Nephron went looking for a way to automate syringe-filling for small batch manufacturing, found more see more
t’s no secret that working long hours in a cleanroom environment can be grueling. The bunny suits can get sweltering and the hours doing monotonous tasks can drag. On top of that, staffing cleanroom techs for an around-the-clock operation can be a major challenge for pharma companies.
With the hope of overcoming these issues, South Carolina-based Nephron Pharmaceuticals recently went looking for a way to automate syringe-filling for small batch manufacturing and turned to the brainpower nearby.
Within the University of South Carolina, the Office of Innovation, Partnerships, and Economic Engagement (OIPEE) provides a way for companies to engage with students and faculty to solve vexing industry problems.
“The university can bring a client in, and we’ll create a solution for that client with advanced manufacturing,” Bill Kirkland, executive director of OIPEE, explains.
For Nephron, that solution was robotics. After striking up a partnership, students and researchers from UofSC eventually innovated a new automated syringe-filling system that utilizes flexible, high-speed robots provided by Yaskawa Motoman and processing power developed by Siemens. According to Kirkland, the system’s robotic arm that works under a single hood is part of what makes it unique. It was also designed specifically for small-batch operations, and importantly for Nephron, the new technology will help eliminate manufacturing downtime.
“We have a workforce issue in that we have lots of trained sterile pharma techs, but expecting them to show up every shift 24/7 is challenging,” Lou Kennedy, CEO of Nephron, says. “So, for example, if someone calls in sick, this allows us to do many steps using robotics, and it keeps us from having to shut down.”
Although there are other robotic syringe-filling solutions on the market, Kennedy says she has never seen a system as small and nimble as the one built by UofSC.
“It operates underneath a flow hood in a cleanroom and that’s important because we are working with injectables,” Kennedy says. “And it’s compact and can move from one cleanroom to another.”
After the technology was developed, the system was installed in a Nephron facility earlier this year, where Kennedy says the company is perfecting the tech and it is being commercially validated. Once they find the manufacturing “sweet spot” and it wins regulatory approval, the companies plan to license and commercialize the technology. Ultimately, the plan is to target biopharma facilities and hospitals in need of small-batch manufacturing solutions.
“By virtue of its previous relationships with Yaskawa and Siemens, UofSC faculty and OIPEE pitched this solution to Nephron, who agreed to bear some of the initial cost of setting up the research facility in the McNAIR [Aerospace] Center,” Kirkland said in a statement this spring. “All three companies, as well as the university, will benefit greatly from the introduction of this system into the commercial space.”
In addition to being a boon for the Nephron, the collaboration also showcased how industry partnerships can be a stepping stone for engineering and manufacturing students — including those who were not considering a career in pharma before. According to Kirkland, one of the students involved in the collaboration went on to score a job at Siemens, and another did the same at Nephron.
“Partnerships like this one are a win for patients, employees and students, not to mention for companies like ours, that continue to grow and expand our capacity to help others,” Kennedy said in a statement this spring.
Life sciences booming in Spartanburg, Upstate see more
Spartanburg County – and the entire Upstate – are welcoming a growing interest and investments from life sciences companies. The Upstate has a long-established history and infrastructure that have supported life sciences companies with raw materials, production and packaging operations, and distribution.
Now, new research and innovation businesses are further supporting industry growth and fueling an ecosystem ripe for start-ups.
More than 670 life sciences firms of all sizes call the Upstate home, with 13 companies announcing new locations in the area in the last few years.
The newest of those companies in Spartanburg is Epica International, the leader in advanced, ultra-high-resolution mobile medical imaging and robotic applications for human and animal health, and industrial enterprises.
The company announced its headquarters and operations in Spartanburg, covering its subsidiary companies Epica Human Health, Epica Animal Health and Roboticom. Epica established corporate, imaging and robotic system demos at its facility, currently located inside the Spark Center SC on the Tyger River Campus of Spartanburg Community College.
“Epica’s investment in Spartanburg goes hand-in-hand with a diversified economic development strategy we’ve put in place countywide, targeting specifically investments from bioscience and life sciences industries,” said OneSpartanburg, Inc. Chief Economic Development Officer Katherine O’Neill. “These types of advanced, heavy-technology industries coming to our county gives us a considerable strategic advantage for future development and job growth.”
