By Ken Congdon
Janssen Supply Chain, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), has a long-standing collaborative partnership with the Rutgers University School of Engineering when it comes to continuous manufacturing. The partnership began more than five years ago when Janssen became one of the founding members of the Rutgers Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) — the world’s largest academic-based research organization dedicated to modernizing pharmaceutical manufacturing of solid oral dose medications. Janssen, the National Science Foundation, and a consortium of more than 40 other companies within the pharmaceutical sector provide the funding for the Center, whose primary focus is the technical development and advancement of continuous pharmaceutical processing.
As part of this collaboration, Rutgers engineers designed and built one of the first full production-scale continuous direct compression solid oral dosage manufacturing facilities — a facility that has recently been expanded to include wet and dry granulated products. This line, located on the Rutgers Engineering School campus in Piscataway, NJ, is used to test multiple continuous manufacturing production routes and processes in an effort to optimize automation, control, and product design.
Rutgers Research Facility Proves Continuous Manufacturing Concepts
|“The shared commitment Janssen and other pharmaceutical companies have with Rutgers to advance pharmaceutical manufacturing technology, enhance our collective efficiency, and modernize industry processes is helping to accelerate positive change,” - Mauricio Futran, VP of Advanced Technology for Janssen Manufacturing and Technical Operations.|
The tests performed on the Rutgers line have proved instrumental in driving and shaping Janssen’s own continuous manufacturing efforts. “While other industries have been leveraging continuous manufacturing for several years, pharmaceutical companies have been slow to adopt these processes,” says Mauricio Futran, VP of Advanced Technology for Janssen Manufacturing and Technical Operations. “The regulatory environment that exists in the pharma sector is one reason for the sluggish pace of adoption, but the technical challenges that exist in pharma are also a huge issue. For example, other industries that use continuous manufacturing don’t handle powders or solids. The technology and processes needed to manufacture pharma products in a continuous fashion needed to be developed and demonstrated.”
In response, Rutgers has been researching a wide variety of areas, including powder processing and materials properties, process modeling and control, and in-line process analytical technology on its line in an effort to design and implement robust, reliable, and consistent manufacturing processes that meet regulated quality standards at a lower cost.
“Through tests performed at the Rutgers facility, we saw the technology mature to the point where we believed it could be commercialized,” adds Futran. “Specifically, we saw that each of the continuous steps could be controlled and integrated in pharmaceutical setting. We used this information to turn the concept into reality at Janssen.”
The “reality” Futran is referring to is the continuous manufacturing line Janssen recently built in Puerto Rico, using the Rutgers facility as a model. This line is currently up and running and, according to Futran, Janssen is only a few months away from performing a validation of Prezista (an HIV/AIDS medication) on this line and filing it with the FDA.
Futran admits that a successful continuous manufacturing transformation involves much more than a technology proof-of-concept. It requires a focused effort on internal change management as well. To this end, Janssen has been heavily involved in educating its staff — particularly the line operators, engineers, quality personnel, and regulatory executives — on the elements of controlling a continuous manufacturing process as opposed to the traditional batch method. As part of its partnership, Rutgers School of Engineering personnel is assisting in the continuous manufacturing training efforts of Janssen employees.
Visualizing The Benefits Of Continuous Manufacturing In Pharma
The continuous manufacturing tests and research performed at the Rutgers facility did more than provide Janssen with a blueprint for how to build its own line, it also provided the company with some detailed insight into the measurable benefits it can expect from continuous manufacturing once deployed on a larger scale. Most notably, with the integration of continuous manufacturing, Janssen and J&J aim to manufacture 70 percent of its highest-volume products using continuous processing within eight years, increase yield by reducing waste by 33 percent, and reduce manufacturing and testing cycle time by 80 percent. These and other benefits are outlined in this continuous manufacturing infographic.
Furthermore, Janssen is also contemplating the use of continuous manufacturing in drug development on the R&D side as well as applications in biologics manufacturing. According to Futran, this effort could drastically reduce scale-up time and accelerate time-to-market.
There’s no question that Janssen’s strategic collaboration with Rutgers School of Engineering has been fruitful to date. Therefore, it’s no wonder that the company furthered its partnership with the school last month by providing additional funds in excess of $6 million to support the research and development efforts at the Center over the next several years. As part of this latest agreement, Rutgers will conduct research in an effort to help Janssen produce more J&J products on a continuous manufacturing line. According to Futran, this effort includes a lot of engineering analysis, mathematical modeling, and automation enhancements.
“The shared commitment Janssen and other pharmaceutical companies have with Rutgers to advance pharmaceutical manufacturing technology, enhance our collective efficiency, and modernize industry processes is helping to accelerate positive change,” says Futran. “We look forward to investing further in continuous manufacturing and transforming our production efforts as a result of this powerful partnership.”