Alcami and the University of North Carolina Wilmington (UNCW) have partnered on an academic program that connects education and work experiences for students pursuing scientific careers, especially in pharmaceutical sciences. This edition of the Beyond the Bench series will highlight the laboratory-based course taught at UNCW’s state-of-the-art marine biotechnology center (MARBIONC), “Current Good Pharmaceutical Quality Control Laboratory Practice,” focused on the application of Current Good Manufacturing Practices (cGMPs) in a drug development and testing laboratory.

In 2016, leaders from Alcami and UNCW met to discuss potential opportunities to work together on biopharmaceutical projects. Many of Alcami’s Wilmington employees are UNCW graduates, and Alcami has a long history working with the university on employee education programs and pharmaceutical projects. Steve Fontana, JD, from UNCW’s Office of Intellectual Property and Commercialization; UNCW Chancellor Dr. Jose V. Sartarelli, and Alcami President and Chief Executive Officer (CEO) Dr. Stephan Kutzer initiated conversations that resulted in the development of the present partnership.
“Alcami professionals have the expertise to prepare students for careers in the biopharmaceutical industry, and the executive leadership of Alcami and UNCW developed a plan to offer courses to students. Both sides are benefitting from this partnership,” said Jonna Clark, Alcami Scientific Advisor and liaison for university relations. “UNCW graduates employed at Alcami have a broader understanding of the pharmaceutical industry that will accelerate their careers. These employees will start their careers understanding the importance of regulatory compliance, safety, quality, honesty, and integrity in the industry.”

Led by Clark, several guest Alcami scientists lectured in the classroom and taught in the labs to provide a robust educational experience. “The UNCW students received hands-on experience within a GMP environment that potential employers will look for in their new hires,” commented Dr. Will Boomershine, a subject matter expert at Alcami for structural chemistry and biotechnology.

Throughout the course, Alcami scientists have shared their experiences with the next generation of scientists who will be the future of Alcami. “I would highly recommend this course to any student interested in a science-related career, not just those interested in pharmaceuticals. Experience in a GMP environment provides a preview of what is expected of a scientist in the pharmaceutical field from both a scientific and regulatory perspective. Even for students who are not interested in pharmaceuticals, the class provides insight into the highly-regulated environment of pharmaceuticals, providing a glimpse into this industry. Having an understanding of GMP regulations can also help academic labs in the development of new drugs,” stated Boomershine.

Kyle Chenevert was a biology and chemistry senior when he took this class and “felt this course prepared me for my career in science by simultaneously giving me experience with GMP lab testing and documentation and helping me build relationships with experienced industry mentors.” Following the course and his graduation from UNCW, Chenevert joined Alcami as an assistant scientist on the structural chemistry and biotechnology team. “In my case, the transition from student to employee was a very comfortable one. Having an opportunity to be exposed to a GMP lab environment prior to my first day of work allowed me to put all of the information I was being given into context. On top of that, the benefit of walking into that first day with a few familiar faces made joining the team a breeze. I’m still learning more with every passing day, but I can say with no hesitation that taking the GMP course at UNCW made a hugely positive impact on my onboarding experience,” Chenevert explained.

Notable favorite topics for the students in the course included dissolutions, bioassay, high-performance liquid chromatography (HPLC), biopharmaceutical bicinchoninic acid (BCA) assay lab, and meeting and networking with a multitude of scientific professionals.
 
“This class uses real scenarios that we will encounter in the workplace, such as GMP regulations and technique and lab tasks. Most classes merely supply you with a lecture and scenario-based lab, whereas this class uses all of the same materials and instruments that you would find in real life,” said Ashley Bissette, who took the class as a clinical research and biology junior. “I really enjoyed the connections I made throughout this course. It was no secret that this course was a challenge for me from the beginning as I had only taken Chem 101, but Jonna Clark and the other Alcami scientists were always willing to answer questions, help me understand the concepts…[and] apply this knowledge in the lab and see the process behind drug manufacturing,” she said. Bissette went on to intern at Alcami as part of the scientific support services team over the summer.

“As a guest lecturer in the class, the students also taught me many things,” Boomershine said. “First, they shared their interests scientifically and what they are learning in their other classes. They also shared what they are looking for in an employer. As future leaders in the scientific community, it is important to understand what the current students are looking for in an employer so Alcami can attract and retain talented young scientists.”

“I have recommended this class to many students interested in the same path I took, doing lab research work, because it really made a huge difference,” added Bissette. “I feel I have an advantage over my classmates because I have seen cGMP applications first hand. I hope to take the knowledge into my future clinical research career!”

Alcami is scheduled to meet with UNCW faculty prior to the fall 2019 semester, and hopes to incorporate these courses into the curriculum at UNCW as electives. Additionally, the lecture series is currently being converted to an online course that may be shared at universities near other Alcami sites or ones affiliated with the National Institute for Innovation Manufacturing Biopharmaceuticals (NIIMBL) organization. NIIMBL is funded through a cooperative agreement with The National Institute of Standards and Technology (NIST), a program dedicated to promoting innovation and industrial competitiveness. The ultimate goal is to develop a sustainable program, advance regional expertise, and produce new talent for the pharmaceutical industry.

Current Good Manufacturing Practices courses will be offered again through UNCW to undergraduates for the fall 2019 semester. If you are interested in learning more about this program, or know a student who would like more information, please contact Jonna Clark.

Catherine Hanley is Alcami’s Vice President and Head of Marketing. She is the leader behind the company’s brand development and awareness strategies toward expanding Alcami’s global presence, thought leadership, customer experience, first to market initiatives and the implementation of inbound marketing & sales strategies. She additionally directs media relations, advertising, and design, and oversees events, sponsorships, community outreach and charitable contributions. For more information visit alcaminow.com.