Zverse adding to capabilities with new product offerings see more
Columbia-based digital manufacturing solutions company ZVerse Inc. has launched new technology that creates 3D computer-aided design files from 2D technical drawings, cutting some project times by as much as half.
The automation-assisted conversion generates a rapid 3D conversion project quote, then creates 3D manufacturing files that can be stored in a digital library, allowing field and repair technicians to quickly access the files and manufacture parts from anywhere, according to a news release from ZVerse.
“ZVerse has been doing this work for years, converting 2D files to 3D through our on-demand design services,” company president David Craig said in the release. “We know the areas where you can drive automation and drive the biggest impact in workflow. We have also learned that the greatest time spent in the conversion process can be automated and we now have automated those steps. We are committed to driving even more types of automation in and around this critical business need.”
Project times can be reduced by an average of 35% to 50% with the elimination of the need to re-draw part geometries at current manufacturing software standards, the company said.
The advancement will address the lack of 3D digital files that is an obstacle to digital manufacturing and on-demand maintenance, repair and overhaul part production at scale, according to the release. Manufacturing engineers and industrial designer can more quickly convert legacy files, resulting in time and cost savings while improving geometric accuracy.
The service will also reduce equipment downtime, reduce production costs and allow ZVerse customers to carry less inventory, the company said.
Founded in 2013, ZVerse shot to national prominence last year with the development of its ZShield Flex face shield, which was named an Innovation by Design Awards winner by business magazine Fast Company.
Columbia College partners for better health see more
Eau Claire Cooperative Health Center (dba Cooperative Health) and Columbia College are pleased to announce a partnership to bring health care services to its campus and the local community starting Monday, March 22.
Columbia Community Family Practice will provide primary and preventative services for adult and pediatric patients, in addition to behavioral health counseling. The practice will be housed inside a 2,000 square foot-building on the Columbia College campus, located at 4808 Colonial Drive.
“We are excited to be partnering with Cooperative Health to provide much needed services to our own campus and also to the broader neighborhood community,” said Dr. Tom Bogart, president of Columbia College. “Cooperative Health is an important health provider in the Midlands. This partnership is an example of how we are able to collaborate and respond to key issues in our community.”
Columbia Community Family Practice will promote optimal wellness in campus and community members by removing socioeconomic barriers to care; enabling individuals to make informed health decisions; and empowering individuals to be self-directed consumers of their health care services.
“Cooperative Health is ecstatic to partner with Columbia College to bring a comprehensive health care facility to its campus. The presence of Columbia Community Medical Practice will improve the health of the student body and others within the 29203 community. We would like to thank the dynamic leadership of Columbia College for making this possible and welcoming us,” said Peatra Cruz, Chief Organizational Development and Communications Officer.
La’Kia Singleton, MSN, FNP-BC, will serve as the lead provider at the Columbia Community Family Practice. She brings more than a decade of experience as a family nurse practitioner with a specialty of treating acute and chronic health conditions for all ages.
An opening for Columbia Community Family Practice was held at the site on Friday, March 19. Due to the COVID-19 pandemic, the event was invitation only but was live streamed on Cooperative Health and Columbia College Facebook channels. Columbia Community Family Practice will operate Monday through Friday from 8:30 a.m. to 5:00 p.m. Call (803) 888-1106 to schedule an appointment.
About Eau Claire Cooperative Health Center (dba Cooperative Health)
Cooperative Health is a Federally Qualified Health Center (FQHC) and a Federal Tort Claims Act (FTCA) deemed facility. It operates as an independent non-profit organization providing primary care and preventative services with the aim of improving the health of patients on a community level. Cooperative Health offers comprehensive services including: family medicine, internal medicine, pediatrics, women’s health, behavioral medicine, dental, pharmacy, orthopedics and podiatry. In 2019, Cooperative Health provided health care services to more than 61,000 patients throughout the Midlands of South Carolina. It has a network of sites located throughout medically underserved areas in Richland, Lexington, Fairfield, and Newberry counties. Cooperative Health is recognized by the National Committee for Quality Assurance (NCQA) as a Patient Centered Medical Home.
