Purdue University is known as a leader in aeronautics and engineering, but did you know that the university also has cutting edge technology for pharmaceutical manufacturing? The Food and Drug Administration attended a week-long training program at Purdue in August where employees gained experience with the new, more streamlined process for manufacturing drugs.

At Purdue, students can learn about advanced manufacturing processes used by the pharmaceutical industry in new treatments for HIV, cancer and leukemia. The university is only one of two in the country with a continuous manufacturing pilot plant of pharmaceutical solid-dosage forms, said Marcial Gonzalez, training program leader and Associate Professor of Mechanical Engineering.

“The FDA recognizes they should be training inspectors and reviewers so they can judge a new drug application using these advanced manufacturing processes and see if the industry has implemented them correctly,” he said.

The all-day sessions at Purdue’s Flex Lab helped the FDA learn to better inspect and review the manufacturing of new drugs entering the market. Nineteen FDA employees participated in hands-on lab training and modeling-oriented sessions created by Purdue’s training team. They also observed case studies on how to execute the continuous tableting process. “We’re closing the loop and sharing what we’ve done over the years with the entity that regulates the industry,” Gonzalez said.

The training took place at Purdue University’s Continuous Solids Processing Pilot Plant and Particle, Powder, and Compact Characterization Laboratory. The lab is located at the Center for Particulate Products and Processes (CP3) , where students can study, design, and manufacture pharmaceutical tablets and other particulate products on an industrial scale.

The Purdue training group -- which included a research scientist and undergraduate, graduate and post-doctoral students -- enjoyed training the FDA employees and hearing their perspective. Other professors involved in the training were: Paul Mort (Professor of Materials Engineering), Zoltan Nagy (Arvind Varma Professor of Chemical Engineering), and Rex Reklaitis (Burton and Kathryn Gedge Distinguished Professor of Chemical Engineering). “We like the fact that the (FDA) group was very diverse,” said Gonzalez, referring to the group’s career experience and educational background. “It was a phenomenal experience for the students involved.”

Muhammad Shahab, a Purdue postdoctoral scholar, works on the roller compactor on the second level of the modular pilot plant during a week-long training program in August for FDA employees at Purdue’s Flex Lab.

Shumaiya Ferdoush, a Purdue postdoctoral scholar, works with gravimetric feeders on the third level of the modular pilot plant during a week-long training program in August for FDA employees at Purdue’s Flex Lab.

David Sixon, an undergraduate student (pictured far right), and Dalton Yu, a graduate student (pictured on far left), appear on the second level of the pilot plant with FDA employees who attended a week-long training program in August at Purdue’s Flex Lab.

Purdue University is only one of two universities in the country with a continuous manufacturing pilot plant of pharmaceutical solid-dosage forms. The university hosted a week-long training program in August for Food and Drug Administration employees at Purdue’s Flex Lab.

Employees from the Food and Drug Administration attended a week-long training program in August at Purdue University where they gained experience with the new, more streamlined process for manufacturing drugs. The university is only one of two in the country with a continuous manufacturing pilot plant of pharmaceutical solid-dosage forms, said Marcial Gonzalez, training program leader and Associate Professor of Mechanical Engineering.