Portal sees surge in traffic see more
In early March, Thornton Kirby, president and CEO of the S.C. Hospital Association, raised an alarm that South Carolina may face a shortage of personal protective equipment.
The message circulated through a number of economic development groups, along with surveys probing retooling capabilities in response to the Trump administration’s invocation of the Defense Production Act.
As manufacturers geared up across the state to meet critical needs, the S.C. Hospital Association, SCBio, the S.C. Department of Commerce and the S.C. Manufacturing Extension Partnership joined forces to connect healthcare providers and other industries with critical needs equipment through the S.C. Emergency Supply Collaborative portal announced April 13.
Kirby said the portal will help streamline the product’s trip from the manufacturer to the hospital. He hopes other sectors, such as auto assembly, construction and education, will be able to make use of the portal to replenish their equipment stores, too.
“There are some who are on a two-, three-, four-day supply but generally, we’re better than we were a couple weeks ago. The problem is that assumes the current number of COVID patients. If you fill up a hospital with 50 or 60 more like they do in New York City, the so-called ‘burn rate’ for every patient goes up a lot,” Kirby said on April 13.
He hopes the mobilization of manufacturers across the state will also contribute to a state stockpile for future emergencies.
“The national stockpile has been largely distributed, at least to the best of my understanding. South Carolina did get our share, that’s 1% based on population, but the volume of personal protective equipment is just so great, it quickly outstripped the national stockpile,” he said.
Chuck Spangler, CEO and president of the S.C. Manufacturing Extension Partnership, said he was awake until midnight after the announcement of the portal, responding to S.C. manufacturers who want to sell their critical needs goods through the portal.
“It’s been a thrill to see all of these companies step up, rise to the challenge and meet the critical needs in our state,” Spangler said.
By Tuesday morning, Spangler said about 80 companies had joined the portal to sell critical needs goods after careful vetting from portal organizers to bar price-gougers. Several offered donations.
“Last week, we saw an incredible response,” he said.
About 15 health care providers had already begun scouting out the portal for PPE and other equipment along with several manufacturers.
As many of the state’s manufacturers return to normal operations — Spangler thinks by May 4 — he hopes South Carolina will support each other by buying and selling PPE through the portal and is encouraging manufacturers to consider using other three-layer mask alternatives to preserve the stores of N95 masks for health care workers and food providers.
Courtesy: GSA Business Report
Elected Officials, State Epidemiologist Speak on South Carolina’s Path Forward from Pandemic July 16 in Free Public ForumSCBIO to host top leaders in free webinar July 16 at 10AM see more
Three of South Carolina’s leading elected officials will be joined by State Epidemiologist Dr. Linda Bell July 16 at 10 a.m. for a free webinar discussion about South Carolina’s path forward as the Palmetto State and America seek to weather the storm of COVID-19. Their comments will focus on avenues to help South Carolina escape the grip of the pandemic and rebound from its health, social and economic impact.
Entitled “Voices of Leadership: Charting South Carolina’s Path Forward", the program will feature South Carolina Lieutenant Governor Pamela Evette; state Representative Murrell Smith, the chair of the House Ways & Means Committee; state Senator Thomas Alexander, chair of the Labor, Commerce & Industry Committee; and Dr. Linda Bell, State Epidemiologist of South Carolina. The group discussion will be moderated by Sam Konduros, CEO of SCBIO, the state’s life sciences economic development organization.
The group will discuss such topics as:
- How South Carolina is currently faring in relation to COVID, highlighted progress to date and key data that will shape future direction of response to the pandemic in our state – and how DHEC is preparing accordingly
- From an economic and budget standpoint, what is the outlook for the state’s economy, and what projections and impacts should South Carolinians be aware of and prepared for
- While challenging in many respects, COVID-19 presents economic development opportunities for growth and expansion of life sciences across South Carolina as we recover from COVID. How can South Carolina maximize those opportunities?
- How accelerateSC’s initiatives to provide direction and leadership in reopening the state are faring, and how understanding of national and global insights is helping to refine strategies going forward
Participation in the webinar is free to all interested parties. Those wishing to participate can register while space remains at https://www.scbio.org/events/scbio-webinar-state-leaders-chart-scs-pathway-forward.