About Columbia College
Columbia College was founded in 1854 as Columbia Female College by the Methodist Conference of South Carolina. Columbia College continues to serve as an institution for higher education with approximately 1,200 male and female students in both undergraduate and graduate courses.
IMCS growing into new space, adding positions see more
An Irmo-based biotechnology company is investing $4.1 million to expand its Richland County operations in a move expected to create 31 jobs during the next five years.
Integrated Micro-Chromatography Systems Inc. creates, manufactures and distributes products and services for clients including clinical and forensic toxicology labs, academic research facilities, federal government agencies and health science companies. In January, the National Institutes of Health awarded the company a $900,000 Small Business Innovation Research Fast-Track grant.
“Over the past several years, IMCS has experienced considerable success as a part of the Richland County business community,” Andrew Lee, IMCS CEO, said in a news release. “The tax incentives provided by the county will allow us to continue investing in people, capital equipment and facilities to expand our company and increase economic development in the county.”
Richland County Council approved a special source revenue credit to reduce property taxes for IMCS by 35% over a 10-year period.
“County Council is always eager to support growing businesses in Richland County, and it is especially exciting to watch a company like IMCS get its start here and achieve so much,” Paul Livingston, county council chair, said. “The investment and new jobs IMCS is bringing to our community will benefit our residents and are evidence of the type of success businesses can achieve here.”
IMCS’ enzymes are used in drug-testing labs, and drug discovery labs use the company’s micro separations products to discover antibodies that can be used to fight diseases such as COVID-19. IMCS is using the federal grant to scale up production of new enzymes that will be used to make therapeutic drugs for treating neurodegenerative diseases such as Parkinson’s and Alzheimer’s.
The grant is funding research into the production of affordable gangliosides, biomolecules that contain sugars and a type of lipid called ceramides and play critical roles in various biological processes.
In addition to its headquarters in Richland County, IMCS bought a second nearby facility in 2019 and anticipates purchasing a larger building in the county in the future, according to the release from Richland County. IMCS is combining the existing facilities to ramp up production and delivery of its products to pharmaceutical companies worldwide.
“We were a USC IdeaLabs incubator company and have continued to grow in the county over the past seven years,” Lee said. “As we look to expand our operation to a third facility, it is only natural that we would want to do so here.”
The new investment and jobs will be split between IMCS’ Irmo headquarters and the new facility.
Founded in 2013 by three Ph.D. scientists from the University of South Carolina, IMCS now has 40 full-time employees, with 600 clients in every U.S. state and in 15 countries.
DPX earns SBIR grant see more
DPX Technologies, a manufacturer of laboratory consumables for sample preparation, receives over $250,000 from the National Science Foundation (NSF) for a Small Business Innovation Research (SBIR) Phase I project. The project involves rapid purification of RNA and the development of fast detection for COVID-19.
RNA extraction is a key pre-analytical sample preparation step for viral RNA detection. Viral RNA detection is the current worldwide strategy used for early detection of the novel coronavirus SARS-Cov-2. The magnitude of the COVID-19 pandemic calls for unprecedented high throughput testing.
DPX Technologies has been developing sample preparation products for high throughput, automated methods for over a decade. Their patented and proprietary pipette tip technology harnesses the power of automated liquid handlers to provide solutions for a variety of applications. DPX was able to leverage the help and expertise of Tyler Tatum at 3Phase SC. “Tyler helped with navigating through all of the paperwork and rules. He was great to work with and extremely knowledgeable,” said William Brewer, CEO of DPX Technologies and principal investigator on the SBIR Award.
The South Carolina Department of Commerce Office of Innovation launched 3Phase in 2018 as a resource aimed at assisting research-based companies in South Carolina successfully acquire Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards. 3Phase provides training and workshops throughout the state on the federal SBIR and STTR programs, while managing the application process for a portfolio of companies, both at no cost to participants. The SBIR program funds early-stage research and development and is designed to provide equity-free funding. These investments stimulate technological innovation in the private sector, strengthening the role of small business in meeting federal research and development needs.*
* Excerpt regarding information on 3Phase program from South Carolina Department of Commerce website and https://www.3phasesc.com/
About DPX Technologies
DPX is committed to providing innovative sample purification solutions. We collaborate with our customers to provide the high-quality products they need for complex chemical and biological analysis.
