Pharma faces growing challenges due to the rising costs of materials, demand for specialized medicine, and slow manufacturing processes that could lead to more significant inventory shortages.
Traditional pharmaceutical manufacturing processes, referred to as ‘batch manufacturing’, are decades-old, slow processes that can take months for manufacturing steps in different geographic locations. The costs of switching from batch manufacturing to continuous manufacturing facilities are expensive, but the rewards could greatly benefit everyone.
Janssen was the first to switch over from batch, gaining FDA approval for its HIV drug Prezista. Vertex followed by starting continuous manufacturing with its drug for Cystic Fibrosis, Orkambi. Lawrence Yu, the FDA Deputy Director for the Office of Quality in Pharmaceuticals, sees continuous manufacturing as a way to not only produce drugs faster and cheaper, but with better quality. Yu said, “By eliminating breaks between steps and reducing opportunities for human errors during the stops and starts in the batch process, continuous manufacturing is more reliable--and safer. That’s a powerful combination.”
So what exactly is pharma continuous manufacturing and why are FDA members urging pharmaceuticals to transform? Let’s look at Batch versus Continuous Manufacturing.
Batch manufacturing involves multiple steps in the process that requires halting after each step for quality testing or movement of material. This includes storing of perishable material and shipping material to other global facilities, adding months to the processing time. Furthermore, variable sizes of equipment need to be switched in the event of a surge in demand. This inhibits the process from functioning at optimal efficiency by wasting time, money, storage, and logistical energy. Not to mention, increasing the volume of wasted product also has a negative effect on the environment. The constant switching of equipment results in the product quantity being defined by the size of the equipment that produced the material. This resistance to flexibility leads to higher volumes of defective material.
Continuous manufacturing ensures the least amount of wasted time, money, and material. Materials have no wait time, and are not shipped in between halts in the process. Continuous manufacturing utilizes an assembly line process with integrated components created to process the material immediately. This enables a more efficient, responsive-to-market system that mitigates the likelihood of human error and allows production to continue for longer durations of time.
Automated monitoring is used in continuous manufacturing to make frequent, routine checks, and predict issues before they result in the failure of a machine. This enables maintenance employees to know what equipment needs attention and exactly when. Assistance from automated monitoring and machine processing is another phenomenal time saver as pharma companies can begin to be predictive rather than preventative. Product quantity as a continuous manufacturer can be defined by timestamp, amount of material produced, or the amount of material used. This is significantly more beneficial than batch manufacturing because it allows more accurate tracking of product flow, enabling quality control to pinpoint and isolate the exact defective material.
Despite all the benefits of continuous manufacturing, pharma organizations are still hesitant to transition. A few reasons include lack of knowledge in digital transformation, fear of extravagant spending on solutions that might not yield better results in the short-term, and fear that the long-term benefits could be too far away. The common themes are high start-up costs - like replacing batch equipment, training staff, and revamping infrastructure - but the biggest challenge is continuous manufacturing technologies need to become mature before being commercially viable in some products. Large molecule biologics may not be applicable for continuous manufacturing.
Pharma companies fear making investments in manufacturing knowing digital transformation could be very impactful to their bottom line. Research and development are already yielding a meager return on investment, so negatively impacting slim manufacturing margins is not ideal.
The most efficient way to solve manufacturing inefficiencies is to collaborate through centers of excellence that consist of academic research facilities, technology partners, and drug manufacturing leaders. Competition should not be amongst our pharma companies, it should be against the fatal diseases stealing loved ones and hurting our quality of life. The New Jersey Innovation Institute (NJII) has teamed up with the Innovative Manufacturing Medicine Institute to develop the New Jersey Continuous Manufacturing Institute (NJCMI). The NJCMI is a forerunner for the progression of pharmaceutical production by combining the expertise, technology, and infrastructure of the industry to catalyze the shift to smarter pharmaceutical operations. NJII is poised to offer product development expertise to bridge the gap between the biotech startup culture and traditional pharmaceutical companies. Perhaps they will find a hybrid approach between batch and continuous manufacturing that could make the transition less costly.
Continuous manufacturing will incorporate development for real-time, event-driven orchestration where the physical meets the digital that will need to scale to handle continuous streams of data across machines, systems, and people. Real-time, event-driven platforms like VANTIQ can serve as the central nervous system for the continuous manufacturing infrastructure. Not only can such platforms sense and analyze real-time insights from physical and digital, but it can act to ensure the quality of active pharmaceutical ingredients in products is not compromised.
Building continuous manufacturing processes will require software to connect all equipment and conduct measurements to yield the best results by taking appropriate actions in real time. Only rapid development, low-code platforms like VANTIQ will allow pharma to build applications in a few days’ time, and then change quickly as new processes are needed. The alternative would be to code software applications that could take months, handcuff process improvement, and hinder product innovation. Pharmaceutical digital transformation will usher significant changes to technology, people, and processes - including continuous manufacturing. The rewards will include lower prices, higher margins, fewer inventory shortages, better efficacy in our drugs, and ultimately healthier, happier people.
Chris Ganacoplos is the Director Northeast Sales at VANTIQ and has many years experience helping customers in the pharmaceuticals sector to understand how to improve processes through technology.
Chris Esposito is the Marketing Associate at VANTIQ. A recent Belmont University graduate, Eagle Scout, and creative, Chris is intrigued by new trends in the world that affect technology, ecology, and artistry.