sam patrick posted an articleNephron's Lou Kennedy making a big impact on industry see more
Courtesy of SC Manufacturing
Drug shortages have plagued the health care system for decades. Even prior to COVID-19, hospitals incurred more than $400 million in labor costs and alternative treatment options due to national generic drug shortages, especially for those administered via injection.
More important, research shows shortages lead to adverse patient outcomes – things like delaying critical procedures, rationing doses based on supply levels and prescribing suboptimal treatment plans with substitute drugs.
Manufacturing tops the list as the most common cause of shortages, pushing those in the pharmaceutical supply chain to look for new ways to increase productivity – and thanks to a partnership between Clemson University and Nephron Pharmaceuticals Corporation, a solution may be on the horizon.
Led by Dr. Yue “Sophie” Wang, the ambitious project combines robotics and medicine to ensure sterility, quality, safety and efficiency in pharmaceutical manufacturing. The team worked in partnership with South Carolina-based Nephron Pharmaceuticals Corporation to develop a flexible, easy to use, open-source benchtop robot that can fill, cap and seal sterile syringes.
“Pharmaceutical collaborative robots is a new and quickly growing research area,” said Wang, who serves as the Warren H. Owen Duke Energy Associate Professor of Engineering at Clemson University. “By combining our expertise with unique applications in pharmaceutical manufacturing, we hope to benefit both patients and the industry through increased efficiency in syringe manufacturing.”
The project supports the Nephron 503B Outsourcing Facility, a cGMP manufacturer providing sterile, pre-filled medications to address persistent drug shortages in hospitals and medical facilities across America. Pre-filled syringes help control costs by minimizing drug overfill and minimizing microbial contamination. Without robotics, filling these syringes is a delicate, highly regulated process completed by specialized technicians under laminar airflow hoods in ISO classified clean rooms to keep their work environments sterile.
It can take up to five employees a day per hood to meet the incredible demand for pre-filled syringes at Nephron. Unlike humans, robots don’t get tired, offering advantages in quality control, production planning and compliance.
Technicians can then be re-deployed for higher value functions that let them improve their skills, experience and pay, said Nephron CEO Lou Kennedy.
“Anything we can do to improve drug shortages, that’s just good for patients,” she added. “It’s a very big crisis, not just in the U.S. but globally as well.”
The next phase of the project is further development, starting with the completion of a purpose-built clean room on Clemson’s campus. Kennedy hopes to commercialize the benchtop system for use inside healthcare facilities across the country.
“Hospitals often have two or three pharmacists working the phones every day searching for the drugs they need,” said Kennedy. “You don’t go to school for eight years to spend your day on the phone looking for product.”
Partnering for change
Clemson and Nephron are at the forefront of a larger trend shaping pharmaceutical manufacturing today. The integration of automation, AI and robotics are catalyzing the industry, and rising demand paired with major market disruptions such as COVID-19 are only accelerating change. The pharmaceutical robotic systems market is expected to nearly double to $119.46 million from just five years ago, driven by innovations in packaging, inspection and lab work, according to one report.
Part of what has made the project successful is the complementary strengths Nephron and Clemson brought to the table. Wang needed an insider’s perspective on pharmaceutical manufacturing to understand the exact requirements and processes involved in sterile syringe production.
Based in West Columbia, Nephron is a certified woman-owned business and one of the fastest-growing companies in South Carolina. The partnership was developed through External Affairs’ Office of Corporate Partnerships and Strategic Initiatives at Clemson University.
“As a leading pharmaceutical manufacturer, Nephron is the perfect partner for specialized, high-impact research to improve health outcomes for patients,” said Angie Leidinger, Clemson’s vice president for External Affairs. “Thanks to our partners, our breakthrough research continues to build Clemson’s and South Carolina’s reputation for leadership in both advanced manufacturing and life sciences.”
In addition to Clemson’s world-class research talent, Nephron was also drawn to the University’s steady stream of talented graduates that could hit the ground running at their facilities.
“We’re a young company and want to play a role in developing all of this great talent we have around us,” said Kennedy. “I decided it was time to put game day feelings aside and look at where our talent was really coming from.”
Women taking the lead
Like most STEM industries, women continue to be a minority in the pharmaceutical manufacturing workforce, at 42.3 percent of total employment. If the partnership between Clemson and Nephron is any indication, that gap could be shrinking fast.
With Kennedy at the helm, Nephron is a certified woman-owned business and boasts a 53 percent female workforce. Ratios like that are unheard of in our industry, she says. It’s only fitting that project leadership from the Clemson side is female.
Clemson is home to many groundbreaking women in the industry, including Martine LaBerge as chair of the Department of Bioengineering, Saara DeWalt as chair of the Department of Biological Sciences, and Delphine Dean as the Ron and Jane Lindsay Family Innovation Professor, among many others. Dean is also a key researcher and first line of defense in the University’s response to the global pandemic.