The 60-minute program will provide attendees with new insights on the pandemic’s impact in South Carolina to date, implications for returning to normalcy in the coming months, and strategies to secure and enhance the state’s future. The panelists will candidly address the path forward as South Carolina seeks a return to normalcy while still navigating a virus with no clear endpoint.
“Our goal is to bring the diverse viewpoints of these top officials in our state’s government and health arenas to speak to industry, education and the life sciences community. This forum will assess where we are, and how we can make a difference for our state to reduce COVID-19’s impact in the weeks to come,” said SCBIO CEO Sam Konduros.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 600 firms directly involved and 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
Okra Medical Receives a U.S. Patent for SafeMedWaste; Product destroys addictive substances like opioidsOKRA Medical product completely destroys highly addictive substances like opioids see more
Okra Medical is pleased to announce The US Patent and Trademark Office issued a Patent for Okra’s SafeMedWaste product suite which provides a safe, environmentally friendly, and cost-effective solution to ending the lifecycle of highly-addictive controlled substances, including opioids.
“With our patent in hand, we are beyond excited to get SafeMedWaste out onto the market and offer this exciting new alternative to destroying dangerous drugs such as opioids,” said Justin Stas, Chief Technology Officer, Okra Medical.
Currently many large manufacturers of prescription drugs incinerate their waste which is a costly solution to meet the regulatory requirement for destruction. Citizens, who have leftover prescription drugs often have to wait months for special “take-back” programs to safely discard the controlled substances. Now, Okra Medical’s SafeMedWaste provides a disposal product with verified results from a DEA-licensed laboratory proving its effectiveness for regulatory destruction of more than 30 controlled substances.
SafeMedWaste is the only drug disposal product verified to completely denature a wide variety of controlled substances using high performance liquid chromatography, mass spectroscopy(HPLC-MS). HPLC-MS is the only data that the DEA considers reliable and resolute enough to meet their definition of non retrievable based on what we know currently.
“Receiving this patent has taken more than a year of hard work, but it’s worth every minute knowing SafeMedWaste will help people destroy highly addictive drugs and potentially keep them out of the hands of people who might misuse them,” said Okra Medical’s CEO Marshall Hartmann.
According to statistics from a National Survey on Drug Use and Health, 11.4 million Americans misused illegal prescription opioids in 2017. SafeMedWaste provides a critical solution through its breakthrough formula that completely destroys highly addictive controlled substances often used in hospitals, hospice, pharmacies and veterinary care clinics. Destroying unused and unwanted prescription drugs helps eliminate the threat of diversion and misuse.
Patents are only granted for new, useful and non-obvious inventions. Okra Medical also filed a Patent Cooperation Treaty (PCT) application to protect SafeMedWaste intellectual property internationally.
About Okra Medical Inc.
Okra Medical, Inc., headquartered in Johns Island, South Carolina, specializes in product development, manufacturing and strategic sourcing of controlled pharmaceutical substance disposal solutions. Founded in 2018, the Company’s mission is to improve public health. Its best-in-class suite of SafeMedWaste products use single formulas that are fully compliant with DEA regulations requiring non-retrievable destruction of controlled substances. Okra Medical is a strategic sourcing partner to hospitals, hospice facilities, law enforcement agencies, pharmaceutical manufacturers, and veterinary care clinics. Visit www.okramedical.com
$30 million bio-ag investment to create 107 new jobs see more
Yield Scientific, a subsidiary of GEM Opportunity Zone Fund, today announced plans to establish operations in Hampton County. The company’s more than $30 million investment is projected to create 107 new jobs.
Founded in 2017, Yield Scientific is a hemp growing and processing operation that specializes in clinical-grade product development for the health care industry. Through its brand, Victis CBD, the company offers CBD products developed with high quality standards and advanced science.
Located at Southern Carolina Industrial Campus in Early Branch, Yield Scientific’s new facility will enhance the company’s product development and manufacturing capabilities.
The new operations are expected to be online by the first quarter of 2021. Individuals interested in joining the Yield Scientific team should visit https://www.yieldsci.com.
