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) ...

ISA106 started with the goal of developing standards, recommended practices, and technical reports on the design and implementation of procedures for automating continuous process operations. The ...

Anything that you do well is worth doing better over time. The term "continuous improvement" describes a process practiced by quality engineers but it speaks to something that every conscientious ...

This Comment explores why continuous crystallization, despite its success in other industries, remains underutilized in pharmaceutical manufacturing. Among other challenges, we highlight two core ...

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 ...

Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...

Continuous manufacturing is finally gaining traction in the pharmaceutical industry, but development of the necessary production technologies is, fittingly, a continuous process. Ultimately, the drawn ...

What does CI/CD stand for? Continuous integration (CI) and continuous delivery (CD), also known as CI/CD, embodies a culture and set of operating principles and practices that application development ...