GEA helps Janssen Belgium to redefine the future pharmaceutical supply chain with ConsiGma® 4.0 continuous manufacturing solutions
As a pioneer and confirmed advocate of the pharmaceutical industry’s FDA-endorsed implementation of continuous manufacturing (CM) technologies, GEA was delighted to supply ConsiGma® 4.0 equipment to Janssen Belgium and contribute to their recent recognition with the ISPE Facility of the Year (FOYA) Award in the Process Innovation category.
Whilst evaluating ways to further increase the value of their products and processes, Janssen realized that they were reaching the operational limits of their batch manufacturing technologies. As a result, the company embarked on a strategically ambitious project to implement an end-to-end CM line.
Comprising both wet and dry granulation plus continuous direct compression, the Mirror-1 Continuous Manufacturing Platform in Beerse, Belgium, will provide a higher level of operational excellence, built-in quality control and will accelerate the introduction of new and improved medicines.
“Continuous manufacturing represents a significant advance in process innovation and a huge step forward towards more robust manufacturing, decreased material use, regulatory compliance and higher efficiencies during research, development and commercial production,” said Richard Steiner, Global Sales Director, Continuous Technologies.
“Plus, with a PAT-enabled ConsiGma® continuous process, more than 100 independent data points are generated from a variety of sensors and probes, every second, providing a wealth of operational updates. This significant volume of information enables the greater pharmaceutical industry to develop more advanced processes, gain a deeper level of understanding of the parameters involved and, ultimately, make better products in a more cost- and time-efficient way,” he added.
“Requiring cross-functional interaction at all levels, this ambitious project and the implementation of this CM solution will enable patients worldwide to access safer and more affordable products,” commented a Janssen company spokesperson: “Furthermore, the unique advantages of introducing an end-to-end platform will help us to develop novel products that would not otherwise be possible.”
Mirror-1 incorporates and integrates three different process technologies: direct compression, roller compaction and twin-screw wet granulation. The dry and wet granulation portions of the equipment share a joint continuous feeder/blender platform and a second continuous feeder/blender is integrated with the tablet press for either direct compression processes or functions as the downstream portion of the wet/dry granulation equipment. To effectively combine these different processes required intense collaboration with multiple equipment vendors, including GEA, but ultimately enables one platform to respond to the needs of Janssen’s entire oral solid dosage (OSD) form portfolio.
Committed to engineering for a better world, GEA sincerely congratulates Janssen Belgium for completing such an ambitious, forward-thinking project and making an important contribution to the current and future production of high quality oral solid dosage forms.
“This award is reminiscent of our previous collaboration with GlaxoSmithKline (GSK), Pfizer and G-CON Manufacturing to develop self-contained, POD-based mini-factories to produce pharmaceutical OSD forms,” noted Richard: “The resulting portable, continuous, miniature and modular (PCMM) unit, which was subsequently implemented at Pfizer’s labs in Groton (Connecticut, USA), also won a 2016 FOYA for Equipment Innovation.”
Innovations such as PCMM, combined with the ongoing adoption and widespread use of continuous manufacturing technologies, have underpinned GEA’s mission to simplify and expedite the process of accessing and implementing these game-changing solutions. No matter what the scale or throughput of your line or facility, our ConsiGma® 4.0 portfolio — available from standalone bin-2-bin suites to fully integrated production lines — is taking the perceived complexity out of #goingconti and making continuous processing available to everyone.”