Continuous Manufacturing Development, Production and Quality

Solid dosage forms are still the most common dosage form, first and foremost tablets without any pioneering developments in the recent years. But driven by only a few pharmaceutical companies more and more of the global players started to invest in continuous manufacturing (CM). Companies like GSK, Pfizer; Johnson & Johnson and Vertex have been in the news lately. But also the Biotech Industry started to invest in CM. Upstream Processing is the more common area, but lately also Downstream Processes have been developed to be run continuously.

A shift from batch to continuous manufacturing could be one of the largest paradigm changes since the system of validation & qualification came up years ago.

Continuous manufacturing is data driven and by gaining this flood of information two topics become very important: process control and process monitoring. A vast amount of data has to be evaluated in order to control the process and to decide whether material can be collected or has to be rejected. This fundamental shift is also a major challenge for the Quality Unit. The Quality Management System has to be adapted to also cover continuous processes.

Regulating authorities, first of all the FDA, also encourage the transition from batch to continuous production. They expect an increase in product safety while equipment suppliers promote a decrease of production costs. But with a continuous mode of operation new questions raise:

Listen to companies who already did the transition and learn how they answered the questions above.