Softbox Systems the partner of choice for Pfizer vaccine see more
Greenville is the North American headquarters for Softbox, the British manufacturer of the insulated containers critical to the stability of the Pfizer vaccine.
“I consider this the start to the finish as we move into this process of trying to get enough immunity into the community,” Dr. Steve Shelton said as the dry ice-laden Softbox made a triumphant arrival at Prisma Health-Midlands, complete with pom-poms and cheering health care workers. Shelton is an emergency room physician with Prisma Health who spearheaded COVID-19 treatment efforts in the Midlands.
“I know there is a lot of anxiety about this, but I am confident in the FDA in making sure that they have approved an effective vaccine,” he said. “I feel like I am honored to be here to receive this and am doing my part to combat this disease.”
To remain effective, the vaccine must be shipped at temperatures colder than most of Antarctica, in a box with more layers than a Russian doll. The Softbox includes a top layer or “pod” of dry ice housed on top of five trays of the vaccine, which in turn, nests in a carrying box with a foam lid and temperature gauge. All this is fitted in a cardboard shipping container, according to a Dec. 3 manual from Pfizer.
EUA means help is on the way to millions worldwide as the first vaccine for COVID-19 is rolled out see more
The Food and Drug Administration on Friday granted emergency authorization to Pfizer and BioNTech's coronavirus vaccine, clearing its use after a historic 10-month research sprint and a rapid review that culminated Thursday with the endorsement of an independent advisory committee.
With the vaccine's authorization, millions of vulnerable U.S. residents could soon have a shot at protection from a resurgent COVID-19 pandemic that has claimed hundreds of thousands of lives and sickened millions. Daily case counts and deaths have hit new highs in the weeks following Thanksgiving and more than 100,000 people are currently hospitalized.
Initial supplies, however, are extremely limited, forcing public health officials to prioritize which groups should receive the vaccine first. Healthcare workers and nursing home residents, who have fallen ill and died from COVID-19 in disproportionate numbers, are expected to begin receiving the vaccine within days, as Pfizer began manufacturing while clinical trials were still underway.
Some 2.9 million doses are expected to be available initially, with the U.S. holding some in reserve to ensure people receive the second of two doses that vaccination requires.
"While not an FDA approval, today's emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine holds the promise to alter the course of this pandemic in the United States," said Peter Marks, director of the FDA division that reviews vaccines, in a statement.
Authorization of a vaccine within a year of scientists identifying the new coronavirus is a scientific milestone that, at the pandemic's outset, looked unattainable.
"In my wildest dreams, I thought it would be fast. But fast means, if it [typically] takes seven years, maybe you can get it down to a couple of years," said Anthony Fauci, in a Dec. 11 interview with the editor of JAMA. "Now it's our challenge to convince people that this wasn't rushed in a reckless way."
Yet the FDA has been under immense pressure to speed an approval and, on Friday, the Trump administration reportedly told agency head Stephen Hahn to submit his resignation if Pfizer and BioNTech's vaccine was not cleared by the end of the day. The vaccine was cleared by regulators in the U.K., Bahrain, Canada, Saudi Arabia and Mexico earlier this month.
The emergency use authorization, a special type of approval used in public health crises, came one day after a panel of FDA advisers voted 17-4 to recommend use of the shot.
Two of the four "no" votes came from committee members who wanted to recommend the vaccine only for people aged 18 or older, rather than include 16- and 17-year olds as the FDA had advocated. The FDA's final decision authorized its use for people as young as 16.
The regulator, along with its advisers, was persuaded by a massive trial that enrolled 44,000 people and randomly assigned them to receive either Pfizer and BioNTech's vaccine or a placebo.
Trial results announced Nov. 18 showed the vaccine to be 95% effective in preventing COVID-19, easily surpassing the 50% threshold set by the FDA earlier this year. Vaccination was similarly protective in older adults and in individuals of different races or ethnicities, according to detailed data presented at Thursday's meeting.
"The data are pretty clear cut so it's a very straightforward decision," said Philip Grant, an infectious disease doctor at Stanford University Medical Center.
Importantly, Pfizer and BioNTech also proved their vaccine is safe, with no unexpected or serious adverse reactions observed in the study. Many participants did experience injection site pain, fever, headache and fatigue, generally mild or moderate in nature.
While the companies first reported positive results from their Phase 3 study on Nov. 9, they waited 11 more days before submitting an application in order to collect at least two months' of safety follow-up on half of trial participants. Most side effects to vaccines emerge within 40 to 60 days, which motivated the FDA to set the two-month requirement.