Life sciences company establishes diversity internship program see more
The ISPE Foundation and Nephron Pharmaceuticals Corporation announced a partnership on the ISPE Foundation Diversity Internship Program's newest cycle to provide world-class opportunities to groups that are typically underrepresented in the pharmaceutical industry.
Established December 2020, the pilot ISPE Foundation Diversity Internship Program received a strong response from applicants. This series with Nephron will be a 12-week experience that offers graduate and undergraduate students in their junior or senior year the opportunity to spend the summer working on priority projects for one of the fastest-growing pharmaceutical companies in the country.
“I am delighted and honored to announce the partnership of Nephron Pharmaceuticals with the ISPE Foundation on its Diversity Internship Program,” said Antonio Moreira, PhD, ISPE Foundation Board Chair, Vice Provost, Academic Affairs, University of Maryland Baltimore County. “Over the coming years, a diverse pool of very talented students will be engaged in a variety of technologically stimulating projects under the guidance and mentorship of Nephron Pharmaceuticals scientists and engineers. These life changing experiences will inspire the interns to continue pursuing the many career opportunities that the pharmaceutical industry offers to these future leaders.”
“We pride ourselves on two things: first, we do everything we can to make sure that everyone has a chance to achieve their dreams, and second, we utilize interns and apprentices in everything we do – they are playing key roles in our expansion and growth,” said Lou Kennedy, CEO, Nephron. “This is why I am so excited to partner with the ISPE Foundation to rollout these new internship opportunities. They represent a win-win – for participants and for our company. We are proud to invest in talented young people, and we are excited they want to invest in us. We cannot wait to get started.”
There are currently multiple internship opportunities through the ISPE Foundation-Nephron partnership, including in the following departments:
- Analytical Services and Formulation
- Molecular Biology
The individuals participating in these internships will play key roles in Nephron’s ongoing projects. They will work directly with the entire Nephron team. And they will make a difference for patients across America.
The deadline to submit is 6 May 2021. To learn more, please visit ISPEFoundation.org/Diversity-Internship-Program.
About ISPE and ISPE Foundation
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its 18,000+ Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. Founded in 2017 as the philanthropic arm of ISPE, the ISPE Foundation supports education, training, and research for the advancement of innovative technologies and provides solutions to global challenges in the development, manufacture, and supply of quality pharmaceutical products for the benefit of patients around the world. To aide in this endeavor, the Foundation focuses on initiatives related to increasing the technical knowledge of the incoming workforce, fostering diversity within the industry, and supporting efforts to bring quality pharmaceutical manufacturing to new markets. Visit ISPEFoundation.org for more information.
About Nephron Pharmaceuticals Corporation
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs.
Inquiries related to the program may be directed to Foundation@ISPE.org.
USC adds accolades for its medical school see more
The University of South Carolina School of Medicine Columbia is the top medical program in the country for graduates who are practicing in areas where there is a shortage of health care professionals, according to the latest U.S. News & World Report’s Best Graduate School rankings.
The medical school’s distinction is part of the U.S. News rankings released March 30; the rankings show that UofSC is now home to more than 60 nationally ranked programs.
Among those is the International MBA program in the Darla Moore School of Business, which retained its No. 1 ranking for the eighth consecutive year.
“From meeting the health care needs of South Carolina’s underserved communities to preparing graduates to excel in careers in all corners of the world, these rankings demonstrate the work our faculty, staff and students do each day to improve the lives of people across the state, nation and world,” says William Tate, the university’s provost and executive vice president of academic affairs.
The School of Medicine’s No. 1 ranking fulfills the university’s mission by providing doctors for underserved areas, sometimes referred to as “medical deserts.”
The Columbia med school also ranks No. 45 for the number of doctors practicing in primary care specialties and No. 54 for graduates practicing direct patient care in rural areas. The School of Medicine is ranked No. 76 nationally in primary care, improving 14 spots from last year’s U.S. News rankings.
