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  • sam patrick posted an article
    SCBIO, 3 life sciences companies highlighted in media reports see more

    Courtesy Greenville News/Gannett

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

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

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

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

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

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

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

     

    Clinical trials vital to vaccine development

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

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

    "It really was just a natural fit for us," Steve Clemons, VitaLink's CEO and president, said.

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

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

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

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

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

    Acker has received both shots since then.

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

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

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

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

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

     

    Packaging of Pfizer vaccines

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

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

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

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

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

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

     

    Vaccines could soon be filled in the Lowcountry

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

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

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

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

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

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

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

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

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

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

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

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

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

    "We're not getting reimbursed for any of this," Kennedy said. "We're doing this out of the bottom of our heart."

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

  • sam patrick posted an article
    Softbox a key player in battle to beat COVID see more

    Softbox, a leading global innovator and provider of passive temperature control packaging solutions for the pharmaceutical, life science and cold chain logistics industries, is proud to support Pfizer in the distribution of Covid-19 vaccines through the supply of a high-performance temperature-controlled parcel shipper developed specifically for ultra-low temperature applications.

    Softbox supported Pfizer with the development of the highly specialised and reusable ultra-low temperature (ULT) shipper to help them on the distribution of ultra-low temperature vaccines and storing them at Point of Use (POU) sites.  

    Ultra-Low Temperature vaccines, such as that developed by Pfizer – BioNTech, uses mRNA (messenger RNA) technology and must be stored at temperatures between -90°C to -60°C to ensure that the vaccine’s quality and efficacy is maintained. The ULT shipper is capable of maintaining the required temperature during shipping of Covid-19 vaccines between -90°C to -60°C for at least 10 days unopened.

    The highly innovative shipper utilises high performance insulation materials, incorporated in a robust and reusable construction, in conjunction with dry ice, to ensure long term ultra-low temperature control. Based on current guidelines, the Softbox ULT Shipper can be opened twice a day, for up to three minutes at a time. This allows clinicians at Point of Use (POU) sites to access the vaccine vials required for each day’s immunisation clinics without exposing the remaining vaccine stored within the shipper to ambient temperatures, thus ensuring integrity of the vaccine is maintained.

    When correctly managed, the ULT Shipper can be used to store vaccines for in excess of 30 days. Through a process called “Re-Icing” the dry ice in the Softbox ULT Shipper can be topped up ensuring maximum thermal protection of the highly temperature sensitive mRNA vaccines.

    “Softbox’s extensive knowledge and experience in temperature control packaging solutions and the cold chain industry was the right choice for us. They immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine, and quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.” said Tanya Alcorn, Vice President, Biopharma Global Supply Chain for Pfizer. “Their technical capabilities and innovative approach helped us achieve an excellent result in a very short period of time.”

    Kevin Valentine, CEO of Softbox, said: “We are immensely proud to be playing such an important role in the fight against Covid-19. We worked extremely hard during 2020 to help Pfizer develop this highly innovative ULT shipper; establishing one of the world’s largest fleets of reusable temperature-controlled parcel shippers in the process and setting up two world-class service centres to support ULT shipper refurbishment.”

    “It’s a huge honour to have the opportunity to support the distribution of these vital vaccines at the right temperature, maintain their integrity and help save millions of lives.” 

    For more information about Softbox visit: www.softboxsystems.com

    About Softbox
    Softbox is an award-winning temperature control packaging innovator that has been designing and producing high performance passive temperature control packaging solutions for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout Europe, North America, Latin America, India and Asia Pacific.

    We have formed long standing partnerships with the world’s leading pharmaceutical, clinical research, biotech and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive clinical trial and commercialised products.

    For more information about Softbox visit: www.softboxsystems.com