Four cases of Bell's palsy — temporary weakness or paralysis in one side of the face — were reported among trial volunteers who received the vaccine, three of which had resolved. FDA reviewers, however, noted the frequency was no greater than what would be expected in the general population.
Regulators in the U.S. and elsewhere are also on now watch for signs of allergic reactions to vaccination among individuals with a history of severe allergies, after two people in the U.K. had reactions after receiving their first shot. The authorization from the FDA instructs medical personnel not to give the vaccine to people who have a history of severe allergic reaction to any of its ingredients.
The emergency clearance for Pfizer and BioNTech's shot is expected to be followed quickly by one for a similar type of vaccine developed by Moderna. An advisory committee is scheduled to meet and vote on the company's application on Dec. 17.
Study results showed Moderna's vaccine, which was developed in collaboration with U.S. government scientists, to be similarly effective against COVID-19.
The shots' high efficacy could help convince skeptical portions of the public who have indicated in polls they'd be cautious or unlikely to get a vaccine.
"There will be less vaccine hesitancy in March than there will be in January, and then a lot less in May than in March," said Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and co-leader of a vaccine trial network.
It's still unclear, however, whether either vaccine can protect against infection and transmission, as well as disease. Data from Pfizer could come soon, however, Kathrin Jansen, the company's head of vaccine research and development, told the FDA's advisers Thursday.
Both companies have worked feverishly to scale up manufacturing in preparation for an approval, but both will only have limited supplies to offer the U.S. and other countries in which their vaccines are approved.
Pfizer and BioNTech, which make their vaccine at sites in Michigan and in Puurs, Belgium, expect to make 50 million doses by the end of 2020, only some of which is reserved for use in the U.S. Production should ramp up considerably in 2021, when the two companies expect to manufacture up to 1.3 billion doses.
Moderna has said it can produce 20 million doses for the U.S. this month, and another 85 million to 100 million by the end of March.
The U.S. initially preordered 100 million doses of each vaccine, an amount that would cover less than a third of the U.S. population. According to The New York Times, the U.S. passed up its chance to order more doses from Pfizer under an option it had negotiated, although officials dispute the Times' account.
On Friday, Moderna announced the U.S. had agreed to purchase another 100 million doses for delivery in the second quarter of 2021. The U.S. also appears to be counting on approvals for several vaccines still in testing by AstraZeneca, Johnson & Johnson and Novavax. Deals with the three companies reserve some 500 million doses for the U.S.
Moncef Slaoui, the scientific leader of the U.S.'s "Operation Warp Speed" vaccine program, recently predicted 100 million U.S. residents will get a vaccine by the end of February — an ambitious target even if two shots are approved.
Further complicating roll-out plans are the temperature requirements for Pfizer and BioNTech's vaccine, which must be shipped and stored at minus 70 degrees Celsius. Pfizer built shipping containers that will use dry ice to keep doses cold, and is handling distribution on its own.
Dry ice has been in short supply this year, requiring logistics companies to beef up production to meet the demand of transporting vaccines.
Moderna's vaccine must also be kept cold, but at a more moderate minus 20 degrees Celsius.
South Carolina life sciences company adding 148 new jobs to booming industry see more
Vikor Scientific, LLC, a molecular diagnostics company, today announced plans to expand operations in Charleston County. The $1 million investment will create 148 new jobs.
Founded in 2018, Vikor Scientific, LLC specializes in antibiotic stewardship and tangible solutions for the practice of value-based medicine in the treatment of infectious disease. The company provides clinicians with advanced molecular methodology for pathogen detection, quantification and resistance gene identification.
Located at 22 Westedge Street in Charleston, Vikor Scientific, LLC's expansion will increase the company's capacity to assemble and distribute both COVID-19 and full molecular panel testing kits across the country.
The expansion is expected to be completed by January 2021. Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.
