Skip to Main Content

503B

  • sam patrick posted an article
    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.

  • sam patrick posted an article
    Life sciences executive named to national NAMB Board see more

    Nephron Pharmaceuticals Corporation today announced CEO Lou Kennedy as a new member of the National Association of Manufacturers Board of Directors.

    Kennedy, who was elected on Monday, joins the NAM Board to bolster the association’s leadership in policy advocacy, workforce solutions, legal action, operational excellence and news and insights. She will help the industry advance an agenda that promotes growth and prosperity for all Americans.

    “I could not be more excited and honored to join the board,” said Kennedy. “Our team has been fortunate to work with NAM over the last few years on critical issues, from COVID-19 to workforce development, and we are always impressed by the results NAM delivers for its members, as well as for employers and employees across the nation.”

    NAM and its members are at the forefront of every important policy debate for manufacturers and have led the nation’s response to COVID-19. 

    Board members play a key role in the NAM’s “Creators Wanted” campaign, a member-driven initiative to inspire and drive more Americans to pursue careers in modern manufacturing.

    “Lou Kennedy is a recognized leader in our industry, and the NAM will be stronger thanks to her service on our Board of Directors,” said NAM President and CEO Jay Timmons. “Manufacturers are the driving force behind our economic recovery and our fight to defeat COVID-19. We are working with lawmakers to ensure they deliver the relief America needs and the long-term policy work on issues like infrastructure investment, immigration reform, trade expansion and workforce development. We will also defend the progress we’ve made on tax reform and regulatory certainty to ensure we can keep our promises to invest in our people and communities and build the strongest economy possible. The NAM’s mission is to ensure we always keep moving forward, and Lou will bring invaluable insights as we advocate for the men and women of our industry and advance the values that have made America exceptional and our industry strong — free enterprise, competitiveness, individual liberty and equal opportunity.”

    A West Columbia, S.C.-based company, Nephron is a nationwide leader in the development and production of safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. The company recently opened a CLIA-certified diagnostics lab, conducts COVID-19 tests and administers vaccines. Nephron announced a new $215 million investment and expansion in July, signaling a new era of unprecedented growth, including the establishment of a vaccine production facility.

    The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 63% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

  • sam patrick posted an article
    Company Excited to Expand Generic Portfolio see more

    WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation is celebrating another milestone.

    The company today announced Food and Drug Administration (FDA) approval of the Nephron Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials. The vials are made of polypropylene plastic with a “luer lock” interface for needle-free dosing and are manufactured using Blow-Fill-Seal (BFS) technology.

    Ketorolac Tromethamine becomes one of the first ANDA-approved non-respiratory generic medications produced by Nephron, signaling a new phase of company growth. Nephron secured FDA approval for Sodium Chloride IV Bags earlier this year.

    “We are extraordinarily excited to expand our generic medication portfolio to include non-respiratory products,” said Nephron CEO Lou Kennedy. “This is the latest sign that Nephron is growing, and it represents a real reason for our entire team to celebrate.”

    Nephron-manufactured Ketorolac Tromethamine is an injectable medication for the short-term treatment (up to 5 days) of moderately severe acute pain. Commonly used after surgeries and other medical procedures, Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID).

    A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products.

    The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. The company recently opened a CLIA-certified diagnostics lab and conducts COVID-19 tests for people across South Carolina.

    Prescribing information for Ketorolac Tromethamine Injection Vial UPS, 60 mg/2 mL (30 mg/mL) is available on the product package insert. More product information regarding Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials is available here