03 - 04 December, 2019
Steigenberger Frankfurter Hof, Frankfurt
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How the CPI, GlaxoSmithKline, and AstraZeneca are Collaborating to Establish a Continuous Wet Granulation Manufacturing Facility
Pharma manufacturing is changing, of that there is little doubt. From the introduction of Industry 4.0 technology to new and more efficient processes and the rise of personalised medicines, there is no longer a one size fits all solution when it comes to making life-saving treatments.
When it comes to innovating in this field it can often become necessary for competing brands to work together. It’s not unusual for these companies to pool their resources when it comes to investing in new technology, building contemporary infrastructure, or developing new processes.
CPI, GSK, and AstraZeneca
The new facility has been developed to create a way for these big brands to develop small-scale oral solid dosage pharmaceuticals. The overarching goal is to meet the demands of the modern pharma industry by reducing time to market and removing the need for the testing of products at the end of the manufacturing cycle – a process which is incredibly labour and time intensive.
The facility will come complete with the latest in Industry 4.0 technology with connected IoT machines able to communicate with one another and feed back to central servers where data scientists will be able to constantly monitor their performance and be quickly alerted to any problems which may be arising – preventing long-term shut downs. Integrated in-line process analytical technologies will include blending and feeding of raw materials and the beginning of the manufacturing process, twin screw wet granulation, drying, and at the end of process pressing the finished product into tablets.
It will also serve as, not only a fully operational manufacturing facility, but an open innovation centre. The innovations developed in the centre will be deployed to support the UK pharmaceutical industry as well as other industries which have the manufacture of controlled and complex solid forms at their core.
“GSK is proud to be working with CPI to develop the PROSPECT CP platform,” said Director for Drug Product Design and Development at GSK, Jason Crooks. “The work progressed on PROSPECT CP over the next two years will provide a much-needed springboard to accelerate incubation and translation of emerging process analytical technologies to the pharma business.”
While rising development costs, the requirement for faster times to market and the growth of production, have contributed to the need to improve efficiency across the pharmaceutical life cycle, and thus driven the need for continuous manufacturing, there is still a need for traditional processes.
Batch production is still the dominant force in pharma manufacturing due to its well-established benefits. When you manufacture discrete batches, it is easier to isolate issues and address them before the next batch goes into production. The established and strict regulations around batch manufacturing also make it more difficult for bad practices to develop. However, batch production can often be inefficient, make it easy for products to emerge out of specification, and for variability to creep in.
Continuous manufacturing by comparison can be scaled more simply, has lower labour requirements, and requires a smaller capital investment. Because manufacture is continuous, once the parameters have been set and all ingredients mixed simultaneously, variation in production can be all but eliminated.
However, continuous manufacturing requires its own set of considerations when brands are deciding whether to implement it or not.
“Biopharma companies aren't making decisions about manufacturing in a vacuum, though,” reports BioPharma Dive. “For all the advantages of continuous manufacturing over batch production, drug makers must weigh switching over against retooling carefully crafted production networks. Large multinational pharmaceuticals companies already have an expansive base of manufacturing facilities, with supply chains stretching across borders. With production up and running, taking on the cost of adopting continuous manufacturing may not make sense for products already on market.”
However, with massive brands such as GSK and AstraZeneca teaming up with industry heavyweights like the CPI, they can work to develop these processes and the technology which underpins them and make continuous manufacturing more efficient, reliable, and cost effective than ever.
Continuous manufacturing could potentially be the future of pharma manufacturing, but it remains to be seen whether it will completely replace traditional batch manufacturing.
“Since the 2000s, the industry has steadily moved away from the mass-market pills that previously supported many drug maker bottom lines,” concludes BioPharma Dive. “Increasingly, biotechs and pharmas are focused on more expensive biologic drugs, which are made from biological material and are costlier to produce. Emergence of cell and gene therapy has further upped the importance of improving manufacturing capabilities.”
Continuous manufacturing is set to be a hot topic at ManuPharma 2019, being held in December, at the Steigenberger Frankfurter Hof, Frankfurt.
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