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 ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

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 ...

Using continuous processing instead of batch-based processing provides therapeutic manufacturers with a number of advantages. For example, the continuous approach can ...

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 ...

I have been openly critical of American management and leadership. In my last column, you read my thoughts on a new style of leadership I call lean leadership. It requires that leaders exhibit ...

As lentiviral vector (LVV) programs advance toward larger clinical trials and commercialization, manufacturing platforms and ...