The Coordinating Council for Economic Development has approved job development credits related to this project. Hampton County was also awarded a $50,000 Rural Infrastructure Fund grant to assist with costs related to this project.
“We are very pleased to join the Hampton County community of corporate citizens. Through Yield Scientific and the Victis CBD brand, we will invest over $30 million and create 107 jobs in a pharmaceutical-grade growing and processing complex within the Southern Carolina Industrial Campus in Early Branch. Our project would not have happened without the support and work of the SouthernCarolina Alliance team, the Department of Commerce, the Department of Agriculture and Hampton County.” -GEM Opportunity Zone Fund CEO Zeb Portanova
“We’re thrilled that Yield Scientific has chosen to invest in South Carolina’s growing hemp industry and her people, creating more than 100 good jobs in one of our state’s rural gems.” –Gov. Henry McMaster
“Our approach to creating a business-friendly environment for all types of companies continues to pay off, and Yield Scientific’s investment in Hampton County is a testament to that. I look forward to watching the company thrive here for many years to come.” -Secretary of Commerce Bobby Hitt
“Yield Scientific is a wonderful addition to South Carolina’s burgeoning hemp industry. Their greenhouse operations and processing capacity will create skilled agriculture jobs – and in an Opportunity Zone, no less.” -Commissioner of Agriculture Hugh Weathers
“We are both proud and grateful that this innovative company has chosen Hampton County as the home for their new operation. Each of the 107 jobs they are creating will affect the future of a family in our region, which is why economic development is so important to the quality of life in a community.” -Hampton County Council Chairman Clay Bishop
“Hampton County welcomes Yield Scientific to the Southern Carolina Industrial Campus. We are thrilled to have a state-of-the-art agribusiness producing food and nutrition products in Early Branch.” -Hampton County Economic Development Commission Chairman Bill Hager
“The visionary leadership of Yield Scientific and the GEM Opportunity Zone Fund will bring job opportunities and investment to our region while supplying the global food network with agricultural products grown through advanced scientific protocol. We believe this kind of innovation is more important than ever to our regional and state economies in the coming years.” -SouthernCarolina Alliance Chairman Marty Sauls
Online portals like South Carolina's are connecting the needy with vital PPE see more
Online portals are connecting hospitals short on personal protective equipment with local businesses making the items.
Businesses across the country have switched gears away from the production of their usual wares to manufacturing personal protective equipment in high demand during the coronavirus pandemic.
But with equipment shortages and so many new vendors entering the marketplace, doctors’ offices, hospitals, and other businesses looking for the supplies may not know where to turn. So, states have launched online portals to help match would-be customers with manufacturers that can meet their needs.
In Pennsylvania, the Department of Community and Economic Development launched a business-to-business directory last week that provides contact information for local manufacturers of a variety of N95 respirator masks and cloth masks, as well as thermometers. To compile the directory, the state put out a call for manufacturers or suppliers of in-demand PPE through two web portals.
“Through this process, we recognized that we can help foster direct business connections to provide Pennsylvanians access to critical supplies expeditiously without a middleman,” said Dennis Davin, secretary of the economic development agency.
The first portal launched in March and sought information from manufacturers and suppliers about equipment that the state could purchase for medical providers, emergency responders, and health care professionals. Through the second portal, the Pennsylvania Manufacturing Call to Action Portal, companies could report their own supply chain capabilities, needs, or workforce gaps.
The nation’s economy has slowed down dramatically as states ordered residents to stay at home and non-essential businesses to close to help stop the spread of the virus. To both keep workers employed and to meet the staggering demands for masks and other equipment needed by health care providers, businesses across the country have begun repurposing their equipment and supplies to manufacture personal protective equipment.
Distilleries have swapped whiskey for hand sanitizer. A company that makes wallets and outdoor gear from recycled sailcloth is now manufacturing face shields. And a 3-D printing business is now churning out thousands of nasal test swabs.
But it’s made for a confusing marketplace, said Chuck Spangler, director of the South Carolina Manufacturing Extension Partnership, one of several partners helping to run an online PPE supply portal in the state.
The launch of the South Carolina Covid-19 Emergency Supply Collaborative has made it much easier to track the current needs of hospitals and other medical providers and to funnel business back into local economies, Spangler said.
