Blood centers: U.S. facing critical shortage

COVID-19 impact on blood drives 

Blood donations are plummeting from coast to coast and putting a wide range of patients at risk, according to a joint statement by the organizations that provide virtually all the civilian blood needs in the United States. 

“Since the early stages of the COVID-19 pandemic, the blood community has experienced unprecedented fluctuations in both supply and the need for blood,” the American Association of Blood BanksAmerica’s Blood Centers and the American Red Cross said in statement.  

“A variety of events — including wildfires in the western states, recent hurricanes and other storms — have led to additional disruptions to the collection of blood, compounding the impact of canceled blood drives at schools, businesses and community organizations due to remote work and closures.” 

South Texas is experiencing the same critical shortages. The South Texas Blood & Tissue Center needs about 500 donations a day to keep up with requests from hospitals – but is averaging just 300 donations a day. Without a significant increase in blood donations, hospitals are at the point of making difficult choices on who they can treat with limited resources. 

Much of the decline can be attributed to the cancellation of more than 1,000 community blood drives, and thousands of lost blood donations, this year because of the COVID-19 pandemic. Normally, 70% of donations in South Texas come from community drives. 

As a result, the South Texas Blood & Tissue Center only is able to provide half the critically needed type O blood requested by hospitals. 

Donors can call 210-731-5590, or visit SouthTexasBlood.org to make an appointment at one of the South Texas Blood & Tissue Center’s seven donor rooms or locate a blood drive.  

Blood collections typically increase during the fall from high school and college drives, but fewer than half the usual school drives are scheduled through the end of the year. 

In normal times, when donations decline, blood centers help each other with shortfalls. But centers today have no donations to share. 

Blood donations are needed for a range of treatments, from cancer to trauma to childbirth, even during the pandemic. The impact of COVID-19 and the upcoming flu season could further compound challenges, the national statement said. 

“Blood donors are needed now to help maintain the adequacy of the blood supply and to ensure that blood is available,” the statement said. “Blood donors are needed now 

and will continue to be needed to ensure patients continue to have access to blood throughout the remainder of 2020.” 

Community blood banks, including the South Texas Blood & Tissue Center, have put numerous protocols in place to keep donors safe, from mandatory masks to social distancing to appointment-only donations. All donations are tested for COVID-19 antibodies. 

To make an appointment at a donor room or blood drive, donors can call 210-731-5590 or visit SouthTexasBlood.org  

QualTex Launches Cellular Therapy Testing Services

Lab to support researchers developing new treatments for global healthcare market

QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, has expanded its offerings to include cellular therapy testing services in support of advanced therapeutics clinical developers.

The new service provides a full range of research use only (RUO), current good manufacturing practices (cGMP), and good laboratory practices (GLP) qualified assays to support a variety of cellular therapy industry testing needs.

The cellular therapy testing service will allow QualTex to collaborate with clients to get their products to market, while at the same time adhering to the strictest quality standards. Through these collaborations, QualTex will work to develop new assays for the next generation of lifesaving treatments. 

“Every client and every project is unique. Our team’s goals are simple – be nimble enough to meet the needs of clients and at the same time follow the quality practices that are at the core of our organization,” said Ward Carter, Chief Operating Officer of QualTex Laboratories.

The laboratory can expand cell samples and either perform testing in-house or work with partner laboratories to provide a certificate of analysis, as well as individual test reports. 

This new QualTex service offering includes: 

  • Analytical assay development
  • Cell line characterization
  • Expandability and potency testing 
  • Lot and final release assays 
  • Stability testing 

“We have quality processes in place allowing us to provide phase-appropriate and risk-based testing solutions assuring the safety, purity, and potency of cell-based products,” Carter said.

Martin Landon, Chief Executive Officer of BioBridge Global, added “The launch of our cellular testing services provides another expansion to our end-to-end capabilities supporting regenerative and personalized medicine here in San Antonio and across the globe.”

Quick Community Labs launch possible only through local cooperation

COVID-19 testing facility based at BioBridge Global receives $1 million boost 

Getting the Community Labs COVID-19 testing program up and running in just three months is a testament to the collaborative nature of the San Antonio healthcare community, leaders of the efforts said in a panel discussion during San Antonio City Fest on Thursday. 

“I’ve never seen anything like this in my many decades in the field,” said BBG Chief Medical Officer Dr. Rachel Beddard, who played a major role in getting the testing laboratory established. “It was honor to be a part of it, and I am proud of what our city and our team have accomplished.” 

Organizers of Community Labs, led by former Rackspace chairman Graham Weston, were able to go from an idea over lunch in July to more than 1,700 tests of students and staff in the Somerset Independent School District as of Thursday. 

The tests are designed to identify individuals carrying and spreading the coronavirus that causes COVID-19 who do not have symptoms, what Weston refers to as “super-spreaders.” 