"The prior backorder of testing supplies was crippling for the U.S. during the beginning of the pandemic, and no one wants to experience that again. This expansion will help us to continue to stay ahead and increase the production of our testing kits for both COVID and our other infectious disease molecular panels by the hundreds of thousands, which is vital as we enter the sick season." -Vikor Scientific Co-Founder Shea Harrelson
"Vikor Scientific, LLC's expansion and the 148 new jobs it will create will have a huge impact in Charleston County and across the state. We couldn't be more excited to continue this partnership and watch them succeed here for years to come." -Gov. Henry McMaster
"Team South Carolina works hard to offer businesses a strong foundation to foster growth and be successful. Vikor Scientific, LLC's decision to expand in Charleston County is an indication that we are doing it right, and we look forward to supporting this great company every step of the way." -Secretary of Commerce Bobby Hitt
"Charleston County offers an environment supportive of innovation, which is a catalyst for our growth in the life sciences industry. We welcome Vikor Scientific's expansion, as it will have a positive impact on our economy with the creation of 148 new jobs." -Charleston County Council Chairman Elliott Summey
"As we continue to respond to the effects of the coronavirus pandemic, the remarkable work of companies like Vikor Scientific has proven critical to keeping our citizens healthy and safe. Not only will this expansion create 148 new jobs in Charleston, but it will increase our ability to provide COVID-19 tests to those who need them throughout the state and across the country. On behalf of the citizens of Charleston, I'd like to thank Vikor Scientific for the lifesaving work they do in our community and wish them Godspeed as they continue to expand operations." -Charleston Mayor John J. Tecklenburg
"Vikor Scientific is a young company making a monumental impact within the life sciences industry, and we are grateful this important work is happening in our backyard. Congratulations to Vikor Scientific on this significant expansion and we look forward to our continued partnership." -Charleston County Economic Development Executive Director Steve Dykes
FIVE FAST FACTS
- Vikor Scientific, LLC is expanding operations in Charleston County.
- The $1 million investment will create 148 new jobs.
- Vikor Scientific, LLC is a molecular diagnostics company.
- Located at 22 Westedge Street in Charleston, S.C.
- Individuals interested in joining the Vikor Scientific, LLC team should visit the company's careers webpage.
SC company to play role in vaccine distribution see more
A South Carolina pharmaceutical company will play a huge role in getting a COVID-19 vaccine to the American people.
Columbia-based Ritedose Corporation announced Thursday it’s been named a partner in Operation Warp Speed and will be responsible for filling and packaging millions of vaccines.
ApiJect, a medical technology company that received $138 million from the federal government to produce the first 100 million COVID-19 vaccines, patented the vial in which the vaccine will be distributed. They needed Ritedose to produce and manufacture those vials with their blow-fill-seal technology.
Ritedose CEO Jody Chastain says more COVID-19 vaccines will be packaged and filled in Columbia than any other place in the country.
“It’s tremendously rewarding,” Chastain explained.
He and his employees did the near impossible, getting two 150,000 square-foot warehouses ready to package and fill the vaccines in only a few months.
“Typically, that would take anywhere from 18-24 months, but within five months, we were able to outfit the facility to be able to handle the vaccine,” said Chastain.
Ritedose has upped its staff by more than 10% to help handle the demand.
“The potential for the workforce here in Columbia is huge, as well as putting Columbia on the map in the response to COVID,” Chastain noted.
The company’s nearly 400 employees also learned Thursday the role they will play in distributing the vaccine.
“It’s been hush-hush around the facility,” said Chastain. “People know that we’ve been doing work around the facility to be able to handle a new product, but they were unaware of what the new product is. Making this announcement to the employees today was very exciting because they’ve been able to see a tremendous amount of pride that’s been able to go into the workforce to be able to handle the vaccine.”
As soon as a vaccine candidate receives FDA approval, Ritedose will work with the company to make sure the vaccine is compatible with their plastic packaging.
“We’re much more efficient,” said Chastain. “We can produce a higher volume in a shorter time period.”
Once the vaccine is rolled out, front line workers, like Prisma Health Baptist Parkridge doctor Jennifer Risinger, will be the first in line.
“I’m very encouraged that we’re looking at months instead of years,” said Risinger.
She says she and her colleagues are eager to get the vaccine.
“It does give us a sense of relief and confidence that we’ll be able to deliver the care that people here in the Midlands deserve,” she noted. “I think we should all be very proud that we have a local company who is this involved in bringing this to the national spotlight as soon as possible.”
Ritedose says it’s likely the first vaccines distributed in South Carolina will have been packaged and filled in Columbia.
Operation Warp Speed has a goal to produce and deliver 300 million safe and effective doses of the COVID-19 vaccines, with the first doses expected to be ready by January 2021.
Nephron prepping to fill COVID vaccines in state see more
LEXINGTON COUNTY, SC (WSPA) — With a potential COVID-19 vaccine looming, one South Carolina company said they’ll be able to fill vaccines next year.