“We needed to know the demand from the health care providers so we could be more effective,” he said.
The collaborative, which has partnered with the state’s Department of Commerce, the South Carolina Hospital Association, and SCBIO, the voice of the South Carolina Life Sciences Industry, regularly updates the list of critical needs items on its website. When medical providers reach out to the collaborative to discuss their supply needs, the collaborative responds with a list of manufacturers or suppliers they have vetted to ensure they are properly licensed.
About 70% of the 172 of the manufacturers or suppliers currently working with the collaborative are located in South Carolina, which means the effort has been able to channel business back into the state’s economy while also meeting its healthcare needs, Spangler said.
As a result, some businesses have been able to limit the number of employees laid off during the economic crisis while others are even growing. Spangler said. One 3-D printing company that went from producing 30,000 face shields a day to 200,000 and had to staff up to accommodate the demand, he said.
He hopes the investment in local sourcing will help the state’s economy bounce back once the pandemic is over.
Challenges the collaborative expects to encounter in the near future include sourcing supplies for a broader array of businesses that will be allowed to reopen in the coming weeks as the state’s stay-at-home order is relaxed. Another hurdle will be securing equipment for small businesses that may have orders sidelined by their regular suppliers struggling to fill bulk orders.
“Their suppliers are pushing them out and saying, ‘Sorry you can’t get product until the end of May,’” Spangler said.
Acquiring an adequate amount of personal protective equipment will be vital to restarting local economies across the country.
In Missouri, Gov. Mike Parson announced an online PPE portal this week, noting that a key pillar of his plan to reopen the state is expanding the state’s reserves of PPE by opening public and private supply chains. The state reports getting interest in the portal from more than 200 companies.
“Manufacturers across the state have answered the call to help protect our health care workers, and we are committed to doing all we can to get this equipment into the hands of those that need it,” Parson said.
SCRA added three advisory groups for biomedical sciences, cybersecurity and industry see more
Summerville, S.C.—South Carolina Research Authority (SCRA) announces the formation of three Business and Science Advisory Boards (BSABs). The purpose of the BSABs is to advise SCRA’s Board of Trustees when requested by it. The boards include representatives from South Carolina research universities, the venture capital/angel investment community, South Carolina Department of Commerce, and industry leaders in the following areas:
Each board provides key business and technical expertise, acts as an independent/ unbiased sounding board for input on SCRA’s program implementation and performance and provides guidance to SCRA regarding funding opportunities. One upcoming funding opportunity on which the BSABs will advise is the SCRA-Academia Collaboration Team (SACT) Collaborative Research Grants. These grants will be available for multi-institutional, collaborative research teams that seek to advance commercially relevant research and address key industry challenges to foster technology-enabled growth of the state’s innovation economy. The solicitation will be released in June.
“SCRA serves as a bridge between industry and academia. It is imperative that the applied research SCRA funds benefits not only its academic stakeholders, but also South Carolina’s industrial base. The development of the BSABs ensures that the new SACT program achieves those objectives for both stakeholder groups,” said Christine Dixon Thiesing, SCRA Director of Academic Innovations.
The SCRA fuels South Carolina’s innovation economy by accelerating technology-enabled growth in academia, entrepreneurship and industry. SCRA works with public and private sectors, including industry, to identify market trends and validate the commercial relevance of academic research that SCRA funds. SCRA’s programs and operations had an almost $700 million impact on the state’s economy during the last fiscal year.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, SCRA fuels South Carolina’s Innovation Economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry.
SCBIO's latest newsletter is full of the news you need see more
This week's SCBIO newsletter is chock full of helpful news and resources to assist you in navigating the COVID-19 pandemic. Learn about the just-launched Emergency Supply Portal... a job board for hiring displaced workers... mini-profiles on how SC companies are stepping up... the latest news, big savings and much more. Click here to read in full right now!
Gain inspiration from today Monday Moment from SCBIO see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 2 minutes or less. This week, enjoy an uplifting reminder from Womble Bond Dickinson's Stephanie Few that we're all in this together, plus helpful webinars, news on how SC is stepping up, and more good news to kickstart your day...
