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Nephron, ISPE Foundation Announce Diversity Internship Initiative

WEST COLUMBIA, S.C. – The ISPE Foundation and Nephron Pharmaceuticals Corporation announced a partnership on the ISPE Foundation Diversity Internship Program’s newest cycle to provide world-class opportunities to groups that are typically underrepresented in the pharmaceutical industry.

Established December 2020, the pilot ISPE Foundation Diversity Internship Program received a strong response from applicants. This series with Nephron will be a 12-week experience that offers graduate and undergraduate students in their junior or senior year the opportunity to spend the summer working on priority projects for one of the fastest-growing pharmaceutical companies in the country.

“I am delighted and honored to announce the partnership of Nephron Pharmaceuticals with the ISPE Foundation on its Diversity Internship Program,” said Antonio Moreira, PhD, ISPE Foundation Board Chair, Vice Provost, Academic Affairs, University of Maryland Baltimore County. “Over the coming years, a diverse pool of very talented students will be engaged in a variety of technologically stimulating projects under the guidance and mentorship of Nephron Pharmaceuticals scientists and engineers. These life changing experiences will inspire the interns to continue pursuing the many career opportunities that the pharmaceutical industry offers to these future leaders.”

“We pride ourselves on two things: first, we do everything we can to make sure that everyone has a chance to achieve their dreams, and second, we utilize interns and apprentices in everything we do – they are playing key roles in our expansion and growth,” said Lou Kennedy, CEO, Nephron. “This is why I am so excited to partner with the ISPE Foundation to rollout these new internship opportunities. They represent a win-win – for participants and for our company. We are proud to invest in talented young people, and we are excited they want to invest in us. We cannot wait to get started.”

There are currently multiple internship opportunities through the ISPE Foundation-Nephron partnership, including in the following departments:

•    Analytical Services and Formulation
•    Molecular Biology
•    Engineering

The individuals participating in these internships will play key roles in Nephron’s ongoing projects. They will work directly with the entire Nephron team. And they will make a difference for patients across America.

The deadline to submit is 6 May 2021. To learn more, please visit ISPEFoundation.org/Diversity-Internship-Program

About ISPE and ISPE Foundation
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its 18,000+ Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. Founded in 2017 as the philanthropic arm of ISPE, the ISPE Foundation supports education, training, and research for the advancement of innovative technologies and provides solutions to global challenges in the development, manufacture, and supply of quality pharmaceutical products for the benefit of patients around the world. To aide in this endeavor, the Foundation focuses on initiatives related to increasing the technical knowledge of the incoming workforce, fostering diversity within the industry, and supporting efforts to bring quality pharmaceutical manufacturing to new markets. Visit ISPEFoundation.org for more information.

About Nephron Pharmaceuticals Corporation
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.

Inquiries related to the program may be directed to Foundation@ISPE.org. 
 

In celebration of Women’s History Month, Creators Wanted and Nephron hosted a virtual event series: “Creators Stories: Women Make Manufacturing.”

Nephron hosted an event for Creators Wanted in celebration of Women’s History Month: “Creators Stories: Women Make Manufacturing.” The virtual event was designed to bring a message of opportunity and empowerment, with leading women in the industry sharing insights about their manufacturing careers.

Read more on the Creators Wanted website.

ICYMI: How South Carolina life science firms are impacting the COVID-19 vaccination campaign

BY MARCUS NAVARRO
To read the entire story, visit www.greenvillenews.com.

As the distribution of COVID-19 vaccines have ramped up in recent weeks, life science firms in South Carolina have pivoted to play a role in the vaccination campaign.

After weeks of only 60,000 dose allocations in January, that figure has doubled with over 130,000 first doses expected to arrive in South Carolina this week.

The brands are well known — Pfizer, Moderna, Johnson & Johnson — but lesser known companies have played a role in the clinical trials and ancillary supplies critical to the rollout of the vaccine and some are found in the Palmetto State.

Gov. Henry McMaster celebrated SCBIO, a life sciences non-profit, and the industry in February for their great year. Part of that success was in response to COVID-19.

“While 2020 will forever be remembered as the year of an unmerciful global pandemic, our stakeholders heroically rose to the challenge,” Sam Konduros, SCBIO’s president and CEO, wrote in the non-profit’s 2020 report.

