Paving the Way for Continuous Oral Solid Dosage Production
(PRWEB) May 20, 2015 -- According to Charles Darwin’s famous quote, it’s not the strongest or the most intelligent that survive, but those who can best manage change. And when it comes to managing changes in demand for innovative pharmaceutical manufacturing technologies, GEA Pharma Systems has made significant evolutionary steps forward.
Many pharmaceutical companies still rely on traditional batch manufacturing processes to produce drugs. In the absence of major developments in operating principles and equipment design, batch-based systems have performed perfectly well and continue to do so. To avoid regulatory issues, the industry has been keen to maintain the status quo and, when increased outputs were required, it was simply a matter of increasing the batch size.
Now, however, slightly less risk averse and keen to improve both supply chain efficiency and product throughput, the pharmaceutical industry has recognised that continuous manufacturing (CM) solutions can accelerate product development, reduce costs, improve production economics and increase manufacturing flexibility.
CM is generally considered to be more efficient and to consistently deliver a higher quality product. As Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), noted: “A number of companies are on the verge of adopting continuous manufacturing and other advanced manufacturing techniques, which are not susceptible to many of the problems of traditional manufacturing models. CM can transpire in a single small room, starting with raw materials at one end and finishing with tablets on the other.” In fact, six of the top ten pharmaceutical companies have now confirmed that, by 2020, all new chemical entities (NCEs) and, whenever possible, legacy products will be produced using continuous technologies.
When Woodcock advised the pharmaceutical industry to get ready for the concept of continuous drug production, GEA was already there. The company has been running a lab-based continuous line since 2007. And, in 2010, GEA expanded its Process Development Center (PDC) in Wommelgem, Belgium, to provide its customers with advanced technology to develop, evaluate and optimise continuous processing techniques and help them to bring new products to market faster and cheaper. With a permanent staff of experienced engineers, GEA offers customer training, product and process development, feasibility trials and more, from equipment selection to process optimisation.
The lab has been upgraded several times since its inception and more than 150 new and existing formulations have been successfully tested. Based on those results, and GEA’s unparalleled industry reputation as a world-class supplier of technology and equipment, more than 40 R&D and production installations have been completed, all over the world (GEA also has a lab in the US and there’s a unit in Japan in which trials can be done). Eight of the top ten pharmaceutical companies have invested in GEA technology and ConsiGma™ installations all over the world, with regulatory approval for commercial production, are currently — and continuously — producing tonnes of tablets.
At the heart of GEA’s fully integrated, powder-to-tablet CM solution is ConsiGma™, a multi-purpose platform that has been designed to transfer powder into finished dosage forms 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. By producing finished dosage forms continuously, batch sizes are determined by how long you run the machine.
SHOW SUCCESS
To highlight its market-leading position in CM, GEA was recently presented with the award for Best Technologies Innovation at this year’s INTERPHEX for its standardised development and manufacturing technology platform: PCMM (Portable, Continuous, Miniature and Modular). Developed 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.
With the development of CM systems said to be one of the most significant changes in the pharmaceutical industry in the next 10 years, a GEA representative commented: “Winning this award is welcome recognition for the effort and innovation that went into PCMM and clearly reflects excellence in pharmaceutical development and manufacturing.”
The pharmaceutical industry is looking at continuous processing to improve production quality in an efficient and cost-effective way and to comply with the increasingly stringent manufacturing acceptance criteria put in place by the regulatory authorities. GEA has, from the very beginning, led the field with flexible development options that facilitate the commercial manufacturing process and enable greater process understanding to be achieved with smaller quantities of material.
With a range of solutions developed according to Six Sigma process guidelines, GEA is an established expert and a single-source solution provider of equipment, technology and know-how for this evolutionary powder-to-tablet manufacturing concept.
Want to learn more? Join GEA Group at the upcoming ACHEMA 2015 trade show (Hall 4, Stand F46) in Frankfurt, Germany (June 15–19, 2015). Showcasing new products and performing live demonstrations throughout the event, visitors will be able to see continuous manufacturing for themselves. GEA’s world-class experts will be running real-time trials with the laboratory scale ConsiGmaTM-1 and a brand new continuous coater, further highlighting the company’s industry position as continuous manufacturing specialists.
Steve Jordan, The Words Workshop Ltd - US, +44 1908 695500, [email protected]
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