South Carolina Launches COVID-19 Emergency Supply Portal to Connect Providers with Organizations in NeedSouth Carolina launches portal to connect critical supplies with those who need them see more
SCMEP, South Carolina Hospital Association, SC Department of Commerce and SCBIO combine
to source critical medical supplies and get them to parties in need quickly
South Carolina – April 13, 2020 – A collaboration between SCMEP, the SC Hospital Association, the SC Department of Commerce and SCBIO has resulted in the expedited launch of a new online South Carolina Emergency Supply Collaborative web portal.
Located at www.SCCOVID19.org, the portal connects parties in need of essential supplies and equipment with those that can provide it in quickly and efficiently. It allows industry and community partners with the ability to quickly produce, source, test, certify or contribute critical medical supplies (such as face shields, gowns, ventilators and masks) to directly connect with the healthcare providers, first responders and members of industry in search of those essential supply needs in one easy step.
Manufacturers able to expand or pivot their production lines, suppliers and distributors with access to ready-made supplies, organizations able to donate supplies or personal protective equipment (PPE) can identify the supplies and equipment they can offer in the site’s central repository. Once quickly reviewed and vetted by a team from the collaborative, organizations in need of the materials will be digitally connected through the portal to secure their desired goods from providers directly.
The need for the portal was identified after members of the collaborative began individually fielding hundreds of calls from organizations in need of such supplies, said Chuck Spangler, President of the South Carolina Manufacturing Extension Partnership (SCMEP).
“Each of our respective organizations has strong and indelible positions as sources of information, connection and aid to our respective constituencies, so it was logical for those parties – whether hospitals or manufacturers, existing industry or life sciences organizations – to turn to us in time of need,” said Mr. Spangler. “After sharing among ourselves the flood of requests we were individually receiving and trying to manage, we determined that a combined approach would offer greatest value and efficiency for our state and its citizens, and the creation of the South Carolina COVID-19 Emergency Supply portal was quickly underway.”
The site identifies critical need items as evidenced by industry, healthcare, first responder and governmental audiences across the state, and allows organizations to quickly enter the type of goods they can provide or manufacture, quantities and production capacity, and supply chain needs or requirements. Once entered and vetted by the SCMEP team, inquiring parties seeking the goods will be connected to the providers through the portal. Organizations then conduct transactions and arrange and plan logistics directly.
“This is a joint effort to recruit community partners with ability to quickly source or provide needed medical supplies to support South Carolina’s COVID-19 response,” said Thornton Kirby, President and CEO of the SC Hospital Association. “South Carolina’s COVID-19 Emergency Supply website will save valuable time and effort in connecting those in need of goods with those who have them… at a time where every minute counts in saving lives and defeating this formidable virus.”
The COVID-19 Emergency Supply website will be updated constantly with new information and opportunities to support South Carolina emergency response efforts. It also links directly to individual websites of the four Collaborative partners, which each provide a host of resources, news, connections and relevant information for businesses and individuals.
“We are all in this together, and I am proud of the South Carolina business community’s continued response to serve our state during this unprecedented time,” said S.C. Secretary of Commerce Bobby Hitt. “The COVID-19 Emergency Supply Collaborative’s ability to connect manufacturers, suppliers and other organizations with the front-line medical personnel who need these critical items will serve as a valuable resource.”
Organizations and individuals can go online 24/7 to identify critical need items or to note what products they can provide or may need, said Sam Konduros, CEO of SCBIO. “We encourage every member of industry, if you have a product that is needed and which you can provide, produce, test, certify or donate, let us know that right now by completing the simple form on the site. And for organizations in need of such items, let us know that right away so that we can get connect you with parties who can help right now.”
Visit the new site at https://sccovid19.org/
Precision Genetics receives SCRA grant see more
SCRA announces a $250,000 SC Launch, Inc. investment in Precision Genetics. The life sciences company, located in Greenville, was recently accepted into SCRA’s entrepreneurial program, SC Launch.
Precision Genetics validated the Emergency Use Authorization (EUA) via the Food and Drug Administration (FDA) to process COVID-19 test kits. Precision Genetics is now available to support state and local healthcare systems in need of public health surveillance, and has priority access to test reagents from commercial reagent manufacturers, which have received EUA from the FDA.