“We are proud to be producing graduates who are committed to providing exceptional patient care to underserved communities,” says Dr. Les Hall, dean of the UofSC School of Medicine Columbia. “Our school was established to create a pipeline of quality health care professionals for South Carolina. These rankings are a clear illustration that we are achieving that mission and more.”
The Moore School continued its reign as the highest ranked international business master’s program in the country. The International MBA has been ranked in the top three for 32 straight years.
The university’s ranked graduate and professional programs include diverse areas of study in the sciences, humanities, technology, engineering, health sciences, law and business.
Other highlights from the new rankings include:
- No. 7 for school library media.
- No. 9 for services for children and youth.
- No. 17 for library and information studies.
- No. 23 for criminology program.
- No. 25 for part-time MBA.
- No. 25 for nuclear engineering.
- No. 25 for speech language pathology.
Ahead of Spring Break, Makers of ZShield Product Line Offer Easy Way to Stay Safe, Avoid Coronavirus see more
Digital manufacturing company ZVerse, Inc., makers of the award winning ZShield line of face shield and face mask products, has launched a public service campaign aimed at promoting the best way to stay protected against the COVID-19 virus.
As Spring Break approaches and coronavirus cases remain high across the U.S., ZVerse is recommending a "Good-Better-Best" model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
ZVerse is recommending a “Good-Better-Best” model for wearing Personal Protective Equipment (PPE) based on public health guidelines and customer feedback.
The simple model recommends wearing a face mask as a minimum, or good level of protection, followed by a face mask and a face shield combined for better protection. The best protection comes with wearing a filtered face mask combined with a face shield, according to the ZVerse model.
"Experts are warning of a new pandemic wave if people let down their guard during the upcoming Easter and Spring Break holidays and fail to protect themselves and their loved ones," said ZVerse Founder & CEO John Carrington. "At ZVerse, we have learned so much from our own customers and our own product development journey about how to stay safe. So, we created what we hope is a simple and easy guide for COVID-19 protection."
In addition to raising public awareness, ZVerse is recommending its model to city and state officials looking for an easy way to keep citizens safe.
"ZVerse has been a valuable member of South Carolina's business community for many years, and they really stepped up when they received the call to help combat the COVID-19 pandemic," said Columbia Mayor Steve Benjamin. "Their "Good-Better-Best" model is exactly what we need to not only further the decline of COVID-19 cases, but also build toward a return to normalcy where we work, learn and play in our local communities."
ZVerse designs, manufactures and sells a complete line of acclaimed PPE products popular with consumers, schools, employers and government entities - and often seen covering famous faces across Hollywood
For information about ZShield products and pricing, visit: https://zshield.com/collections/available-products.
ZVerse was founded in 2013 by John Carrington in Columbia SC. ZVerse, a digital manufacturing ecosystem, currently provides the only CAD as a Service (CADaaS) platform and designer marketplace. ZVerse recently launched the next generation of its Digital Manufacturing Enablement (DME) platform, an AI drive workflow solution - a category defining technology for digital manufacturing and OEMs. In 2020, in response to the COVID-19 pandemic, ZVerse adapted its business model to quickly produce and distribute its new personal protective equipment product, ZShield, to hundreds of thousands of citizens. To learn more visit zverse.com and zshield.com.
Life sciences executive named to national NAMB Board see more
Nephron Pharmaceuticals Corporation today announced CEO Lou Kennedy as a new member of the National Association of Manufacturers Board of Directors.
Kennedy, who was elected on Monday, joins the NAM Board to bolster the association’s leadership in policy advocacy, workforce solutions, legal action, operational excellence and news and insights. She will help the industry advance an agenda that promotes growth and prosperity for all Americans.
“I could not be more excited and honored to join the board,” said Kennedy. “Our team has been fortunate to work with NAM over the last few years on critical issues, from COVID-19 to workforce development, and we are always impressed by the results NAM delivers for its members, as well as for employers and employees across the nation.”
NAM and its members are at the forefront of every important policy debate for manufacturers and have led the nation’s response to COVID-19.
Board members play a key role in the NAM’s “Creators Wanted” campaign, a member-driven initiative to inspire and drive more Americans to pursue careers in modern manufacturing.
