GEA and Perceptive Engineering, Daresbury, UK, have announced a collaboration to promote and deploy cutting-edge multivariate monitoring and Advanced Process Control (APC) solutions for batch and continuous pharmaceutical process units.The partnership will further enhance GEA’s ConsiGma® platform for oral solid dose (OSD) pharmaceutical development and manufacturing by offering “out of the box” APC and monitoring capabilities. The continuous monitoring of product quality can prevent out-of-specification deviations and decrease production costs, as well as reducing final quality inspections by facilitating real-time release testing.
The ConsiGma® continuous tableting line is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single compact unit. The system can perform dosing and mixing of raw materials, wet or dry granulation, drying, tableting, coating and quality control, all in one line. From powder to coated tablet, ConsiGma® allows pharmaceutical companies to continuously process and manufacture oral solid dosage forms. Offering significant reductions in development time and raw material (API) use, process and energy costs can be considerably decreased using this groundbreaking technology while maintaining quality and increasing manufacturing efficiency. Headquartered in northwest UK, Perceptive Engineering specializes in the deployment of model-based APC, especially within the pharmaceutical sector. Perceptive’s PharmaMV™ platform provides modular tools to design, deploy and maintain advanced applications within a regulated environment.
The partnership builds on the successful implementation of Perceptive’s APC platform into the first-generation PCMM (portable, continuous, miniature and modular) platform for the development and production of pharmaceutical OSDs. Originally conceived in conjunction with Pfizer and G-CON, the three companies formed a consortium to design and build a portable, autonomous manufacturing environment for continuous OSD production using GEA’s ConsiGma® 25 equipment and G-CON's modular POD system. A prototype unit is currently being implemented at Pfizer’s labs in Groton (Connecticut, USA).
This collaboration also builds on the previously announced relationship between GEA and Siemens, as well as the existing association between Siemens and Perceptive. Together, this provides a leading-edge, industrially proven solution for pharmaceutical manufacturers, comprising both hardware and software platforms, as well as PAT integration, process monitoring, process analytics, control and optimization. This complete, seamless suite is designed to help pharma companies exploit the opportunities presented by moving to continuous manufacturing.
Commenting on the announcement, GEA’s Phillip Gabb, Head of Solid Dosage Sales Support, said: “With collaborations such as this one, GEA and its partners are leading the way toward smaller, more flexible continuous processing technologies that have the potential to transform the future of pharmaceutical development and manufacturing — and deliver customized quantities of drugs to patients in need in a quick and efficient way.”
GEA press-conference at ACHEMA on June 12, 2018
During the upcoming ACHEMA trade show, taking place in Frankfurt, Germany, GEA will hold a press conference on Tuesday 12 June at 11 AM in Hall 4.0 (stand F46) to announce a number of industry collaborations that will help to facilitate the uptake of continuous manufacturing technology in the drug production sector.
We are actively building collaborative partnerships with providers of complementary technologies and solutions, which are not within GEA’s scope of supply, to deliver the services and infrastructure our customers need to be able to implement continuous manufacturing, noted Phil.
About Perceptive Engineering’s Technology
Perceptive Engineering creates engineering solutions using model-based control and monitoring technologies. Their PharmaMVTM software platform is specifically designed to support development and deployment of multivariable technologies within the regulated pharmaceutical production environment. It uses a digital model of the process plant to assist with operational decisions. Running the model “live,” in parallel with the process, is designed to verify the process continues to operate at an optimum efficiency.
PharmaMV™ detects differences between the model and the process; these are highlighted to control room personnel and used within a control system to regulate the process. These systems also provide early warning of any developing faults, within the process, equipment and analytical devices, thereby forming an integral part of a Continuous Process Verification (CPV) system.
PharmaMV can be embedded within GEA’s automation infrastructure to provide a seamless environment for control room personnel. The APC methods are controlled by the process recipe management system with embedded multivariate visualization tools and CPV reports provided.