Advancing the Pharmaceutical Supply Chain
Mauricio Futran, vice president, Process Sciences, Janssen Supply Chain, discusses, in the latest issue of Pharmafile, Janssen’s move into continuous production and the benefits attained through the move.
Over the last 50 years, there have been incredible breakthroughs in the treatment of disease thanks to pharmaceutical innovation – combat and eradication of infectious diseases via vaccinations, the advance of biologic therapies that have changed how autoimmune diseases are treated, new therapeutic agents that have made previously fatal cancers more manageable, and development of anti-viral therapy for HIV. However, the same rate of change has not impacted how these pharmaceuticals are manufactured.
While other industries ranging from automobiles to telecommunications have enhanced their processes to utilize the latest technological capabilities, traditional “batch” manufacturing – where pills or products are created in a step-by-step process that can take weeks and span multiple production facilities – remains the norm. At Janssen, we believe that as the pharmaceutical and biotechnology industry and market evolve, so should our manufacturing sites and processes in order to accelerate our ability to meet customer needs.
In 2015, Janet Woodcock, Director of the U.S. Food & Drug Administration Center for Drug Evaluation & Research (CDER) spoke publicly in front of Congress espousing the values of the pharmaceutical industry implementing “continuous” manufacturing technology into their production lines. This new approach enables much faster production and more reliable products through an uninterrupted process. The benefits of continuous manufacturing over traditional batch manufacturing are wide-ranging: incorporation of real-time release testing and process analytical technology, a reduction in waste, footprint, environmental impact and active pharmaceutical ingredient (API) consumption, and increased safety due to no manual handling of raw materials.
While there are substantial costs and considerations to transitioning from “tried and true” processes that are used in global pharmaceutical manufacturing facilities, at Janssen we are proud to be blazing the trail in the pharma industry with continuous manufacturing. Over the last several years, Janssen Supply Chain has been partnering with Rutgers University Engineering Research Center for Structured Organic Particulate Systems (C-SOPS, a leading academic research facility for continuous manufacturing) and the University of Puerto Rico on a complex technology for continuous manufacturing that integrates all manufacturing steps (weighing, milling, blending, compression & coating) into one line. Continuous manufacturing can reduce testing-to-release time from 30 days to a target of 10 days by integrating technology-enabled real-time release testing throughout the control process for critical quality attributes.
Earlier this year, we became the first company to receive FDA approval to change over from batch to continuous manufacturing for an approved product (PREZISTA [darunavir] 600 mg tablets, for the treatment of HIV). By incorporating state-of-the-art continuous production technology, we have been able to produce a high quality product while meeting the FDA’s challenge to accelerate the delivery of innovative therapies for patients. The new process, implemented at our Gurabo, Puerto Rico facility, was a first for the industry, but is just the beginning for us. Through our collaboration with academia, we can provide science-based data to the FDA and other regulatory agencies to improve the way pharmaceutical products are manufactured.
Looking to the future, we are investigating continuous manufacturing in drug development on the R&D side and potential application in biologics manufacturing, which could lead to reduced scale-up time and, eventually, shorter time-to-market. We aim to manufacture up to 70 percent of our solid oral dosage form products using continuous manufacturing within eight years, increasing yield by reducing waste by 33 percent, and reducing manufacturing and testing cycle times by 80 percent. A commitment to innovation at all levels of the pharmaceutical process drives us at Janssen. Our Supply Chain team, in collaboration with our Regulatory Affairs partners, is proud to be doing our part to ensure quality treatments get into the hands of patients and physicians safely and efficiently, as we do our part to support the next 50 years of pharmaceutical advancement.
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental …
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