“Lou Kennedy is a recognized leader in our industry, and the NAM will be stronger thanks to her service on our Board of Directors,” said NAM President and CEO Jay Timmons. “Manufacturers are the driving force behind our economic recovery and our fight to defeat COVID-19. We are working with lawmakers to ensure they deliver the relief America needs and the long-term policy work on issues like infrastructure investment, immigration reform, trade expansion and workforce development. We will also defend the progress we’ve made on tax reform and regulatory certainty to ensure we can keep our promises to invest in our people and communities and build the strongest economy possible. The NAM’s mission is to ensure we always keep moving forward, and Lou will bring invaluable insights as we advocate for the men and women of our industry and advance the values that have made America exceptional and our industry strong — free enterprise, competitiveness, individual liberty and equal opportunity.”
A West Columbia, S.C.-based company, Nephron is a nationwide leader in the development and production of safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. The company recently opened a CLIA-certified diagnostics lab, conducts COVID-19 tests and administers vaccines. Nephron announced a new $215 million investment and expansion in July, signaling a new era of unprecedented growth, including the establishment of a vaccine production facility.
The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 63% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.
Nephron, Lexington County businesses step up again see more
WEST COLUMBIA — Nephron Pharmaceuticals CEO Lou Kennedy watched proudly from her office window as a company security guard rushed out to help a woman with a hot pink walker from her vehicle into the West Columbia drug company’s headquarters.
Having found the location on the state Department of Health and Environmental Control’s website, the woman was there to receive a COVID-19 vaccine.
Nephron, along with Cayce-based Dominion Energy and two Lexington County road sign companies, Stay Alert Safety Services and Optec Displays, are donating time and services to put on a free drive-thru vaccine clinic. Eligible participants, age 65 or older, must have an appointment to receive a shot.
“I’m so proud we can do this,” Kennedy said.
While the vaccine itself is free, providers are legally able to bill people or their insurance for the doctor or pharmacy visit. Nephron is not charging.
With about 30 nurses on staff and almost as many doctors of pharmacy, the West Columbia drug maker applied for the certification needed to give the shots and administered its first 500 doses to Lexington County seniors inside its building over the week of Feb. 1.
It has 1,000 more doses to start giving out on Feb. 8, this time without people having to get out of their vehicles in an effort to make recipients more comfortable, Kennedy said.
When she first had the idea, she called Keller Kissam, president of electric operations at Dominion Energy South Carolina, to ask if they could use the power company’s vehicle turnaround area. Dominion’s headquarters a 10-minute drive from Nephron.
“Keller didn’t even hesitate,” Kennedy said. “It was ‘What can we do? How do we help?’ You talk about community spirit.”
In addition to the drive-thru space, Dominion is providing power to the site to power the computers needed to make appointments for recipients’ second doses. Stay Alert, Optec, as well as the town and county of Lexington are providing signage.
Those wishing to receive a vaccine from Nephron can go online to DHEC’s website in order to sign up for an appointment.
Robotics usage expands at Nephron see more
Two years ago, Nephron Pharmaceuticals brought a problem to the engineering and pharmacy colleges at the University of South Carolina.
When employees operating machinery at Nephron called in sick or otherwise couldn’t come to work, production is halted. Nephron CEO Lou Kennedy hoped the company and the two colleges could find a solution.
Kennedy is no stranger to the university, having graduated from USC. She and her husband Bill also established the Kennedy Pharmacy Innovation Center in conjunction with the USC School of Pharmacy.
However, she had not been a part of a collaboration with the university that actually shifted the way the West Columbia drug manufacturer operates.
After several classes of mechanical engineering students and pharmacy students worked to fix the problem, the project was finally completed this year— a robot named Smithers after The Simpsons character. The robot improves productivity by cutting out most of the human involvement in pre-filling sterile syringes with injectable medicines.
While Nephron has faster robots than Smithers, they require more human intervention.
“It just continues to make drugs without, frankly, a bathroom break or other things. So a steady machine, even if it’s slower, is better than people who haven’t shown up for the night and we have orders to fill,” Kennedy said.