“It’s so pleasant to see women thriving in STEM careers,” said Kennedy.
sam patrick posted an articleClemson partnership extends reach to India and beyond see more
Clemson University researchers said a new partnership with one of India’s top engineering universities will lead to new medical devices, sensors and startup companies, while helping educate leaders and entrepreneurs for the global healthcare industry.
Clemson is joining with the Indian Institute of Technology Delhi to create the Center for Innovative Medical Devices and Sensors.
The long-term vision for the center includes exchanges of faculty members, students and post-doctoral researchers, and to eventually establish joint courses. Some of the first projects will focus on solutions for diabetes and other chronic health issues common to both countries.
The first exchanges could begin as soon as next summer.
Researchers plan to focus on technology that is close to going from the lab to the marketplace, a concept that scholars call translational research. The devices that researchers develop could lead to biomedical start-ups — and the lucrative jobs that come with them– in South Carolina and India, they said.
An advantage to cross-border research is that new technology will be designed to meet regulatory requirements in multiple countries, smoothing the transition to markets around the globe, said Delphine Dean, who is the Gregg-Graniteville Associate Professor of Bioengineering at Clemson.
The collaboration is the latest in a growing number of links between South Carolina and India, a connection that could help build both economies, she said.
“If a company wants to have a landing base to do FDA testing, South Carolina is a great area to do it in,” she said. “We have a lot of resources at the state level, and I think it will help drive economic development. When you go visit IIT Delhi, they know Clemson, and they know South Carolina.”
Dean is coordinating the center with Sandeep K. Jha, an assistant professor in the Centre for Biomedical Engineering at IIT Delhi.
Jha said the joint center with Clemson will be a win-win for both institutions and that they will develop several vital technologies by working together.
“The research and continual development in the field of medical sensors and devices is the need of the hour,” he said. “Most of the conventional technology related to healthcare and diagnostics have gradually been shifted towards automation, miniaturization and cost-effectiveness.
“In this regard, a research collaboration with Clemson University to develop cutting-edge medical technology would be beneficial for India, as it imports the majority of its medical devices and technologies. Medical devices and sensors could also help to meet several critical needs of South Carolina.”
For Clemson students, the opportunity to visit labs and do research in India will encourage global-scale thinking.
“If I were an undergrad, I’d think this was a great opportunity,” Dean said. “You go enjoy an experience in India and then you get your engineering degree. Then you’re a hot commodity for a job.”
IIT Delhi students will be visiting Clemson primarily for research, graduate studies and specialized bioengineering programs. Those programs include the Master of Engineering program and Green MD, an initiative focused on medical device recycling and reprocessing.
One of the attractions for IIT Delhi students is that they will have a chance to work with Clemson faculty who have extensive experience in translational research, said Brij Khorana, the chief scientific advisor for the College of Engineering, Computing and Applied Sciences at Clemson.
“By working with these Clemson faculty members, they will have the opportunity to gain entrepreneurial skills and participate in start-up businesses here, and then perhaps some of these students can go back to India and help with the healthcare industry there,” Khorana said. “Over time, this collaboration can just grow and grow.”
Some of the students’ work will be on the main campus, and some will be in Greenville at the Clemson University Biomedical Engineering Innovation Campus. The campus, also called CUBEInC, is at Greenville Health System’s Patewood campus.
Clemson’s close connection with clinicians at GHS and Medical University of South Carolina will be appealing to IIT Delhi students, Dean said. Clinicians play a crucial role in guiding research, ensuring that it reflects what happens in real-world hospitals and clinics.
Martine LaBerge, chair of the Department of Bioengineering at Clemson, said the new center will create a unique environment for healthcare education and research.
“The Center for Innovative Medical Devices and Sensors sets the stage for integrative learning and inventing experiences,” LaBerge said. “Students will learn the leadership, entrepreneurial and technical skills they will need to support and enhance a knowledge-based economy.”
The collaboration between Clemson and IIT Delhi brings together two institutions noted for their work in engineering and healthcare.
IIT Delhi was the third highest ranked Indian university in the latest QS World University Rankings. The institute also tied for No. 1 in engineering among Indian universities in the annual “Performance Ranking of Scientific Papers for World Universities” by National Taiwan University.
Clemson is renowned as the birthplace of the field of biomaterials and was among the first universities in the United States to start a bioengineering program, awarding its first Ph.D. in 1963. The university played a central role in creating the Society for Biomaterials.
Anand Gramopadhye, dean of Clemson’s College of Engineering, Computing and Applied Sciences, said the center will enable transformative research and deepen the talent pool for the healthcare industry.
“By coming together, Clemson and IIT Delhi will be able to accomplish much more than we could apart,” he said. “We are creating the conditions for a wider pipeline between academia and industry, as well as a healthier global society.”