RCPE’s ConsiGma™ CTL 25 Line is celebrating its first anniversary!
Over the past 12 months the researchers of RCPE have been working with multiple, large pharmaceutical companies on their ConsiGma™ CTL 25 line, gaining experience and expertise on the CM processes.
RCPE assists its partners by helping them to troubleshoot the issues that occur in the line and identifying the best solution for their application, knowing how the single units interact, where and why problems arise, and how to overcome them.
The need for faster product development, reduced manufacturing footprint, more flexible supply chain, safer and more cost-effective production, drives drug manufacturers to optimise their manufacturing processes. However, very few companies understand how to implement a fully integrated system, with embedded process control.
Thanks to a strategic partnership with GEA and our ConsiGma™ CTL 25 line, we now have a deep understanding of CM processes: we know how the single units interact, where and why problems arise, and how to overcome them.
As an independent centre for pharmaceutical engineering science, we focus on fundamental science. Our CEO Prof. Khinast explains: “Our goal is to fully understand conti-processes from every angle. Nothing should be left to chance – and our vehicle is deep science. In doing so, we help companies to develop their processes – yet much better and faster”.
Leveraging RCPE’s material science, formulation and simulation expertise, our line can be used as a training platform to explore novel technologies (process equipment or sensors) and as a testbed for product feasibility and POC trials. We assist our partners in their formulation development and process setup, control strategy selection and robustness testing. We help them to troubleshoot the issues that occur in the line and identify the best solution for their application.
In this first year of operation, we have generated data to support our industrial partners in their dialogue with the FDA regarding their process and product filing. We’ve also conducted tailored continuous granulations experiments to help excipient suppliers to understand the application and specific benefits of their products.
This is just the beginning. Following the success of our recent ECCPM Forum, we are looking forward to new, interesting and scientifically challenging collaborations, not only utilising our ConsiGma™ CTL 25 line.
Our research and development capabilities also extend to our continuous direct compression and hot melt extrusion lines. Furthermore, our expertise in this area is enhanced by our comprehensive material characterisation and analytical lab services, our multi-domain XPS simulation platform, as well as innovative PAT solutions such as OSeeT (http://www.phyllon.at), a unique product development and in-line coating quality monitoring system. Please visit our website for more information: http://www.rcpe.at.
To learn more about the ECCPM Consortium and its ongoing projects, visit http://www.eccpm.com.
Continuous Manufacturing, Continuous Pharmaceutical Manufacturing, Pharma, Going Conti, Consigma
RCPE is a non-profit oriented, private company in property of TU Graz (65%), University of Graz (20%) and JOANNEUM RESEARCH (15%).
RCPE is a COMET Centre within the COMET – Competence Centres for Excellent Technologies Programme. The COMET Programme is operated by the Austrian Research Promotion Agency (FFG) on behalf of the Federal Ministry for Transport, Innovation and Technology (BMVIT) and the Federal Ministry for Digital and Economic Affairs (BMDW). Our projects are also funded by Land Steiermark and the Styrian Business Development Agency (SFG).
RCPE GmbH, 8010 Graz, Inffeldgasse 13
Lisa Lepori, Head of Marketing & Public Relations
firstname.lastname@example.org, mobile: +43 664 88418860