Despite increased automation, Kennedy said employment will not be hurt. Nephron is currently in a hiring surge, trying to fill 380 positions including sterile pharmacy technicians and automation engineers. This year, Nephron will open its state-of-the-art vaccine production facility as part of a $215 million expansion.
“I can’t hire enough sterile pharmacy techs for what I need fast enough because of our growth, so this is just augmenting what we’re already doing— not to replace humans,” Kennedy said.
The robot consists of four pieces of equipment, all designed by students, that work together to mimic the actions of a human pre-filling sterile syringes, according to Nephron’s chief of engineering and USC mechanical engineering professor Ramy Harik. Separate pieces pick up the syringes, complete the filling process and cap the syringes to seal them.
Harik led three different teams of senior engineering students over two years to create the robot, while pharmacy students made sure the medical and sterilization aspects of the robot was safe for future human injection. The teams tested nearly ten different designs before finding one that worked.
The machine, which was installed last week, is being validated for commercial use and should be up and running in a couple of weeks, said Kennedy. She has already ordered the parts to make another one to put into production and hopes to have several of them going at the same time one day.
“My dream for the university is that we could commercially market these robots for hospitals around the world,” said Kennedy. “If we had the ultimate dream, it would be to sell these and a portion of the proceeds go back to the pharmacy and engineering school and allow us to endow a scholarship for future research.”
From the partnership, Harik created a pharmaceutical manufacturing class at USC for the next semester, and Nephron donated the equipment needed for students in the form of a glass cleanroom. The room allows students to work in a sterile environment for pharmacy manufacturing.
“Usually an entry-level engineer wouldn’t be given the opportunity to build an entire system from the ground up and it’s just been a great opportunity,” said John Diamond, one of the engineering students who started the project and now works at Nephron.
Enzyme and protein biotech leader creates, manufactures, distributes next gen products see more
IRMO, S.C. -- January 26, 2021 -- Integrated Micro-Chromatography Systems, Inc. (IMCS), known for their expertise in developing recombinant proteins and enzymes, has been awarded a $900,000 Small Business Innovation Research (SBIR) Fast-Track grant from the National Institutes of Health (Developing Chemoenzymatic Strategies, Enzymes, and Kits for Accessible and Affordable Gangliosides).
Under this grant, IMCS expands enzymes, reagents, and methods for animal component-free manufacturing of various gangliosides. This award funds research into the production of affordable gangliosides and kits that will enable researchers to establish the potential of ganglioside-based diagnostics and therapeutic interventions. The grant will be headed by L. Andrew Lee, Ph.D., co-founder and Chief Scientific Officer of IMCS in conjunction with Xi Chen, Ph.D., Professor at the Department of Chemistry, University of California, Davis.
Gangliosides are biomolecules that contain sugars and a particular type of lipids, or ceramides. Analogous to biological antennae in cells, gangliosides are involved in critical roles across multiple biological processes, making them ideal for therapeutic applications. With this research grant, IMCS will provide the broader scientific community access to affordable reagents and tools to synthesize and modify various gangliosides, thereby enabling researchers to understand how these biomolecules affect neurological functions.
Ronald Schnaar, Ph.D., Professor of Pharmacology at the Johns Hopkins University School of Medicine likened the grant’s approach to building Legos. Schnaar, who is not involved in the grant, said that the technology presented features a very flexible system that would allow scientists to use molecular building blocks called glycans, to create a library of various gangliosides that could be used for a wide variety of research applications. “If you give us the pieces to build the Lego [structure], we can generate the tools to study anything from cell activity to testing potential therapeutics. You can use this to build anything. You can build a mimetic library.”
In addition to its portfolio of enzymes, IMCS provides technologies to pharmaceutical companies, academic medical centers, and contract research organizations to develop next-generation antibody and gene therapy technologies, such as those used to fight the COVID-19 pandemic.
Research reported in this press release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R44GM139441. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Integrated Micro-Chromatography Systems, Inc (IMCS) is a privately held biotechnology company that strives to address the growing needs of clinical and research laboratories through innovative technologies and custom solutions designed to increase testing efficiency. IMCS creates, manufactures, and distributes next-generation biotechnology products to clinical and forensic toxicology, academic research facilities, US Federal Government agencies, and health science companies in North America, Europe, and the Asia Pacific Region.
