Dan Watts is on a crusade. The New Jersey Institute of Technology (NJIT) research professor would like the pharmaceutical industry to adopt safer, greener, more efficient and more effective manufacturing processes. Watts, executive director of the Otto H. York Center for Environmental Engineering and Science at NJIT and Panasonic Endowed Chair of Sustainability, is no renegade. Many researchers at the US Food and Drug Administration and other federal agencies strongly support his view.
Big pharma’s greatest challenge, they explain, is finding a means to implement more continuous real-time analytical tracking of chemical reactions and drug formulation operations. And, just how do such changes come about?
According to Watts, companies would need to adopt a highly-effective quality control method, known among chemists as process analytical chemistry. “Analytical chemistry is the chemical science of detecting and measuring the presences of specific compounds,” Watts added. “Process analytical chemistry is focused on carrying out these measurements as quickly and accurately as possible while reactions or other changes are occurring. Knowing when a reaction is complete, for example, allows a change in conditions in time to minimize the formation of impurities in the reaction product.”
Should this come about, the rewards would be great. “If the drug manufacturers adopt such methods, continued high-quality and better-performing pharmaceutical products are bound to result,” said Watts. “The whole manufacturing process would become more effective and efficient. Companies would save money, time and energy, plus reduce environmental problems.”
Watts noted that the industry is not adverse to changes. “There is a will in the industry to make this happen,” he said. “The hurdles of broader implementation come from a need for more rugged and robust instrumentation and regulatory issues resulting from a transition from the current operating practices to a newer one. The industry wants to maintain the flow and supply of necessary new drugs so changes must be implemented slowly.”
Last week Watts brought his crusade down to the grass roots level. With funding from the National Science Foundation and help from the Center for Workshops in Chemical Sciences at Georgia State University, Watts and NJIT colleagues Somenath Mitra, PhD, professor and chair of the department of chemistry and environmental sciences, and Piero M. Armenante, PhD, distinguished professor of chemical engineering and director of the graduate program in pharmaceutical engineering at NJIT, ran a five-day workshop. Sixteen faculty from universities around the nation worked to develop ways to encourage their students to pursue careers in the pharmaceutical industry so this new way of thinking can flourish.
“Our biggest challenge has been,” said Watts, “to inform and excite undergraduate students. We think that a workshop such as this one gets the message across to the teachers to bring about such changes.”
Workshop topics included ways to develop a more robust use of on-line or real-time analytical techniques to give more control over processes. “If this could be achieved,” said Watts, “fewer failures would occur resulting in a reduced negative environmental impact.”
In addition to attending seminars and classes at NJIT, workshop participants visited the research and manufacturing facilities at Johnson and Johnson Pharmaceutical Research and Development in Raritan and Merck in Rahway. The workshop is part of a program sponsored by the National Science Foundation through the Center for Workshops in Chemical Sciences at Georgia State University.
NJIT programs and resources in sustainable green manufacturing, pharmaceutical engineering and research in innovative methods for rapid chemical analysis were used to develop the workshop.