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.”
Performance Validation Becomes a 100% Employee Owned Company see more
INDIANAPOLIS, Jan. 3, 2018 /PRNewswire/ -- Performance Validation (PV), a nationwide leader in providing commissioning, qualification, validation, and quality services to the pharmaceutical, biotechnology, and medical device industries, is pleased to announce the company has established an Employee Stock Ownership Plan (ESOP), becoming a 100% employee owned company.
Research has shown that ESOPs, coupled with a strong employee ownership culture (characterized as a strong organizational identity, and involvement oriented management philosophy), outperform comparable companies that are non-employee owned. The President of Performance Validation, and Kelso Fellow from Rutgers University, Richard Van Doel, Ph.D., stated "The ESOP is a great way for all of Performance Validation's employees to share in the wealth that they have helped to create. Our culture is characterized by similar traits of empowerment, team building, and employee involvement. While our culture has facilitated past success, the addition of broad based employee ownership will provide a direct connection between employee actions and company outcomes."
Employee education is a key element to the success of the ESOP, and Performance Validation has been preparing to establish the ESOP for quite some time. These steps have included joining The ESOP Association and the National Center for Employee Ownership, as well as participation at state and national level conferences. Additionally, PV has conducted training on employee ownership with all employees prior to the transition to an employee owned company.
Performance Validation was founded in 1988 by W. Thomas Stevens, a longtime advocate of employee ownership. Our teams have experience providing turnkey solutions to your project needs, or can provide resources to supplement your existing team. We have supported projects ranging from 1-2 week system qualifications to multi-million dollar greenfield manufacturing facilities – and everything in between. Learn more at www.perfval.com.
Ritedose investing $10MM to expand in South Carolina see more
COLUMBIA, S.C. – The Ritedose Corporation, a pharmaceutical products manufacturer, is once again expanding its Richland County operations with a $10 million investment.
Ritedose, which specializes in the production of inhalation products, eye drops, ear drops and oral liquids, has operated at Carolina Research Park for more than 20 years. In 2014, it expanded its operations and now plans to do so again with a new 140,000-square-foot facility at the Enterprise Industrial Campus of Midlands Technical College. Owned by the college, the business park is a 150-acre property off Powell Road in northeast Columbia, S.C.
For more information on The Ritedose Corporation, visit www.ritedose.com(link is external).
“This new facility represents the Ritedose Corporation’s continued commitment to Richland County, and is indicative of the company’s mission of maintaining our position as a global market leader.” –Ritedose President and CEO Umesh Dalvi
“To see a company like Ritedose choose to continue investing in our state is an important sign to the business community around the world that South Carolina is the place to be. We look forward to seeing the new heights the relationship between our state and this company will reach in the years to come.” –Gov. Henry McMaster
“We’re excited to see the continued success of our state’s thriving life sciences industry. I offer my congratulations to Ritedose Corporation on this tremendous achievement and look forward to supporting them as they grow and prosper in our state.” –Secretary of Commerce Bobby Hitt
“The Ritedose Corporation’s decision to invest in Richland County is further evidence of the attributes of doing business in our community.” –Richland County Council Chair Joyce Dickerson
“Economic development and workforce development are the cornerstone of our mission at Midlands Technical College, and we are happy to partner with The Ritedose Corporation as they expand on our Enterprise Campus.” –Midlands Technical College President Dr. Ron Rhames
FIVE FAST FACTS
- Ritedose Corporation is constructing a new Richland County facility.
- $10 million investment.
- Ritedose is a manufacturer of pharmaceutical products.
- The company will be constructing a new 140,000-square-foot facility at Midlands Technical College’s Enterprise Industrial Campus off Powell Road in Columbia, S.C.
- For more information on The Ritedose Corporation, visit www.ritedose.com