Nephron gets nod from FDA see more
West-Columbia headquartered-Nephron Pharmaceutical Corp.’s fight against the COVID-19 pandemic has received an additional weapon.
The Food and Drug Administration approved the company’s request to add a production line used in the manufacturing of bronchodilator albuterol today, Nephron CEO Lou Kennedy told the Columbia Regional Business Report.
“This news came in 20 minutes ago,” Kennedy said Monday morning. “People are cheering. It’s like The Price is Right or something.”
Kennedy said she expects to hear whether a second production line has been approved later this week.
Last month, Kennedy petitioned the FDA to add up to six production lines moved to Columbia from the company’s previous Florida headquarters in 2019. Kennedy said the additional lines could help the sterile respiratory medication manufacturer keep up with unprecedented demand.
Kennedy said March saw a 141% increase in the doses of inhalation solutions Nephron typically produces a month.
“We went from a regular month of about 80 million shipped to 193 million shipped in March. That’s just for the respiratory side,” she said. “For our sterile injectable medications that we make for all the hospitals in America that have drug shortage needs, that was up by like 22%. We’re seeing the same exact trend in April.”
Kennedy praised the FDA for its quick response, saying the federal agency granted Nephron a CBE-30, “which means Change Being Effected. That’s giving you a goal date of 30 days or less to review your material and be able to say yes or no,” she said.
“That’s really something. You’ve just got to know and feel good as a patient or a potential patient in America that the FDA has been working with me on the phone almost every day, or by email, trying to get this through expeditiously so that we can crank up a few more lines.
“As much as we can make, we’re selling. I don’t want to get behind. So if we can get these other lines approved pretty quickly, then we’ll be able to pump out — if I get four lines, at least another 50 million a month.”
Also helping meet demand, Kennedy said, are the efforts of the S.C. Ports Authority.
Last Thursday, four gigantic containers of automated packaging equipment arrived at Nephron headquarters from Switzerland. Today, the company is expecting air delivery of critical supplies from Italy, one of the countries hardest-hit by the COVID-19 pandemic.
“You know how difficult that was to pull off?” Kennedy said.
Kennedy developed a working relationship with the port as she moved hundreds of millions of dollars in equipment from Florida to West Columbia when Nephron relocated to South Carolina in 2014. During her time as chair of the S.C. Chamber of Commerce from 2018-19, Kennedy came to know S.C. Ports CEO Jim Newsome and COO Barbara Melvin well.
Expecting last week’s shipment of automated equipment to help Nephron workers quickly label, package and ship products, Kennedy called Melvin.
“I reached out to see what the situation was going to be like in getting these pieces of equipment,” she said. “That equipment, which was four giant containers, arrived to the dot at 9 a.m. (Thursday) morning all because of two great South Carolina partners — UPS and its hub that’s located one exit from me, and the Ports Authority.
“All of these drugs that are packaged will go to benefit speedier to-market products for patients with COVID-19. … This is front-line equipment that we need to get our products to market quicker.”
Nephron is also gearing up to begin releasing 100-mL saline bags for administration of sodium chlorine. The minibags, made scarce after the 2017 hurricane season hit manufacturer Baxter Healthcare hard, are once again in short supply, Kennedy said.
“We are very happy to say that we’ve been producing 100-mL saline for the last two weeks in anticipation for this going on shortage,” said Kennedy, who said the bags would be released this past Friday.
While Nephron has ramped up production in response to previous respiratory illnesses such as SARS and H1N1, Kennedy said the COVID-19 crisis is unlike anything she’s ever seen. Nephron began making its own hand sanitizer last month, distributing 50 liters to the William Jennings Bryan Dorn Veteran Affairs Center.
“I had absolutely no idea we’d reach these levels. I couldn’t even imagine, can’t even imagine, still am trying to process,” Kennedy said. “One particular day, two or three weeks ago, one hospital system in New York ordered 3,000 nebulizers from us. A typical thing might be 50, no more than 100. They ordered 3,000.”
S.C. Ports and other transportation partners have helped Nephron fill the exploding demand, Kennedy said, while Nephron workers are proud to be playing a role in combating the virus.
“I couldn’t even begin to compare ourselves with what they’re doing at hospitals, but there is a true sense of patriotism,” she said. “People are coming to work optimistic in the fact that they’re helping, in their own small way, American patients.”
Monday Moment for 4-6-20 see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 2 minutes or less. This week, enjoy an uplifting reminder from Nephron's Lou Kennedy that we're all in this together, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.
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.”
Nephron partnership helps patients receive anesthetics faster see more
A new partnership between Nephron Pharmaceuticals Corp. and National Medical Products Inc. will help provide more patients with a quick and simple delivery of anesthetic medications, according to a news release from Nephron.
National Medical Products is the developer of the single-use, subcutaneous J-Tip Needle-Free Injector. Hospitals which use the injector will now be able to use Nephron-developed technology in a Luer lock syringe, buffered and pre-filled with lidocaine, to fill it.