According to Nephron Pharmaceuticals CEO and Founder Lou Kennedy, the company is in the midst of a $215 million expansion. They are adding new office and new warehouse space. The investment will also create more than 380 jobs the company said.
The expansion also includes vaccine production space. Kennedy said once completed, they’ll be able to fill COVID-19 vaccines at their facility.
“We’re actively looking for the right partner that will produce and we’ll fill the vaccine. We’re speaking with people throughout the federal government and Department of Defense to find the right partner,” Kennedy said.
Tuesday, the company held a beam raising ceremony to celebrate their expansion. Kennedy said she expects to have the vaccine production space completed by March 2021.
As of Tuesday afternoon, the FDA has not approved a COVID-19 vaccine for distribution. However, preliminary reports on vaccines from Moderna Inc. and Pfizer Inc. show their vaccines have at least a 90% effectiveness rate.
Kennedy said they are anticipating a medical grade glass shortage because of the high demand for the vaccine. She said they have the ability to work around that. “Our option will be to put the vaccine in plastic. We have the technology and the capability.”
Under the South Carolina Department of Health and Environmental Control’s (SCDHEC) statewide vaccine plan, front line medical personnel and nursing home residents will be some of the first South Carolinians to get doses of an approved vaccine. They anticipate vaccine supply will be limited to start off, but Kennedy hopes they can help alleviate that.
She said, “We’re right in tandem with the research work and the clinical trials that are going on. We’re trying to time that perfectly for the vaccine filling side of it.”
Companies find ways to thrive despite pandemic see more
Seven months ago, John Carrington took a deep breath and pushed all his chips to the center of the table.
His Columbia company, ZVerse, was at a crossroads. Founded in 2013 as a 3D design and software solutions provider, the Shop Road outfit faced overwhelming demand for the protective face shield that had grown from an idea hatched to help local hospitals into orders multiplying into the millions.
“The first request we had was for 3,000 units, which we could solve, no problem,” Carrington said. “The next day it was 10,000, and the next day it was 50,000, and at that point we knew that 3D printing would not be able to keep up with that demand. … We had to place a bet.”
The wager involved shutting down for a few weeks to completely retool ZVerse’s production process to injection molding while scaling up from an 8,000-square-foot facility to a 30,000-square-foot one that could fill three tractor-trailers a day. Continue reading by clicking here...
Cold storage for vaccines could be an issue see more
News last week that a COVID-19 vaccine has shown a 90 percent success rate in testing has buoyed hopes that the coronavirus pandemic might soon be under control, but getting that vaccine to patients promises to be a logistics challenge.
The vaccine, developed by Pfizer Inc., has to be stored at temperatures of at least minus-94 degrees Fahrenheit. That’s approaching the lowest temperatures at the South Pole.
It’s also much lower than the temperatures experienced in typical cold-storage logistics. The refrigerated cargo containers that move through the Port of Charleston can achieve temperatures of below-30 Fahrenheit, but that fluctuates during summer months when outside temperatures are climbing. The coldest refrigerated container built by industry leader Thermo King can reach minus-76 Fahrenheit, but that’s still not cold enough for vaccine storage.
Zverse a hit on Amazon see more
The country's largest producer of branded face shields has made its top-selling products available for purchase on Amazon.
Earlier this spring, digital manufacturing company ZVerse created a first-ever PPE product to be marketed and sold directly to consumers: The ZShield, an ultra-lightweight, neck-mounted face shield designed to provide a comfortable, wearable barrier that helps users shield their face, mouth and eyes from spray, splatter, and the direct transfer of respiratory droplets. ZVerse has since produced over four million face shields, and now, several of its products are available for purchase on Amazon, marking another milestone for the company. All products are made in the USA.
"At the height of the COVID-19 impact on the U.S., we recognized our unique ability to quickly produce and provide valuable PPE to our front-line healthcare heroes, while also creating jobs and stimulating the local economy," said John Carrington, founder and CEO of ZVerse. "We have since grown our PPE product pipeline to serve a number of industries. We owe a tremendous amount of gratitude to our partners and customers for helping us reach this milestone with Amazon."
Shoppers on Amazon now have access to four ZShield models, including the ZShield Health, the ZShield Flex, the ZShield Wrap and the ZShield Youth. ZShields can be purchased individually and in packs of two or five. Replacement shields for both the Flexand Wrap are also on sale in quantities of five or 10.