SCBIO and over 100 industry firms supported pandemic efforts such as distribution of personal protective equipment — which includes creating an online PPE exchange portal — creation of a jobs portal, testing and promoted proper mask use on social media.

That list now includes COVID-19 vaccines research and packaging, and potentially its production.

Clinical trials vital to vaccine development

The Moderna vaccine was authorized for emergency use on Dec. 18 after clinical trials proved its effectiveness and safety. VitaLink, a Greenville based research company, played an important role in Moderna’s phase 3 trials.

South Carolina had four Moderna phase 3 clinical trial locations out of the nearly 100 locations around the country. Three trial locations — Anderson, Greenville and Spartanburg — were conducted by VitaLink Research, a South Carolina based research company which specializes in respiratory medicine.

“It really was just a natural fit for us,” Steve Clemons, VitaLink’s CEO and president, said.

Clemons expected roughly 400 participants through the three sites but the Upstate had roughly 1,200 of the 30,000 enrolled participants nationwide.

“There should be an awful lot of pride to the Upstate because, frankly, we as VitaLink couldn’t have done this without the volunteers,” Clemons said.

Participants were enrolled in the summer and either received the drug or a placebo.

One of these participants was George Acker who has learned since talking with The News in November that he got the placebo — to his surprise.

The studies were unblinded in January and those who received the placebo were able to get the real vaccine.

Acker has received both shots since then.

VitaLink continues to conduct monthly follow-ups with participants for two years to track side effects, safety and efficacy of the vaccine.

Nearly 400,000 doses of the Moderna COVID-19 vaccine have been administered in South Carolina in the last three months.

The Moderna product has played a vital role in vaccinating long-term care facility residents and staff as initial allocations were given to these populations.

Clemons is proud that VitaLink has played a part in the solution to the pandemic but also in their work in general.

“I get to treat people every day using, kind of, tomorrow’s therapies,” Clemons said. “And I get paid to do it and patients never get billed.”

Packaging of Pfizer vaccines

The Pfizer-BioNTech vaccine requires ultra cold storage, around minus 70 degrees Celsius. This makes shipment a little more challenging but a local packaging company had the solution.

Softbox Systems, a British company with North America headquarters in Greenville, has over two decades of thermal shipping experience.

They supply ultra-cold temperature shippers which keep vaccines between minus 90 and minus 60 degrees Celsius for at least ten days unopened with the use of dry ice and insulation. If managed well, these reusable containers can store vaccines for about a month by re-icing the dry ice.

“[Softbox] immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine,” Tanya Alcorn, Pfizer’s vice president for biopharma global supply chain, said in a March 10 press release. “And quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.”

One of two manufacturing centers supporting the vaccine distribution is located in Greenville, the other is in the Netherlands.

“Our Americas headquarters in Greenville features a full qualification testing lab, product engineering capabilities, and a world-class team,” John Hammes, Softbox’s general manager of the Americas, said. “All of which helped us support Pfizer in the fight against COVID and develop a way to successfully distribute a vaccine to support the global community.”

Vaccines could soon be filled in the Lowcountry

Lou Kennedy didn’t expect on her company would be filling vaccines, but she also didn’t plan on the pandemic — no one did.

In addition to helping with COVID-19 testing efforts, she thought Nephron Pharmaceuticals could take it a step further and help with the vaccinations.

“We have the type of equipment already in our possession, we will have it retooled,” Kennedy said. “We’ll build a wing and it is our sincere desire to find a vaccine partner — like Moderna, Pfizer or Johnson & Johnson — and say, let us fill some of the capacity that the American patient needs.”

The Lexington County-based company is currently undergoing a $215 million expansions which includes a 110,000 square foot vaccine production space. Kennedy expects at least 380 new jobs with the expansion.

About 300 of those could be centered around the vaccine production and she hopes to partner with a COVID-19 vaccine manufacturer to fill vaccines and help ramp up vaccine supply.

Nephron is currently working to find a vaccine partner. It could be Moderna, Pfizer, Johnson & Johnson, or it could be another brand who could receive authorization in the U.S., Kennedy said.

“Between now and the time we move in there, there could be 10 new ones, so we’re keeping our eyes and ears open,” Kennedy said.

They’ve already hired about half the people they need. The building is still being worked on but once it’s completed, Kennedy believes the production lines could be operational by the summer.

