Continuous pharmaceutical manufacturing is no longer a niche trend. It’s already happening. Although implementation and knowledge transfer can be time consuming, early adopters are embarking on a new trajectory of business excellence, benefiting from numerous competitive advantages and staying ahead of the market.
Despite its much-deserved hype, continuous processing in the pharmaceutical industry is not an entirely new concept. For many years, technologies such as spray drying, dry blending, granulation and extrusion, to name a few, have been recognized as continuous operations. For decades, if not longer, even the humble tablet press has functioned in a continuous way. Until recently, however, because of regulatory restrictions and the fact that powder was delivered to the press — and the preceding unit operations — in batches, they have mainly been used in batch mode.
At first glance, #goingconti could be viewed as a simple link between unit operations, resulting in a “powder to coated tablet” process flow. Looking more closely, though, early adopters, system integrators and regulatory agencies have identified that this “logic” link is far more complex and offers benefits such as faster product development, reduced costs and increased manufacturing flexibility.
GEA has been pioneering continuous manufacturing (CM) solutions for the past 16 years and helping customers to develop, evaluate and optimize continuous processing techniques to enable them to bring new products to market faster and cheaper. Providing higher yields, lower utility consumption and reduced waste, CM is enabling drug makers to move away from stepwise and time-consuming batch processing to a fully integrated and closely controlled process that gives excellent product consistency by intrinsic design.
Now, increasingly gaining momentum in the drug manufacturing sector as the new normal approach to oral solid dosage (OSD) form production, CM can help to transform today’s pharmaceutical business processes into a future market environment driven by global megatrends, such as ageing populations, growing middle classes in emerging markets, increased patient safety, cost reductions in public and private healthcare and increased regulations.
Beyond its proprietary and multipurpose ConsiGma® 4.0 platform — designed to transfer powder into coated tablets in development, pilot, clinical and production volumes — GEA has taken a proactive stance in the market and spearheaded several collaborations and partnerships that have flown the metaphorical flag for #TheContiTruth to highlight its many advantages.
Working with GSK, Pfizer, GEA and G-Con Manufacturing, for example, A consortium designed and built a portable, autonomous manufacturing environment for continuous OSD production using GEA’s ConsiGma® system and G-CON's modular POD system. Presented with the award for Best Technologies Innovation during INTERPHEX 2015 and subsequently receiving an ISPE FOYA for Equipment Innovation, this first-of-a-kind portable, continuous, miniature and modular (PCMM) system accelerates the speed at which tablets are produced.
By miniaturizing the equipment, the continuous process can be enclosed in small-footprint modular facility, which can be shipped by truck to any location in the world and quickly assembled. Once up and running, the system has the capability to transform powders into uncoated tablets in minutes, which can take days or weeks with current technology.
Also in 2015, for the first time, the US FDA approved a pharmaceutical oral solid dosage form (ORKAMBI, Vertex Pharmaceuticals Incorporated) that had been developed and produced using GEA’s ConsiGma® continuous manufacturing platform. Commenting on the announcement at the time, a GEA spokesperson said: “This has been an interesting and challenging journey, but we are extremely pleased that this new production technology has been successfully validated and sanctioned for commercial production, specifically for an important new breakthrough therapy.”
More recently, whilst evaluating ways to further increase the value of their products and processes, Janssen Belgium 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. “Requiring cross-functional interaction at all levels, this ambitious project and the implementation of this CM solution with ConsiGma® equipment 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.” What’s more, for their aspirational approach to advancing CM, Janssen received the 2020 FOYA in the Process Innovation category.
To view a movie about this project, follow this link to Youtube.
GEA and forward-thinking companies such as these are keen supporters and drivers of this innovative manufacturing technology. And whereas many companies talk about continuous manufacturing, these GEA customers have actually implemented it and are benefiting from the advantages it offers. Supported by the US FDA and approved for the development and production of novel oral solid dosage forms, CM is not just a concept; it’s real and already delivering on its promises.