Based on industry and customer demand, ZVerse creates face shields that provide a threshold of hygiene for those seeking options for face coverings. ZShields allow for clear verbal and nonverbal communication and all-day comfort when masks or stationary sneeze guards are not practical, or when environments call for the use of both a shield and a face mask. The ZShield has completely disrupted the industry, bringing much-needed design innovation to the world of PPE and earning ZVerse a 2020 Innovation by Design Award from Fast Company. ZVerse is now producing hundreds of thousands of ZShields a day, which are all designed, sourced and made in the USA through an established domestic supply chain.
Moderna vaccine results looking very good early see more
The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.
Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.
Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.
Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.
News you can use about SC life sciences see more
Catch up on all the important reading around South Carolina life sciences -- and the national and global issues impacting it. It's all here, easy to read in just a few minutes, with dozens of helpful links. Enjoy!
Vigilent Labs to call Charleston, South Carolina home see more
Compliments of Charleston Post and Courier
Congratulations to our colleagues in Charleston County for this excellent announcement, advancing the growth of life sciences in South Carolina. Read the full story here.
A technology firm with ties to the U.S. defense industry said Thursday it will invest nearly $105 million in a facility on the former Navy base in North Charleston that the company says will manufacture COVID-19 test kits.
Vigilent Labs said it will hire 400 workers to produce FDA-approved test kits that can detect COVID-19 antibodies and antigens in 10 minutes or less.
Manufacturing will begin in December and the company said it also will move its headquarters to the site at 1105 Truxton Ave. Vigilent is currently based in Alexandria, Va., near the nation’s capital, and it was incorporated in Wyoming. Read on for full details.
Zverse steps up for South Carolina see more
John Carrington remembers the chaos from the spreading coronavirus reaching his small Columbia, S.C., company about Saturday, March 14, three days after the World Health Organization declared Covid-19 a pandemic.
It started with a phone call from a hospital executive that Saturday saying the hospital was running critically short of personal protective equipment (PPE), ventilator parts, and ventilators altogether. “What can you do?,” the hospital executive asked.
The Zverse CEO recalled that the executive “was pretty urgent,” and the gist of the message was open-ended: “We need a lot of problems solved and fast, and how can you help?”
How indeed? Carrington couldn’t offer the hospital a catalog of PPE, or a catalog of anything.
His workers were specialists in being manufacturing enablers, providing software and a cadre of experts who linked customers with ideas with manufacturing partners to convert those ideas into objects as quickly and efficiently as possible.
Within days, the company would shift into designing its own face shields for use in hospitals, later designing other models for schools or other crowded spaces.
Zverse would go from being able to make 1,000 face shields a day using 3-D printers to making the heavy investments to build molds for injection molding that allowed its production rate to climb to 120,000 units per day within about a month. That process would typically take about two or three months.
In March, Zverse had 20 employees. By September, it had 80. It expects to end the year with 100 to 120 employees — more designers, product managers, account managers, customer service and support, shipping and logistics specialists.
“It’s been a wild ride,” Carrington said.
Zverse is just one of hundreds of South Carolina businesses that were called to action by the pandemic and responded with innovations to help their customers and communities in a time of need. Several of those companies in the biotech field were highlighted in an Aug. 25 webinar by SCBIO, a not-for-profit industry association promoting the life sciences in South Carolina.
The others were:
VitaLink Research, a clinical research site network based in Greenville. VitaLink was commissioned by Moderna to conduct its Covid-19 vaccine study in South Carolina.
Vikor Scientific LLC, a Charleston testing laboratory founded in May 2018 by physician and entrepreneur Shea Harrelson and medical entrepreneur Scotty Branch. Its lab is accredited by the Centers for Medicare and Medicaid Services under its Clinical Laboratory Improvement Amendments (CLIA) certification. They have dedicated 2,000 square feet of its new 22,000-square-foot facility to Covid-19 testing. In late August it was testing about 10,000 Covid-19 swabs per day, and had the capacity to test for 20,000 per day.
Nephron Pharmaceuticals Corp., a West Columbia manufacturer of medical products and a leading producer of medical products packaged into single doses using blow-fill seal technology. It is creating space at its Lexington County plant to manufacture vaccine doses when they become available. Since the pandemic, it has created a CLIA-certified lab for Covid-19 testing, and has a mobile lab that visits the University of South Carolina and several area employers.
