South Carolina company a leader in organ transportation see more
You might not realize it, but there’s a company right here in the Upstate that’s on the cutting edge of organ transplant technology.
Duncan-based Global Transplant Solutions is quite literally named for what they do. They provide the solutions in which organs are transported to medical facilities all over the world for transplant procedures.
In the past four years, Global Transplant Solutions has blazed an innovative trail. They’re supplying a complete portfolio of organ preservation solutions to the Canadian transplant market, they’ve received FDA clearance for two products in the United States market, and there are four more GTS solutions awaiting FDA approval.
The company has been able to do this in a relatively short amount of time thanks in part to the South Carolina Research Authority. The SCRA is a public, nonprofit corporation that supports South Carolina’s innovation economy.
Since 2017, Global Transplant Solutions has received $350,000 in investments from the SCRA-affiliated corporation, SC Launch, Inc., which provides loans and investments to select, South Carolina-based companies across three areas: Life Science, Information Technology, and Advanced Materials & Manufacturing.
“With the assistance of SCRA and many other places, we went forward, raised private money, started the company and pursued FDA approval of our first product, which we got in 2016,” says John Bruens, the CEO of Global Transplant Solutions. “We’ll eventually have seven FDA-cleared products, exclusively geared towards the organ transplant market, and we are the only company on the planet to have anything like that.”
Steve Johnson, investment manager at SC Launch, says their investment in GTS started small but they saw great potential in the company.
“We gave them a very small grant of $15,000 in April of 2017 when we discovered them,” Johnson says. “They were in the world where there is always much, much higher demand than there is supply. So once you have a patient that is in dire need of an organ, it is everything everybody can do to get an organ donor found and then get that organs safely transported to where it’s going to be done. And Global Transplant has the solutions, literally. They make the solutions that the organs are put in during the shipment process so that they will be fully functional when they’re implanted into the patient.”
Johnson says the SCRA and SC Launch are thrilled with the results they’ve seen so far.
“Our relationship is one of communication,” he says. “It’s one of trust and it’s one where we are very closely following their financial situation. It’s been a very fulfilling relationship; that $15,000 grant to help them get started led to a pretty major investment in them and then, a second investment.”
In fact, SC Launch, Inc. recently stepped in again and helped GTS when COVID threw them a curveball.
“In April 2020, the biggest transplant centers like the Cleveland Clinic and the Mayo Clinic basically said, ‘We’re not accepting any more of your solutions from FedEx or UPS,’” Johnson says. “’We want them to be shipped directly in a truck from your facility in the Upstate of South Carolina and delivered directly to our door.’ Well, that was a whole other twist of logistics for them because they’d never done that. They came to us and said, ‘We’ve got to get trucks. We’ve got to hire people. We’ve got to hand-deliver these solutions.”
“There was a concern amongst our customers that standard shipping groups were exposing, through no fault of their own, groups to potential infection,” John Bruens adds. “And the one thing you cannot do when you’re in the organ transplant is accidentally infect somebody. Our solutions are very sensitive; they’re temperature sensitive, they’re not made to be out on tarmacs getting hot. So we needed to figure out how to continue to deliver to these places that absolutely needed our product.”
“Our relationship is one of communication,” he says. “It’s one of trust and it’s one where we are very closely following their financial situation.” – Steve Johnson
Thanks to a loan from the SCRA and SC Launch, the company was able to do just that.
“This company wouldn’t exist if it wasn’t for SCRA and their support,” Bruens says. “We’re always looking for ways to be better, and SC Launch and SCRA helps with that.
“Global Transplant Solutions is a gem of a company,” Johnson adds. “We’re very proud to be associated with them, we’re very proud to have invested in them, and we’re very proud of the work they’re doing.”
According to the United Network for Organ Sharing (UNOS), more than 35,000 organ transplants a year are performed in the U.S. As this article was being completed, GTS announced that the FDA had given clearance to another of their solutions, Servator® P, which is used for safe human lung transportation.
Workforce efforts paying off for life sciences in SC see more
South Carolina’s life science sector creates twice as many jobs as the average of all other sectors in the state economy, according to a recent study, but whether it can fill those positions is another matter — especially in the manufacturing and logistics side of the house.
“It has historically been the majority of the time that you find a qualified person, they already have a job in M&L (manufacturing and logistics), so it has really been tough to fill the need,” said Josh Turner, a sales executive for Modjoul, a health-focused data analytics company that serves the manufacturing sector. Turner is also a former staffing professional.
He added that staffing companies pre-pandemic were filling positions with available people even if they weren’t trained or had any experience in the field.
“All I’ve heard since the pandemic is [that] it has been hard to even find available people, much less available and qualified people,” he said.
This gap is even more prominent in a life science field that sometimes requires more than the standard specialization or training. And to add insult to injury, few in-school training programs target this unique brand of manufacturing and logistics, said SCBIO interim CEO Erin Ford.
“The life sciences encompasses so many aspects from medical devices to pharmaceutical research and development to logistics in getting the drugs or pharmaceuticals or medical devices to where they need to be,” she said. “There's just so many aspects to the life sciences. And we really, as a state, have not focused on having any specific curriculum or programs that are specialized in this area.”
She argued that while the traditional medical careers such as nursing fall under the Life Science umbrella, industrial aspects of the sector often get overlooked in the classroom.
“It’s just not even a part of the discussion as to what career you want to have,” Ford said.
Since the economic development organization formed its Workforce Development Taskforce a few years ago, its more than 300 members have aimed to do something about that.
She hopes that 2021 (or early 2022) will be the year she can see their work come to fruition through a curriculum pilot geared toward two-year students in South Carolina’s technical college network.
