sterile manufacturing

  • Sam Patrick posted an article
    Nephron seeks to stem coronavirus concerns with expanded offerings see more

    In response to the novel coronavirus pandemic, West Columbia-based Nephron Pharmaceuticals Corp. has asked the Food and Drug Administration for permission to add up to six filling lines to ramp up its production of sterile respiratory medication.

    Nephron CEO Lou Kennedy said she spoke with the FDA on Tuesday morning and is “waiting to hear back.” Kennedy also said Nephron will begin making its own hand sanitizer as early as this week.

    Nephron, which CEO Lou Kennedy said is one of two companies in the U.S. that produce 98% of the nebulizer solutions used in hospitals or sold in retail outlets, relocated to South Carolina from Florida in 2014.

    “We didn’t move all the equipment right away,” moving an additional six filling lines to South Carolina in 2019, Kennedy said. She said she had been in discussion with the FDA for permission to bring those machines online. A meeting had been scheduled for March 22 before she made another request Tuesday.

    West Columbia-based Nephron has asked for FDA approval to add up to six filling lines for its respiratory medication manufacturing. CEO Lou Kennedy also announced the company will begin making hand sanitizer this week. (Photo/File)

    The eight filling lines currently being used in production of the inhalation solutions Nephron makes typically produce 80 to 85 million doses a month “on a regular basis” and are capable of making up to 110 million monthly doses, Kennedy said.

     

    “As of yesterday, we had orders on the books for 87 million, so already a month’s worth,” Kennedy said. “For the last two weeks, those orders have been running about 48% higher than we would normally see. … We do have backstock that we’ve built up in inventory, (but) that won’t last forever.”

    To maximize Nephron’s 24-hour, seven-day-a-week production schedule, Kennedy said the company has begun providing in-house child care. Children are provided food, and already stringent cleaning efforts have been “tripled,” Kennedy said. She said the same methods used to maintain sterile facility conditions, including the use of a fogging machine and wiping down surfaces with isopropyl alcohol and hydrogen peroxide, are being deployed in the day care.

    “We’re really good at cleaning here, because we only make sterile drugs,” Kennedy said. “I’m very confident about making a clean environment for these children.”

    During a conference call Tuesday, Kennedy also said Nephron has received FDA approval to begin making its own hand sanitizer and ordered supplies to do so on Monday.

    “We will take care of the Nephron family first, and after we do that, we will look at should we go through churches, the Salvation Army, how can we help the community, and/or commercial production,” she said. “I’ve had at least six requests from various sales reps across the country. Hospitals are asking can we make that hand sanitizer for them.”

    The plan is to produce 50-liter batches of a strong, FDA recipe without fragrances or other diluting agents, Kennedy said. She said she will gift what is left over from the first batch, after Nephron employees and their families have been served, to local charities.  

    Kennedy said as early as December, Nephron began taking stock of things such as the resin used to make vials of its liquid medication as well as its supply of active pharmaceutical ingredients. “We are fortunate that we have more than a year’s supply of that (API) on hand,” she said.

    Nephron makes bronchodilators including albuterol used to treat respiratory illnesses such as bronchial asthma, pneumonia, emphysema and croup. It also manufactures Pocket Nebs, which are portable, battery-charged nebulizers.

    Novel coronavirus can cause cough, shortness of breath and breathing difficulties. Severe infections can lead to complications including pneumonia, according to the World Health Organization.

    Increased product demand during cold, cough and allergy season, as well as past experience with respiratory illnesses including SARS and H1N1, have made the company ever-vigilant, Kennedy said.

    “We make sure to be very rock-solid in our preparation to accommodate the needs of America,” she said.

    Kennedy said hiring and training has already begun in anticipation of FDA approval of the additional filling lines.

    “We have the people to be able to ramp that up right now,” she said. “ … If we don’t get our hands wrapped around this quickly, meaning we squelch the spread, get control of the spread, it’s going to be a long, hard road. But it’s easily solved if the FDA allows me to ramp up the five or six other lines that I brought here from Florida.”

  • Sam Patrick posted an article
    Nephron, Clemson partner to meet hospital needs see more

    Nephron Pharmaceuticals Corporation is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing in the pharmaceutical production process and keep up with growing hospital demands.

    “We are excited about our new partnership with Clemson and we cannot wait to get started,” said Nephron CEO Lou Kennedy. “Working together with Clemson’s world-class researchers and engineers we can ensure that the pharmaceutical manufacturing process remains safe and we can deliver life-saving drugs to patients and hospitals across the country.”

    The university’s newest strategic partner is turning to Clemson to harness the power of technology for more efficient processes. To do so, Nephron is enlisting the expertise of the College of Engineering, Computing and Applied Sciences professor and researcher Yue “Sophie” Wang and mechanical engineering doctoral student Brandon Delspina and mechanical engineering master’s student Yu “Gloria” Zhang.

    Their robotics research for syringe automation will support 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.

    Based in West Columbia, Nephron is a certified woman-owned business and one of the fastest-growing companies in South Carolina. This is Nephron’s first partnership with the university and was developed through External Affairs’ Office of Corporate Partnerships and Strategic Initiatives at Clemson University.

    “When the External Affairs’ Office of Corporate Partnerships and Strategic Initiatives approached us about this project we were excited to get involved,” said Wang, associate professor of mechanical engineering. “Our work in robotics can have a tremendous impact on individuals across the country and we are looking forward to working on this because of its benefits for the many patients Nephron serves.”

    “Industry needs are changing at a rapid rate and Clemson is equipped to support companies like Nephron. Together, we have created a mutually beneficial project to enhance their capabilities while providing the university’s students with unique, hands-on research experience,” said Angie Leidinger, vice president for External Affairs. “This partnership is a testament to the work happening at Clemson and we’re looking forward to this collaboration, which will advance their business and benefit South Carolinians.”