Modjoul Inc., founded in Clemson in 2016 by Eric Martinez, CEO, and Jen Thorson, COO. Modjoul sells a platform designed to enhance worker safety by having them wear a device called a SmartBelt that tracks their movements. Linked software identifies movements that might be dangerous — from certain bending movements to overly fast cornering with a forklift. With Covid-19, it is enabling employers to use the devices to screen body temperatures and signal workers with a vibration if they are violating social distancing. In the event of an outbreak, the data can be used for rapid contact tracing.
“When you think about it, you’re able to reduce the amount of time businesses are shut down because you know who people have been in contact with,” Thorson said. “It’s one of those happy coincidences that we’re able to use our existing device, not only for safety, but also for that illness, contact tracing and social distancing.”
Thorson said her biggest lesson from the pandemic has been “don’t be afraid to pivot quickly.”
“We have a team of really smart people, and we can figure out almost any problem,” she said.
At Nephron Pharmaceuticals in Lexington County, one of their biggest lines is generic inhalation solutions and suspension products, including those used to treat severe respiratory distress symptoms associated with Covid-19.
The company has grown from 75 employees with two products in 2001 to about 80 products and about 1,100 full-time employees, in addition to 900 part-time workers, interns and apprentices. It announced an expansion this year that will expand its buildings to cover 1 million square feet by early 2021. It expects to add 380 more full-time employees by 2024, and much of the hiring is now underway.
“We want them to be trained and ready as the new buildings come online,” CEO Lou Kennedy said.
About 110,000 square feet of its expansion is for manufacturing vaccine doses, antibiotics or other chemo-therapeutic agents. Nephron Pharmaceuticals is one of seven U.S. companies identified by the federal government as key to getting a vaccine produced — once one has been developed.
“We know we’re going to need a heck of a lot of vaccines all at once if we’re going to get everybody healthy,” she said. “We are doing anything we can within our bandwidth to be patriotic Americans and help with the eradication of Covid-19.”
The New York Times first reported Jan. 8 on the emergence of a novel coronavirus in China’s Wuhan province. Two days later, China reported its first death from the virus.
The first case in the United States was confirmed Jan. 21.
On Feb. 11, the World Health Organization named the disease Covid-19.
By Feb. 26 there were 60 known cases in the United States, and Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, asked the American public to brace itself for a global pandemic.
That day President Trump said infections were “going very substantially down,” and that “we’re going to be pretty soon at only five people.”
Just two weeks later, when Covid-19 was declared a global pandemic, there were at least 1,240 people in 42 states and Washington, D.C., who had tested positive for Covid-19, and 37 had died.
Meanwhile, a wave of change was rolling toward Carrington’s 7-year-old company on Shop Road, named for its location by Columbia’s Norfolk-Southern railroad repair shops and better known for parking for UofSC football games.
His children were home from school, many offices were closing and employees were working from home — if at all.
“It was interesting,” he said. “We were not sure what this meant for us, let alone as a business, because a lot of our manufacturing customers’ factories shut down as well.”
After the weekend call from the hospital executive, Carrington tried to solve its first problem: The hospital needed fully protective face shields that could be worn in the intensive care unit, or other areas with dense aerosols.
“Literally overnight, we went from concept to prototype, rapid prototyping, multiple iterations,” Carrington said. “They were asking for 3,000 units, which was no problem. And they needed them immediately.”
The next day, Zverse got a call from a government agency that needed 10,000 face shields. And on the third day, another hospital system called needing 50,000 shields.
The second hospital system needed face shields that could be sterilized and reused because they were going through disposables at a rate of 5,000 per day for just one of its hospitals.
While 3-D printers are splendid devices for fast turnaround and multiple design changes, they are not designed for a lot of volume.
And 50,000 units is what Carrington defined as “a lot of volume.”
So, it was decision time.
More calls were coming in. “Once the word got out to a few people, we started getting direct messages from doctors, family members of nurses, who were all pleading for help, because there was no PPP at all,” Carrington said.
The mulling was not a long process. The company simply wouldn’t be able to keep up with demand using 3-D printers.
So after the call for 50,000 units, Carrington decided to move from the 3-D printing underway to injection molding, “which was a significant step, because it was a real capital investment during a time when everything was very uncertain.”
But he knew it would also allow Zverse to ramp up much more dramatically, “help a lot more people, help the company and give us a little bit more security.”
The actual injection molding would be done by outside manufacturers, but Zverse had to supply them with the molds.
According to Rex Plastics of Vancouver, Wash., an injection mold can cost $1,000 to $80,000 depending on size and complexity. A typical mold costs $12,000.
