GEA Pharma Systems’s second Continuous OSD Development and Production Seminar (4–5 June, Wommelgem, Belgium) enabled new and established users of the ConsiGma™ continuous manufacturing (CM) platform to share their experiences and learn about the latest developments in this innovative technology.
Presentations from Roche and Johnson & Johnson focused on the development of a continuous process, for both new and legacy products, and discussed both the benefits — quicker time-to-market, reduced costs, better process control and improved product quality — and the challenges of CM. Regulatory aspects were addressed in a presentation by Vertex, and Dainippon Sumitomo showed that continuous processing is not just limited to the FDA/EMA-regulated countries but is also of interest in Japan. Globally, customers are investing in CM for a variety of reasons, including higher yields, reformulating legacy products, lower environmental emissions and operational flexibility.
Pfizer, который сотрудничал с GEA и G-Con для разработки концепции PCMM (портативный, непрерывный, миниатюрный и модульный), сосредоточился на гибкости. Делегаты извлекли выгоду из фактического просмотра машины в процессе строительства, что значительно добавило презентации. И, наконец, проблема внедрения и анализа онлайн-измерений была освещена в презентации MSD.
Day two comprised four practical workshops, during which the ConsiGma™ technologies were further explained and demonstrated. The ease and speed of developing a continuous process using Design of Experiments (DoE) was shown in the ConsiGma™-1 workshop, also highlighting the importance of fully understanding product characteristics in development.
In the ConsiGma™ continuous tableting line workshop, the formulation developed with the ConsiGma™-1 was used to demonstrate how easy it is to transfer the R&D parameters to production, highlighting the predictive power of DoE. The remaining workshops showcased the ConsiGma™ continuous coater and the ConsiGma™ continuous direct compression (CDC) line, emphasising how rapidly the continuous market is expanding and underlining GEA Pharma Systems’s position as a leader in the field.
Attracting more than 60 participants from 24 companies, the event was a great success and received extremely positive feedback, with attendees commenting: “Very interesting seminar,” “Very well done,” “Very good and diverse,” and “Great meeting, I’ll definitely recommend it to others.” Consequentially GEA Pharma Systems has announced that in its efforts to inform and educate the pharmaceutical industry about the possibilities and benefits of CM, the seminar will become an annual event.