Precision Genetics provides the test kits for healthcare facilities and providers looking to test patients using real-time RT-polymerase chain reaction (RT-PCR) detection of the SARS-CoV-2 virus (the virus that causes COVID-19) in respiratory specimens. The test uses RT-PCR to detect the virus in upper and lower respiratory specimens.
Currently, results will be available within 24 hours (one business day) from time of receipt of the sample in the laboratory, with plans to boost testing capacity in the coming week. Precision Genetics’ healthcare technology laboratory has the capability to direct-connect to other laboratories, healthcare systems, and practitioners’ offices to deliver test information within seconds of the results being reported. The laboratory uses a cloud-based information system, Ovation.io, to help expedite the test orders, specimen tracking, and results to support faster response times to the COVID-19 pandemic.
In addition to COVID-19 testing, Precision Genetics uses an advanced scientific approach to treating employees and patients, using healthcare data to determine the risks associated with medications and complex drug regimens. By combining genetic markers, molecular data, and clinical evidence into a comprehensive and actionable solution, they allow providers to immediately develop individualized treatment and prevention plans for their patients.
“Healthcare facilities throughout South Carolina were struggling to find COVID-19 test facilities that could provide both accurate and timely results”, said Steve Johnson, SCRA Investment Manager. “Some institutions were waiting eight days or more before receiving results. Other testing services were no longer even accepting any further samples. It was critical that an experienced South Carolina-based lab have the throughput capacity to handle the volume of COVID-19 testing that was predicted to be coming. Because of Precision Genetics’ existing track record of providing excellent advanced molecular testing and innovative solutions to healthcare institutions in the state, SCRA and SC Launch, Inc. are proud to provide this investment to Precision Genetics at a time when their capabilities are critically needed in our state.”
“This national and statewide pandemic has challenged us as business leaders to create immediate solutions on behalf of our patients and healthcare providers. The challenge in South Carolina is that we lack sufficient laboratory infrastructure to deploy testing solutions in rapid form in order to manage the immenent demand that our state requires. All labs face a similar obstacle of obtaining the necessary resources and supplies to accommodate our patient volumes. SCRA and SC Launch, Inc. stepped up and provided financial commitment and strategic support for us to expedite our efforts. We are desperately trying to serve our community in this time of need, and we are very grateful for the support from SCRA and SC Launch, Inc.” said Nate Wilbourne, CEO of Precision Genetics.
SCRA is a state-chartered organization that fuels job creation and grows South Carolina’s innovation economy. Through SCRA’s programs, early-stage companies are provided mentoring and grants and may be eligible for an investment from SCRA’s investment affiliate, SC Launch, Inc.
Monday Moment for 4-6-20 see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 2 minutes or less. This week, enjoy an uplifting reminder from Nephron's Lou Kennedy that we're all in this together, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.
Enjoy SCBIO's latest news and events! see more
SCBIO continues to provide assistance, connections and resources to help our state deal with the increasing COVID-19 threat.
Check out this latest newsletter to access information on up-to-date safety, infection control and health protocols recommended by experts...
Regular webinars dealing with timely topics...
Supply chain connections assisting those in need of medicines, testing kits, personal protective equipment and other goods with suppliers who can assist them...
Assistance in accessing regulatory bodies to get solutions to market quickly... and
Great stories of how South Carolina companies are stepping up to help in this time of critical need.
Nephron seeks to stem coronavirus concerns with expanded offerings see more
In response to the novel coronavirus pandemic, West Columbia-based Nephron Pharmaceuticals Corp. has asked the Food and Drug Administration for permission to add up to six filling lines to ramp up its production of sterile respiratory medication.
Nephron CEO Lou Kennedy said she spoke with the FDA on Tuesday morning and is “waiting to hear back.” Kennedy also said Nephron will begin making its own hand sanitizer as early as this week.
Nephron, which CEO Lou Kennedy said is one of two companies in the U.S. that produce 98% of the nebulizer solutions used in hospitals or sold in retail outlets, relocated to South Carolina from Florida in 2014.
“We didn’t move all the equipment right away,” moving an additional six filling lines to South Carolina in 2019, Kennedy said. She said she had been in discussion with the FDA for permission to bring those machines online. A meeting had been scheduled for March 22 before she made another request Tuesday.