Zverse dealt with the issue by requiring its customers to pay half the cost up front. Hospitals typically pay net 30, or 30 days after invoice, but they quickly agreed. “These are different times,” Carrington said.
“We were able to get the first 5,000 units coming out of the first mold within about two weeks.”
In all, Zverse built about 24 tools for injection molding.
Carrington credited much of the company’s success to its network of manufacturers.
“We had all the right people in our ecosystem to accomplish all this.
“We sit in the middle of a lot of manufacturing capabilities. That’s what we’ve done forever,” he said. “This is the first time we took a product of our own and went to market with it.”
After injection molding was in place, Zverse spread the word that it had the capacity to make 100,000 units a day — mass manufacturing.
“We got flooded with orders from every hospital, every government agency you can imagine,” he said. “It was completely overwhelming.”
Carrington started calling his shareholders and others in his support network to solve emerging problems, like transportation logistics.
“That whole period was insane for everyone involved,” he said. “But it was super fulfilling.”
One of Zverse’s biggest contracts was for the U.S. Department of Veterans Affairs for 2 million face shields. At the time, there were reports about suppliers not being able to deliver equipment and PPE to the VA.
But Zverse supplied the order from April through June.
“That was a herculean effort to be able to deliver that on time,” he said. “The VA said we were one of the best suppliers that they had.”
In all, Zverse supplied 3 million of its health model ZShields over 75 days.
As businesses began trying to reopen in May, there was a broad need for some forms of barriers and PPE —a need that is likely to last beyond the pandemic.
Some restaurants called for the face shields Zverse was delivering to hospitals.
“I looked at them and said if I walked into a restaurant and saw someone wearing this, I wouldn’t want to eat there. That’s going to be bad for business,” he said.
Instead, Zverse designed ZShield Plex —something that would be a comfortable and effective barrier from transferring droplets from your mouth. The shield attaches at the neck and can flip down when on break or away from where needed.
“That one captured everyone’s attention,” he said.
Zverse started taking pre-orders for the shield in May from businesses, schools and others, and has since shipped millions.
Carrington said Zverse was able to make its huge pivot to meet the demands of the pandemic moment with “brute force and an incredible team.”
“The core group that’s been here since March has been averaging like 16-hour days since March, including weekends,” he said. “Everyone is driven by the fact that we’re able to produce something that is able to solve problems.
“Right now the world needs a lot of problems solved,” Carrington said.
“I don’t think there’s been a time in history when the world has needed as much innovation in one moment as it does right now.”
Greenville's Humimic Medical pivots to meet pandemic needs see more
When the coronavirus pandemic left businesses around the nation struggling with dwindling orders and growing bills, some took a chance on something new.
Among them was Greenville-based Humimic Medical.
The 10-year-old company produces synthetic gels that mimic human tissue used in medical applications. Almost overnight, it switched to producing personal protective equipment (PPE), illustrating that there are opportunities everywhere for people with innovative ideas.
But it wasn’t all smooth sailing and the path was punctuated by a couple of Hail Mary passes, said Humimic founder and CEO Joel Edwards.
“None of our (products) had any ties with PPE or any Covid-related things … and everything was going pretty well,” he said. “We thought we were bulletproof.”
Then the phones stopped ringing, he said. There were no orders for three months.
Edwards spoke at the first of a series of webinars called “Leading Beyond the Crisis” that examines companies that responded to the pandemic. The webinars are hosted by InnoVision Awards, a grass roots non-profit dedicated to innovation and technology across the state.
Originally a defense industry company, Humimic began to focus on the medical side about four years ago, he said.
And in the face of the virus, it started looking at what else it could do, he said.
Since the company had a plastics supplier in Mount Pleasant and had just bought some new equipment, it turned to face shields when the virus exposed the desperate need for PPE, he said.
“We thought raw product (plastic, foam) was easy to come by, but when we started looking around, none were easy to secure,” he said. “And I’m running numbers in my head and thinking what did I get myself into.”
His contact in Mount Pleasant was his “only saving grace.” Then the elastic supply dried up.
“So we said, heck, Velcro is readily available,” he said. “And we started to get as much as we could get our hands on.”
The first shield the company made had straps that weren’t long enough to fit most men’s heads, he said. But once that problem was solved, it did an initial run of 500, he said.
Company officials thought they’d sell their shields for $4 to $4.50, he said. But with the Chinese selling theirs for $2 to $3, he wondered how the company could potentially make a profit and keep everyone employed.