“This new partnership is a huge win for patients, and we are extraordinarily excited to announce it,” Lou Kennedy, CEO of West Columbia-headquartered Nephron, said in the release. “Working together with the developers of J-Tip, we are making sure that the delivery of anesthetic medications is safe, easy-to-use and virtually pain-free, because patients deserve nothing less.”
California-based National Medical Products, established in 2001, refined a jet-injection technology previously used by the military for vaccine delivery to create a self-contained injector that uses compressed carbon dioxide to provide an anesthetic effect in one to two minutes, according to the release. The injector is most commonly used before procedures such as IV insertions and blood draws.
Nephron said the companies hope the partnership will help reach more patients.
SCBIO's expanded Board of Directors includes life sciences leaders from across South Carolina see more
Organization’s Boards spans state, industry segments to provide unique blend of expertise for advancing South Carolina’s life sciences industry
GREENVILLE, SC – February 8, 2019 – Less than two years after initiating a comprehensive relaunch of the state’s official life sciences organization, SCBIO has expanded its Board of Directors for its 501c6 operational entity and added a second 10-member Board for its 501c3 research and educational arm for 2019. It does so having authored the state’s first-ever life sciences strategic growth plan, conducted an economic impact study validating the contributions of the $11.4 billion industry, tripled revenues and quadrupled membership – all since Spring 2017.
And according to SCBIO President and CEO Sam Konduros, the best and most exciting days for the industry and organization are still ahead of it.
“In a state perhaps best known for building BMWs and Boeing Dreamliners, there is a very strong life sciences story brewing as well, creating opportunities to diversify and accelerate growth of our state’s knowledge economy,” said Konduros recently. He further cited rapid growth of such national and global brands including Nephron Pharmaceuticals, Arthrex, ZEUS, Abbott, Thorne and AVX as just a few examples of the state’s rapidly rising life sciences industry, which currently spans more than 400 companies in 44 counties and employs over 15,000 well-paid associates.
Leading the policy- and strategy-making efforts of the 501c6 entity of the non-profit organization, the Board of Directors meets regularly to receive updates on SCBIO business objectives, domestic and global initiatives, and to help hone strategies and offer insight. Nephron Pharmaceuticals Corporation CEO Lou Kennedy will serve as SCBIO’s 2019 Board Chair; Stephanie Yarbrough, Womble Bond Dickinson, LLP as Vice Chair; Michael Rusnak, Medical University of South Carolina Research Foundation as Treasurer; and Josh Ridley of ZEUS as Secretary.
Jeff Stover of Haynsworth Sinkler Boyd, PA will serve as Legal Officer; Heather Simmons Jones of the Greenwood Partnership Alliance as Annual Conference Officer; Bryan Davis of Prisma/Greenville Health System’s Office of Innovations as Healthcare/Innovation Officer; Adam Hoots of DPR Construction as Talent/Workforce Officer; and Sam Konduros, President and CEO of SCBIO.
Recently added members of the SCBIO Board of Directors are:
Mike Briggs – President & CEO, Central SC Alliance
Caroline Brown – Director of External Affairs, Medical University of South Carolina
Thornton Kirby – President & CEO, South Carolina Hospital Association
Adam Klonecke – Senior Site Director, Abbott
Angie Leidinger – VP of External Affairs, Clemson University
Tom McKenna – Chief Operating Officer, Thorne
Robert Ryan – CEO & Founder, Innova Therapeutics
Dave Shalaby – President, Poly-Med, Inc.
Will Williams – President & CEO, Economic Development Partnership (Aiken)
Cynthia Young – Dean, Clemson University College of Science
Returning members of the SCBIO Board for 2019 are:
Mandy Brawley – South Carolina Department of Commerce
Matthew Couvillion – Wyche Law Firm
John J. Darby – Johnson & Johnson Services
Tressa Gardner – SE Institute of Manufacturing & Technology
Mike Graney – Charleston Regional Development Alliance
Chad Hardaway – University of South Carolina Office of Economic Engagement
Will Harms – Blue Cross Blue Shield of SC
Erica Jackson – K&L Gates
Marc Metcalf – Upstate SC Alliance
Kathy Phlegar – Phlegar & Associates
Christine Dixon Thiesing – SCRA
Courtney Warren – Marsh & McLennan Agency
Comprising the smaller Board of SCBIO’s 501c3 research and educational arm are Kathryn Becker of Translational Science Solutions; Michael Bolick of Treis Blockchain; Matthew Couvillion of Wyche Law Firm; Shontavia Johnson of Clemson University; Steve Johnson of SCRA; Chris Przirembel, retired Clemson University executive; Shawn Regan of Rhythmlink; Craig Walker of Hitachi Healthcare Americas; Erica Jackson of K&L Gates; and SCBIO CEO Sam Konduros.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms directly involved and 15,000 professionals employed in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in advanced medicines, medical devices, diagnostics, IT, and healthcare outcome industries.
SCBIO is the official state affiliate of BIO -- the world's largest trade association representing biotechnology organizations. SCBIO members include academic institutions, biotech companies, med-tech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups whose members are leading the research and development of innovative healthcare, agricultural, industrial and environmental biotech and med-tech products that will make a difference across the Palmetto State, and around the world.