ABOUT THE ECCPM FORUM
25-26 September 2019
The benefits of Continuous Manufacturing (CM) are evident: reduction of scale-up related problems, reduction of time-to-market for newly developed products, more flexibility and agility in manufacturing, as well as drastically reduced lead times and supply chains. Nevertheless, CM is still only in the process of adoption, implementations in industry are rare and there are still hurdles to overcome before the industry will fully embrace CM.
Advanced control strategies and real-time release testing are important challenges. Furthermore, the definition of a batch and the tracking of the material through the system, by a fully-understood residence time distribution, need to be solved by academia, developers and equipment suppliers. Here, modeling and simulation plays an important role.
Prior to now, from a regulatory perspective, no specific guidance for continuous manufacturing exists, although the current framework allows CM submissions and FDA encourages these trends.
To bring CM from R&D to production scale, not only the regulatory uncertainties have to be eliminated, but the economic benefits should be clearly documented. Thus, the aim of the workshop series is to establish guidelines for supporting implementation and submission of CM processes.