Company Excited to Expand Generic Portfolio see more
WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation is celebrating another milestone.
The company today announced Food and Drug Administration (FDA) approval of the Nephron Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials. The vials are made of polypropylene plastic with a “luer lock” interface for needle-free dosing and are manufactured using Blow-Fill-Seal (BFS) technology.
Ketorolac Tromethamine becomes one of the first ANDA-approved non-respiratory generic medications produced by Nephron, signaling a new phase of company growth. Nephron secured FDA approval for Sodium Chloride IV Bags earlier this year.
“We are extraordinarily excited to expand our generic medication portfolio to include non-respiratory products,” said Nephron CEO Lou Kennedy. “This is the latest sign that Nephron is growing, and it represents a real reason for our entire team to celebrate.”
Nephron-manufactured Ketorolac Tromethamine is an injectable medication for the short-term treatment (up to 5 days) of moderately severe acute pain. Commonly used after surgeries and other medical procedures, Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID).
A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products.
The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. The company recently opened a CLIA-certified diagnostics lab and conducts COVID-19 tests for people across South Carolina.
Prescribing information for Ketorolac Tromethamine Injection Vial UPS, 60 mg/2 mL (30 mg/mL) is available on the product package insert. More product information regarding Ketorolac Tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials is available here
South Carolina's Rhythmlink acquires California-based med device manufacturer see more
COLUMBIA, SOUTH CAROLINA – Rhythmlink International, LLC is pleased to announce an exciting new investment, the acquisition of Chalgren Enterprises, a California-based medical device manufacturer that will add to their already extensive portfolio of products for brain and nervous system monitoring.
As a market leading designer and manufacturer of disposable neurodiagnostic devices and consumables, Rhythmlink has been quickly growing, even during an otherwise challenging year. Chalgren Enterprises provided another growth opportunity with a close alignment of culture, values, and product manufacturing expertise. The acquisition was completed on December 11, 2020.
“Chalgren is a good fit for our first acquisition both because of their experience in our industry and the way our cultures and missions align,” said Shawn Regan, CEO and Co-Founder of Rhythmlink. “Even with minimal changes we believe within the first year we’ll be able to take the Chalgren line of products and apply our manufacturing and sales best practices to see extensive growth.”
Chalgren Enterprises has been manufacturing electrodes for neurodiagnostics, specializing in EMG electrodes, for over 50 years. For the last 30 years Chalgren has been run by the father and son team of Richard and Michael Kaiser, who have seen the industry evolve from reusable to disposable products, product innovations, and a host of market and regulatory changes that have defined neurodiagnostic medical devices. Their reputation in the EMG market especially made them an appealing partner for Rhythmlink.
“Chalgren’s extensive experience is a good match for our innovation and steady growth,” said Regan. “Taking on their EMG products and legacy knowledge of EEG is a natural fit for our existing product lines and helps us encompass the full need of products that connect patients to machines.”
With the acquisition of Chalgren, Rhythmlink International will now offer products for epilepsy monitoring, electroencephalography, electromyography, evoked potentials, polysomnography, intraoperative monitoring and more, better serving the needs of neurologists and critical care providers through one company.
Regan concluded, “The culture we have built at Rhythmlink and our reputation in the marketplace are incredibly important to us, and Chalgren comes to us with more similarities than differences. We wanted growth that would ensure this dynamic would stay intact, and we’re excited about the future of these products and our company.”
Rhythmlink International is a medical device manufacturing company specializing in devices that help connect patients to machines to record or elicit physiologic information. Rhythmlink designs, manufactures and distributes a variety of medical devices for intraoperative neuromonitoring, electroencephalography, evoked potentials, polysomnography, long-term monitoring epilepsy and critical care units. Founded by neurodiagnostic technologists and engineers in 2002, Rhythmlink enhances patient care worldwide by transforming medical device technology that links patients to equipment. Rhythmlink also offers custom packaging, custom products, private labeling and contract manufacturing services.
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.”