West Columbia-based Nephron has asked for FDA approval to add up to six filling lines for its respiratory medication manufacturing. CEO Lou Kennedy also announced the company will begin making hand sanitizer this week. (Photo/File)
The eight filling lines currently being used in production of the inhalation solutions Nephron makes typically produce 80 to 85 million doses a month “on a regular basis” and are capable of making up to 110 million monthly doses, Kennedy said.
“As of yesterday, we had orders on the books for 87 million, so already a month’s worth,” Kennedy said. “For the last two weeks, those orders have been running about 48% higher than we would normally see. … We do have backstock that we’ve built up in inventory, (but) that won’t last forever.”
To maximize Nephron’s 24-hour, seven-day-a-week production schedule, Kennedy said the company has begun providing in-house child care. Children are provided food, and already stringent cleaning efforts have been “tripled,” Kennedy said. She said the same methods used to maintain sterile facility conditions, including the use of a fogging machine and wiping down surfaces with isopropyl alcohol and hydrogen peroxide, are being deployed in the day care.
“We’re really good at cleaning here, because we only make sterile drugs,” Kennedy said. “I’m very confident about making a clean environment for these children.”
During a conference call Tuesday, Kennedy also said Nephron has received FDA approval to begin making its own hand sanitizer and ordered supplies to do so on Monday.
“We will take care of the Nephron family first, and after we do that, we will look at should we go through churches, the Salvation Army, how can we help the community, and/or commercial production,” she said. “I’ve had at least six requests from various sales reps across the country. Hospitals are asking can we make that hand sanitizer for them.”
The plan is to produce 50-liter batches of a strong, FDA recipe without fragrances or other diluting agents, Kennedy said. She said she will gift what is left over from the first batch, after Nephron employees and their families have been served, to local charities.
Kennedy said as early as December, Nephron began taking stock of things such as the resin used to make vials of its liquid medication as well as its supply of active pharmaceutical ingredients. “We are fortunate that we have more than a year’s supply of that (API) on hand,” she said.
Nephron makes bronchodilators including albuterol used to treat respiratory illnesses such as bronchial asthma, pneumonia, emphysema and croup. It also manufactures Pocket Nebs, which are portable, battery-charged nebulizers.
Novel coronavirus can cause cough, shortness of breath and breathing difficulties. Severe infections can lead to complications including pneumonia, according to the World Health Organization.
Increased product demand during cold, cough and allergy season, as well as past experience with respiratory illnesses including SARS and H1N1, have made the company ever-vigilant, Kennedy said.
“We make sure to be very rock-solid in our preparation to accommodate the needs of America,” she said.
Kennedy said hiring and training has already begun in anticipation of FDA approval of the additional filling lines.
“We have the people to be able to ramp that up right now,” she said. “ … If we don’t get our hands wrapped around this quickly, meaning we squelch the spread, get control of the spread, it’s going to be a long, hard road. But it’s easily solved if the FDA allows me to ramp up the five or six other lines that I brought here from Florida.”
Company making up to 71,000 RNA extractions available to testing laboratories see more
GREENVILLE, S.C. – April 1, 2020 – KIYATEC, Inc., a clinical-stage leader in ex vivo 3D cell culture testing that supports cancer drug development and drug therapy decision-making, announced today that it is making high-throughput RNA extraction services available to clinical laboratories nationwide that are conducting COVID-19 testing. By creating additional capacity for RNA extraction, a critical component of the COVID-19 testing process, KIYATEC believes it will help testing laboratories normalize the processing and delivery of test results at a time of unprecedented testing demand and turnaround times.
Most coronavirus tests rely on RNA extraction as the first technical step; without it, the test cannot be performed. Nationwide shortages and backlogs in the reagents and kits most often used to perform these extractions have created bottlenecks and delays that have impacted COVID-19 testing volume and throughput, thereby prompting the U.S. Food and Drug Administration (FDA) to approve alternate testing processes under Emergency Use Authorization (EAU) status. With an already CLIA-certified and operational high complexity lab, KIYATEC is joining the fight against this pandemic by offering its RNA extraction services to COVID-19 testing laboratories.
