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 specialises 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 optimisation.
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 customised quantities of drugs to patients in need in a quick and efficient way.”
During the upcoming ACHEMA trade show, taking place in Frankfurt, Germany, GEA will hold a press conference on Tuesday 12 June at 11:00 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.