Another life sciences company – Pall Corporation – announced its intent to invest in Spartanburg County earlier in 2021. Pall announced its Spartanburg County operations would create 425 new jobs and $30.2 million in investment.
Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies. The company’s Spartanburg facility supports the rapid development of vaccines and therapeutics, including COVID-19 vaccines.
"Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county,” said Pall Life Sciences President Joseph Repp at the time of the company’s announcement.
Statewide, South Carolina has a significant presence in the medical device sector. And the manufacturing supply chain is robust when it comes to life sciences, mirroring the strength of the area’s overall manufacturing prowess.
From 2015-2019, medical devices and equipment companies added 35% more jobs and accounted for 11.5% of the new companies coming to the Upstate. And on top of that, more than 700 clinical trials are being undertaken across the Upstate at any given time in the fields of oncology, companion diagnostics, genetics and more.
The Upstate in particular has a network of acclaimed hospitals, technical training schools and more than 26 colleges and universities actively working with industry leaders and educators on all levels to ensure access a highly-skilled workforce for decades to come.
“Spartanburg’s historic advantages when it comes to infrastructure, distribution capabilities and even the county’s location, make it a favorable home for continued investments from biosciences and life science industries,” said O’Neill. “That positions us well for the future as these industries continue to bring higher-wage, knowledge-based jobs to Spartanburg.”
South Carolina-based firm names new head of pharma and medtech see more
DUNCAN, SC - Stäubli announced today that Olivier Cremoux has been appointed Deputy Head of Pharma and Medical Device for Stäubli Robotics North America.
Cremoux joined Stäubli Group in 2015 before transferring to Stäubli Corporation as the North American Business Development Manager for Robotics in 2018. Most recently, he became Key Account Manager – Pharma and will maintain this role throughout the transition period. Cremoux will use his experience to help build the Medical Robotics team while focusing on the Pharma and Medical Device specific markets.
Cremoux graduated from the National Institute of Science Applied of Lyon (France) with a bachelor degree in Electrical Engineering.
Commenting on the announcement, North American Robotics Division Manager, Sebastien Schmitt stated, “We are pleased to announce Mr. Cremoux as Stäubli Robotics North American Deputy Head of Pharma and Medical Device. We believe Mr. Cremoux is the right leader for Pharma and Medical Device as we continue to expand our growing team. This is an important step in setting up an organization fully dedicated to the pharmaceutical industry to build on our existing expertise in a number of high‑tech markets.”
Olivier Cremoux: “I am honored by such an opportunity within Stäubli Robotics. The Pharma and Medical Device is a strategic and growing market in which Stäubli has provided, for over 20 years, significant technological innovations. High throughput screening, aseptic fill/finish, orthopedic surgery, bio-printing and cell culturing are examples of processes where Stäubli Robotics started as a pioneer and became a reference. With COVID-19 pandemic, robotics became even more essential to our customers, from drug production to Covid test manufacturing. In North America, we will continue the development of our organization to ensure all current and future needs of our customers.”
About Stäubli Robotics
Stäubli Robotics is a leading global player in robotics, consistently delivering engineering as effective and reliable as our service and support. A complete solutions provider for digitally networked production, Stäubli offers a broad range of 4- and 6-axis robots including robotic arms designed specifically for sensitive environments, autonomous mobile robots, driver-less transport systems (AGVs) and cobots for human-robot collaboration. www.Stäubli.com/robotics
About Stäubli North America
Stäubli North America has more than 200 employees supporting Connectors, Robotics and Textiles customers. The company’s North American headquarters is in Duncan, South Carolina. Stäubli provides customer support through its locations in Duncan, Queretaro, Mexico, and the newest Stäubli North American facility, which opened in 2018 in Novi, Michigan. In addition to 24/7 customer support, each of these facilities offers training and has dedicated on-site technical experts who can be deployed whenever needed. Stäubli’s North American sales force is located strategically on the West and East coasts, and also serves Canada and Puerto Rico.
Worldwide, Stäubli is a leading manufacturer of quick release couplings, robotics systems and textile machinery. With a workforce of more than 5,500 employees, Stäubli is present in 29 countries supported by a comprehensive distribution network in 50 countries worldwide.
Nephron'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.