While KIYATEC’s core business in oncology continues to occupy much of its laboratory testing capacity, the company has elected to make up to 71,000 RNA extractions available over the next two months, effective immediately, on a fee-for-service basis to COVID-19 testing laboratories nationwide. At a time when COVID-19 testing volume and turnaround times are surging, KIYATEC’s 24-hour turnaround time per RNA extraction could provide a cost-effective efficiency boost to laboratories performing these tests. Making RNA extraction services available to COVID-19 testing laboratories is consistent with KIYATEC’s core goals of improving patient care and outcomes.
“Although KIYATEC traditionally serves the oncology community exclusively, we quickly determined that our existing technical infrastructure and capabilities in RNA extraction were ideally aligned to address this critical pressure point in the COVID-19 test process,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Following discussions with public health thought leaders and COVID-19 testing laboratories, we realized that offering RNA extraction services could provide immediate help to these laboratories in overcoming possible supply chain challenges and optimizing their volume and turnaround time potential.”
About KIYATEC, Inc.
KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.
Lillia Holmes, Chief Operating Officer, 864-502-2013
Power of Collaboration: South Carolina’s Humimic Medical Arming Healthcare Workers for the COVID-19 WarHumimic Medical is stepping up for South Carolina see more
As a growing number of healthcare workers join the front lines to battle the global COVID-19 pandemic, or Coronavirus, here in America, there is critical need for basic personal protective equipment (PPE) to protect them – PPE which is now in short supply in many areas across America.
South Carolina entrepreneurs and industry leaders are stepping up in unprecedented ways to protect these first responders and to defeat the global pandemic.
Joel Edwards, CEO of Greenville’s Humimic Medical, decided his organization could do something about it – even though his company did not manufacture essential equipment like face masks, face shields, swabs, or gloves. Edwards estimated that if his team could re-purpose their own product designs and manufacturing capacity, they could deliver a quality version of these critical supplies at relatively low price-points – mirroring the approach for their existing synthetic gel and medical trainer products. With help from Deborah Herbert, President of Multiplastics in Mt. Pleasant, the company had plans and suppliers in place in less than 48 hours to deliver 80,000+ face shields over the next few weeks.
“As we sat around the table during a team meeting last week, we found ourselves asking each other how we can help,” said Edwards. “We knew we had to make something happen fast to make a difference, because healthcare workers don’t need something 3-4 weeks from now, they need it now.”
The Humimic team picked up drafting pencils and phones to devise a plan they could execute quickly, and had designs and suppliers lined up within one day and working prototypes ready to scale up 24 hours later.
The speed and agility demonstrated by Humimic Medical is not only a testament to the company’s ability to pivot and respond to market needs, but also showcases the rich, collaborative ecosystem that has emerged within South Carolina. Edwards was able to leverage relationships with physicians in a nearby health system to validate the design, tap vendor and supplier relationships through South Carolina’s Department of Commerce, and gain key insights and connections through groups like SCBIO, the South Carolina Biotechnology Industry Organization, which serves as the life science community’s catalyst for building, advancing and growing the industry.
Added SCBIO President and CEO Sam Konduros, whose team was able to rapidly connect Humimic with key contacts to deliver the new face shields where they are needed most, “We continue to live our mission of being the life sciences industry convener, and that’s more important than ever right now.”
“SCBIO has been a tremendous asset in this process” said Edwards. “Their team has walked right alongside of ours to ensure we maximize this opportunity to serve our front-line healthcare workers.”
He also hinted that Humimic Medical isn’t stopping with face shields either, as they work to develop other key supplies in short supply including a novel nasal swab and innovative re-usable face masks.
“The need is great, and we’re committed to making a difference during this time of need,” he added.
About Humimic Medical:
Humimic Medical is a rapidly growing medical trainer and synthetic gel manufacturing company based in Greenville, SC. The company is driven by innovative product design, world-class customer service, and fueled by robust collaborative partnerships with universities and healthcare providers. Humimic Medical utilizes its proprietary synthetic gel blend to more closely represent human tissue elasticity and maintain recyclable/reusable qualities that no other product line currently offers delivered at a significantly lower price point than any existing products.