IMA Active and CONTINUUS Pharmaceuticals at the ECA Academy on Continuous Manufacturing
IMA Active and CONTINUUS Pharmaceuticals are pleased to take part in the ECA Academy on Continuous Manufacturing, which will be held in Barcelona (ES), on November 27-28, 2018.
It is the aim of this conference to show how a transition from batch to Continuous Manufacturing for small molecules can look like. Questions regarding technology, process development and GMP/Quality Assurance and Regulatory Affairs will be discussed.
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. Companies like GSK, Pfizer, Johnson & Johnson and Vertex have been in the news lately. A shift from batch to Continuous Manufacturing could be one of the largest paradigm changes since the system of validation and qualification came up years ago.
Regulatory requirements for continuous processes
FDA’s past, present and future expectations
Advanced process control with PAT
Available equipment & technology
Control strategies in continuous processing
Case study TEVA
Case study GSK
Case study CONTINUUS Pharmaceuticals
Salvatore Mascia, Founder & CEO at CONTINUUS Pharmaceuticals, will held the presentation “Integrated Continuous Manufacturing with novel technologies”.
The development of novel manufacturing technologies has the potential for reaping the full benefits of Continuous Manufacturing. Moreover, their integration into a modular plug-and-play, end-to-end Continuous manufacturing process, including both chemical and pharmaceutical operations, i.e. Integrated Continuous Manufacturing (ICM), can open a new manufacturing paradigm for this industry. The development of an integrated control strategy for ICM is crucial to ensure release of pharmaceutical products that conform to specifications. ICM relies on proven principles of quality by design and the use of process analytical technologies to monitor and control the manufacturing operation. ICM will enable “on-demand” manufacturing of pharmaceuticals: high quality medicines will be produced quickly when needed, and a significantly reduced cost.