The expansion, originally announced in July, will also include a new office, a new warehouse, expanded secondary packaging operations and a 20,000 square foot machine shop.

In the meantime, Nephron Pharmaceuticals already partnered with Dominion Energy to set up a drive-thru vaccination site in Lexington County in February.

“I had this idea that why can’t we help the vaccination,” Kennedy said. “We have nurses on staff and we have [doctors of pharmacy].”

Dominion Energy provided the space and set up a temporary power pole for Nephron’s nurses and staff. They also enlisted the help of Rick Lee, a Department of Environmental Control board member from Rock Hill, on how to best setup a drive-thru clinic.

Like health systems across the state, Nephron is running this clinic out of their own pocket. Vaccines and ancillary supplies are supplied by the government, but staff and other costs are not.

“We’re not getting reimbursed for any of this,” Kennedy said. “We’re doing this out of the bottom of our heart.”

The drive-thru site has ramped up from about 30 vaccinations per day when it first opened to about 150 vaccinations per day by March. Kennedy hopes to get this up to 300 per day.

News 19 WLTX: Nephron sees interest in vaccination drive-thru rise as Phase 1b opens

Read the entire story from News 19. Watch

WEST COLUMBIA, S.C. — Nephron Pharmaceuticals saw an increase in the number of people interested in signing up for an appointment as Phase 1b opened up on Monday.

For the past month, the company has partnered with Dominion Energy to open up a drive-thru vaccination site. It’s located off of Exit 2 on Interstate 77 in West Columbia.

The site is open Monday through Friday from 10 a.m. until 3 p.m., with vaccinations available by appointment only.

Frances Musselwhite, who lives in Aiken, traveled to the site to get her second dose of the vaccine. Initially, when access to the vaccine was hard to find, she said getting an appointment at any location in Aiken was a nightmare.

“I’m in Aiken County and Aiken had absolutely no vaccine in the entire time that I was looking,” Musselwhite said. “I just kept hunting and hunting, and finally a friend of mine called me and said I just heard that this is opened up.”

While she’s finished with the vaccine process herself, she’ll be coming back on Friday to help schedule an appointment for her mother since they couldn’t get appointments on the same day. 

Musslewhite says everything has been fine with her vaccination experience with Nephron and the people have been sweet.

William Hogan lives in the Midlands. He also received his second dose of the vaccine on Monday.

“I don’t want COVID,” said Hogan. “I think it’s important for everybody to come out and get it if you don’t want to get sick. If you just want to chance it … I know a lot that are. I didn’t feel like being one of them.”

When people drive up to get the vaccine, they will stay in their car throughout the whole process. Once people check in at the front, they’ll drive to the vaccination site to receive the vaccine from a registered nurse and they’ll pull over to another area to wait 15 minutes to make sure someone is not having any allergic reactions to the vaccine.

During the 15 minute wait period, people will be able to schedule their second dose of the vaccine.

Stephanie Simmonds, Chief Clinical Officer for Nephron Pharmaceuticals, says everything has been going well since they opened up the site.

“We’ve increased our volumes every day. We’ve been able to get more vaccine from DHEC sent to us. We just received another shipment this morning,” said Simmonds. “We’re ready to take on the Phase 1b.”

The Chief Clinical Officer says they’ve been able to schedule appointments that don’t require people to wait a long time in line at the site.

Nephron is able to vaccinate around 200 people each day. They’re hoping to increase that number to 300.

On Monday, those in Phase 1b were able to start receiving their coronavirus vaccine.

“Today we’ve had a rapid increase in calls into our call-center,” Simmonds said. “Lots of interest that’s getting communicated. People are able to get in touch with us. We have a call center to manage those calls so we’re able to answer everyone as quickly as we can and provide the information they need.”

Simmonds says they’re glad they can do their part to help vaccinate the community.

“We just really want to make it available for South Carolina and open up to be able to vaccinate as many people as possible,” said Simmonds. “We knew that as a manufacture, we’re good at process flow and we’re able to implement good ways to get people through in and out in a safe manner and we wanted to make that happen.”
 

Clemson, Nephron driving pharmaceutical manufacturing with new benchtop industrial robot

The entire story is available at Clemson’s website.

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.
 

Nephron CEO Lou Kennedy Named to National Association of Manufacturers Board of Directors

WEST COLUMBIA, S.C. – 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.

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