URI Pharmaceutical Development Institute hosts Amgen employees for training in biopharmaceutical manufacturing

The College of Pharmacy-affiliated Institute committed to enhancing, expanding capacity and workforce development of pharmaceutical and biotechnology firms

Cahil McGovern instructs an Amgen Inc. employee on proper cGMP
Cahil McGovern (right), manager of operation for the URI Pharmaceutical Development Institute, instructs an Amgen Inc. employee on proper cGMP (certified Good Manufacturing Process) techniques. Photo by Patrick Luce

KINGSTON, R.I. — Dec. 20, 2019 — The URI Pharmaceutical Development Institute continued its mission to enhance the economic development of the region’s pharmaceutical and biotechnology industries and help expand the biopharmaceutical workforce this week, hosting Amgen Inc. employees for training in biopharmaceutical manufacturing.

About two dozen Amgen employees spent three days with the Institute, learning the intricacies of working in a certified Good Manufacturing Practice lab. The URI College of Pharmacy hosts the Institute’s world-class, 7,000 square-foot clean lab in the lower level of Avedisian Hall. It is supported by a 1,500 square-foot Analytical and Stability Testing Laboratory on Avedisian Hall’s third floor.

PDI Manager of Operations Cahil McGovern and Coordinator of Training Beth Zielinski-Habershaw led the Amgen employees through an Introduction to Biopharmaceutical Manufacturing, specifically:

Beth Zielinski-Habershaw demonstrates the use of a biological safety cabinet in the cGMP facility
URI Pharmaceutical Development Institute Beth Zielinski-Habershaw demonstrates the use of a biological safety cabinet in the cGMP facility in the lower level of Avedisian Hall. Photo by Patrick Luce
  • Aseptic processing and upstream processes
  • Purification and downstream processes
  • Cleaning and EM monitoring

“Amgen and URI PDI have partnered together to develop an Introduction to Biotechnology training course. This informative three-day training provides functional knowledge and information,” said Sharon Mcguire, senior manager at Amgen. “The information is relatable, digestible and provides a combination of lecture and hands-on laboratory activities associated with cell culture, purification and environmental monitoring that puts learning into practice. Individuals currently working in the industry wanting to learn more about biotechnology processes or those new to the industry can benefit from this training course.”

Malcolm Pluskcal leads Amgen employees through a training session
Industry expert Malcolm Pluskcal leads Amgen employees through a training session in the Analytical and Stability Testing Laboratory, part of the URI Pharmceutical Development Institute. Photo by Patrick Luce

Education and workforce training is just one mission of URI’s Pharmaceutical Development Institute. The Institute also facilitates the development of new pharmaceutics and nutraceutics by researchers at URI and their academic and industry partners, and engages private partners to enhance the economic development of the region’s pharmaceutical and biotechnology industries. Specific services include:

  • Custom development and contract manufacturing: Help academic, government and industry partners rapidly and cost-effectively develop solid dose pharmaceuticals and nutraceuticals for human and veterinary uses. Produce pharmaceutical supplies for animal/toxicology studies and human clinical trials.
  • GMP analytical testing: Provide pharmaceutical testing services, including turn-key stability studies, evaluation of Work in Process at the GMP facility, method development for pharmaceutical product testing, method validation services, and method transfers for scale-ups and automation of existing validated methods.
  • Education and Certification Training: Provide specialized GMP training courses for industry partners, undergraduate and graduate students, adult learners, as well as manufacturing and quality control personnel. Help expand and enhance the region’s pharmaceutical development workforce through industry-specific training programs in collaboration with partnering pharmaceutical and biotechnology firms.

Learn more about how the Institute is committed to helping revolutionize pharmaceutical development and serving as an economic engine in the life sciences industry at uri.edu/pdi.