Students upon learning about the field may often feel intimidated by the math or science components attached to a traditional science, technology, engineering and math field, she said, but really it’s the requirements of working in a clean room in the medical device field that can prove to be the most challenging.
And that is the gap Ford hopes the program will fill.
So far, Tri-County Technical College, Trident Technical College, Greenville Technical College and Midlands Technical College have signed on to the pilot, she said, which covers a track for pharmaceutical or biotech professionals and those seeking a career in the medical device field.
“We don't want to reinvent the wheel,” Ford said. “That's why we're working with a lot of the partners to add in more substance for life sciences. So if we see that there is more for us to do, we will definitely take that on.”
Life science companies in each region have already offered up some input to their needs and will continue to do so once the program launches: Trident Technical College has its ear to the ground for workforce demands of Alcami, Charles River Labs and Vikor Scientific while Tri-County Technical College is partnering with Arthrex, Abbott Laboratories and Poly-Med. Midlands Tech has an open channel to the demands of medical device companies Rhythmlink and Nephron Pharmaceuticals.
“You’ve seen the map, right? Of the 700 life science companies? The kids just don’t know,” she told GSA Business Report, adding that it’s the job of SCBIO and its partners to share the story of the state’s abundance of life science firms and manufacturers.
Medical device manufacturer Poly-med CEO Dave Shalaby said his company usually hires Clemson University graduates and has a strong in-house program, but now that the hiring climate has become so competitive in the Upstate, he has started to advise Tri-County Tech on courses that would expose students to the industry’s ISO 1345 standards and documentation.
“And really surprisingly, it's not really geared toward the sciences as much as it's geared toward control, like how to control processes and design, and also there's a lot of statistics involved with showing proof that you're adhering to specific specifications that you've set,” Shalaby said. “So basically the course outline that we set up with Tri-County is to give them exposure to those sorts of things.”
Tri-County instructors will teach company and industry requirements, he said, and help create a workforce pipeline to Poly-med, Arthrex and Abbott.
“Tri-County is developing that curriculum now,” he said. “They’ve got sort of a draft in place, and it’s got to come back out for everybody to take a look at it and see if it makes sense to create the course.”
The course would help prime students for employment at partnering industries like Poly-med, and Ford foresees a potential apprenticeship route on a case-by-case basis. SCBIO has been in conversation with Apprenticeship Carolina’s Carla Whitlock on those possibilities.
In the meantime, Ford encouraged other industry voices interested in contributing to the program through input or partnership to get in touch and jump on board.
“Reach out to us,” she said. “Reach out to me and SCBIO, because the more industry that we can have involved in these programs, the more successful it will be.”
SCBIO, 3 life sciences companies highlighted in media reports see more
Courtesy Greenville News/Gannett
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.
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.
Softbox a key player in battle to beat COVID see more
Softbox, a leading global innovator and provider of passive temperature control packaging solutions for the pharmaceutical, life science and cold chain logistics industries, is proud to support Pfizer in the distribution of Covid-19 vaccines through the supply of a high-performance temperature-controlled parcel shipper developed specifically for ultra-low temperature applications.
Softbox supported Pfizer with the development of the highly specialised and reusable ultra-low temperature (ULT) shipper to help them on the distribution of ultra-low temperature vaccines and storing them at Point of Use (POU) sites.
Ultra-Low Temperature vaccines, such as that developed by Pfizer – BioNTech, uses mRNA (messenger RNA) technology and must be stored at temperatures between -90°C to -60°C to ensure that the vaccine’s quality and efficacy is maintained. The ULT shipper is capable of maintaining the required temperature during shipping of Covid-19 vaccines between -90°C to -60°C for at least 10 days unopened.
The highly innovative shipper utilises high performance insulation materials, incorporated in a robust and reusable construction, in conjunction with dry ice, to ensure long term ultra-low temperature control. Based on current guidelines, the Softbox ULT Shipper can be opened twice a day, for up to three minutes at a time. This allows clinicians at Point of Use (POU) sites to access the vaccine vials required for each day’s immunisation clinics without exposing the remaining vaccine stored within the shipper to ambient temperatures, thus ensuring integrity of the vaccine is maintained.
When correctly managed, the ULT Shipper can be used to store vaccines for in excess of 30 days. Through a process called “Re-Icing” the dry ice in the Softbox ULT Shipper can be topped up ensuring maximum thermal protection of the highly temperature sensitive mRNA vaccines.
“Softbox’s extensive knowledge and experience in temperature control packaging solutions and the cold chain industry was the right choice for us. They immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine, 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.” said Tanya Alcorn, Vice President, Biopharma Global Supply Chain for Pfizer. “Their technical capabilities and innovative approach helped us achieve an excellent result in a very short period of time.”
Kevin Valentine, CEO of Softbox, said: “We are immensely proud to be playing such an important role in the fight against Covid-19. We worked extremely hard during 2020 to help Pfizer develop this highly innovative ULT shipper; establishing one of the world’s largest fleets of reusable temperature-controlled parcel shippers in the process and setting up two world-class service centres to support ULT shipper refurbishment.”
“It’s a huge honour to have the opportunity to support the distribution of these vital vaccines at the right temperature, maintain their integrity and help save millions of lives.”
For more information about Softbox visit: www.softboxsystems.com
Softbox is an award-winning temperature control packaging innovator that has been designing and producing high performance passive temperature control packaging solutions for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout Europe, North America, Latin America, India and Asia Pacific.
We have formed long standing partnerships with the world’s leading pharmaceutical, clinical research, biotech and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive clinical trial and commercialised products.
For more information about Softbox visit: www.softboxsystems.com