“It was a hard thing for us to get people to understand. We were not looking to gouge the market and get rich,” Edwards said. “But our cost for the plastic was two to three times what Chinese were charging.”
In the end, he said, with no assembly line experience, the company had to produce 1,500 a day to make about $1 profit per shield.
“We knew price was going to be a hard thing,” he said. “The only way we were able to do it was to scoop up the plastic.”
As other suppliers ran out of stock, Humimic found markets at veterans’ centers, VA hospitals, dentist offices, nursing homes and mortuaries.
In the end, the company was able to produce some 80,000 shields sold around the country on Amazon and Walmart websites, Edwards said.
He said Humimic still has several thousand shields in stock, but it came out OK even though orders for PPE are slowing down.
If Covid flares up this winter, he said, the need might grow again.
Nephron employees achieve Lean Six Sigma green belt certification see more
If there were ever a time for improved efficiency to help a fast-moving company, it would be now for Nephron Pharmaceuticals Corp.
With the West Columbia-based manufacturer of sterile respiratory medication churning out product at a record pace during the COVID-19 health crisis, owner and CEO Lou Kennedy is in search of every competitive advantage available.
“In spite of my Southern accent, I do move like a New Yorker, and this company goes at that pace,” she said. “It’s a testament to the team here that everybody’s running on high-test, premium unleaded, and keeping up.”
The most recent example came when nine Nephron employees achieved Lean Six Sigma green belt certification after completing courses at the University of South Carolina’s Darla Moore School of Business. Six Sigma or lean manufacturing, pioneered by the likes of Henry Ford and famously implemented by Toyota in the years following World War II, is a systematic method aimed at reducing waste and variation to improve production quality and efficiency.
Zverse honored in national competition see more
Columbia-based digital manufacturing company ZVerse has won a national design award for its ZShield Flex.
The ZShield, designed and manufactured by Columbia-based ZVerse, has won a national design award for innovation. (Photo/Provided)
The face shield, designed and produced by ZVerse, has been named an Innovation by Design Awards winner by business magazine Fast Company. The awards, in their ninth year, recognize creative, problem-solving innovations and have included winners such as Spotify, Google and Disney+.
The shields feature lightweight visors that clip around the wearer’s neck, making the shield comfortable for all-day wear. ZVerse’s computer assisted design platform creates custom, manufacturable 3D files that are returned to clients for production, enabling an invention to quicky go from idea to reality.
“We need innovative design more than ever, and the 2020 honorees have brought creativity, inventiveness, and humanity to address some of the world's most pressing problems, including the global pandemic, racial injustice, and economic inequality,” Stephanie Mehta, editor-in-chief of Fast Company, said in a news release. “Together these entries offer a glimpse into a future that is more inclusive, more accessible, and more just.”
The ZShield Flex won in the Workplace category and also received an honorable mention in the Best Design of North America category alongside companies such as Microsoft, Google and Logitech. A complete list of winners, finalists, and honorable mentions are featured online and in the October-November issue of Fast Company, on newsstands Oct. 20.
In March, ZVerse founder and CEO John Carrington adapted the company’s business model to accelerate the mass production of face shields in response to a health care community struggling to deal with the COVID-19 health crisis. The company tested more than a dozen designs before settling on the ZShield, focused initially on the needs of health care workers before being adapted in partnership with industrial designer Scott Henderson for everyday use.
“At the onset of the pandemic, we recognized our unique role in the world as great enablers of digital manufacturing, and we pivoted to become one of the largest producers of face shields to serve our country’s urgent need for PPE,” Carrington said in the release. “After launching with ZShield Health, we brought on Scott Henderson to reimagine the traditional face shield design and create a product that would be comfortable for a variety of work environments as well as everyday life. Going to market with such a novel design and seeing it in use by so many people and industries has been a humbling experience. We’re honored to be recognized by Fast Company for our work; it’s truly been a labor of love.”
To date, ZVerse has produced more than four million shields, nearly tripling its workforce. Notable users include television and film production companies, Disney, Chick-fil-A, Four Seasons Hotels and Resorts, and Walgreens, according to the release.
“When ZVerse originally contacted me about collaborating, I immediately realized how historic this moment was and felt an urgent need to help with the project,” Henderson said. “Prior to COVID-19, face shields weren't considered an essential accessory outside of the healthcare and medical science industry. After a century of little innovation in regard to face shield design, I am so proud of our team for applying out-of-the-box critical thinking to create this new option for PPE.”