The short-term plan is to scale up testing in a lab located on the third floor of the BioBridge Global Headquarters Building, using widely available equipment and testing materials to avoid supply chain issues that have hampered other testing efforts. 

Community Labs received a boost this week, Weston announced during the panel discussion, when Carlos Alvarez, chairman and CEO of The Gambrinus Company, pledged $1 million to double the current testing capacity of the lab from 12,000 to 25,000 tests a day. 

“Our goal is to test 100,000 kids in schools,” Weston said. “If we test 100,000, we can make school the safest place these kids can go.” 

He noted that there have been four positive tests so far out of 1,786, four cases that could have spread quickly if those with it displayed no symptoms. 

Dr. Beddard said she greeted the idea of BBG becoming a partner in Community Labs with great enthusiasm, calling it “one of those aha moments, where you definitely realize you want to be part of something.” 

“We do a lot of testing here already – this year, we will do 60 million high-throughput, fast turnaround tests,” she said. “We also have a lot of experience with PCR testing, which means we can do it quickly to meet the need for the 24-hor turnaround time.” 

Community Labs is just the second lab in the country to receive the go-ahead from the Food and Drug Administration to conduct the highly accurate PCR tests at a sensitivity level high enough to identify a large percentage of positive tests, Weston said. 

The nonprofit lab’s long-term goal is to scale up to high levels of testing at an affordable cost — $35 per test at the moment, compared to $150 for comparable PCR tests – and then share what it learns about the process so labs can be established across the state and nation. 

“Were turning every bit of information we learn to anyone who asks about it,” said Tullos Wells, Managing Director of the Kronkosky Charitable Foundation and one of the co-founders of Community Labs, along with Weston and Bruce Bugg, Chairman of the Tobin Foundation. “We want everyone to do this assurance testing so kids will be safe to go back to school and their parents can go back to work.” 

Wells called the effort “the most consequential thing the Kronkosky Foundation has done in the last 25 years.” 

Weston said the collaboration to get Community Labs up and running was a testament to the collaborative spirit in the local medical community. 

“It’s a great San Antonio story,” he said. 

Scientists struggle to develop artificial blood

Despite 150 years of research, major roadblocks keep scientific ‘Holy Grail’ out of reach.

Scientists refer to artificial blood as the “Holy Grail” of trauma medicine. They have been trying to develop it for 150 years, and the history of that research is littered with failures.

That’s why you hear us say “there is no substitute for blood” at the South Texas Blood & Tissue Center. Right now, there isn’t one.

Narrowing the functions

Blood performs a wide range of functions in your body. That complexity makes it difficult to replicate in the laboratory, which is why efforts have focused on single functions like the delivery of oxygen and removal of carbon dioxide from cells.

In 2009, three researchers published an article, “A Review of Blood Substitutes: Examining The History, Clinical Trial Results, and Ethics of Hemoglobin-Based Oxygen Carriers,” that looked at the history of the issue.

The problem: The compound that carries oxygen and removes carbon dioxide is hemoglobin, which is carried within red blood cells.

By itself, hemoglobin can raise iron to toxic levels within the body and lead to organ damage, strokes and heart attacks. Multiple studies have not moved beyond the first stage of clinical trials because of the dangers.

Artificial blood has been seen as a solution to some of the issues related to transfusions, in both emergencies and as a long-term therapy. But the major issues remain to be overcome, as noted in an article from Stat News in 2017.

“The quest to develop substitute blood has bedeviled researchers in academia, the military, and the biopharma industry, with several companies abandoning their attempts,” he article said.

“The quest for the Holy Grail of blood substitutes remains unfulfilled,” the authors of “A Review of Blood Substitutes,” wrote. “However, if such a product can be developed, it will dramatically change both surgical and critical care medicine.”

FDA changes status of convalescent plasma program

New Emergency Use Authorization could make COVID-19 therapy more readily available to coronavirus patients

The Food and Drug Administration has changed the status of COVID-19 convalescent plasma therapy from a clinical trial to an Emergency Use Authorization.

The change should provide faster and easier access to the therapy by waiving some regulatory requirements before hospitalized patients with COVID-19 can receive transfusions of convalescent plasma.

Convalescent plasma is donated by those who have recovered from a COVID-19 infection and still have antibodies to COVID-19 in their blood. It is transfused to current patients, possibly providing passive immunity via anti-COVID antibodies.

The South Texas Blood & Tissue Center is the only organization in San Antonio collecting convalescent plasma donations and distributing them to local and area hospitals. The community blood center began collections as part of a clinical trial being conducted by the Mayo Clinic.

The FDA noted in its announcement on Sunday that convalescent plasma “may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.”

Carabin Shaw PC and Wyatt Law Firm PLLC are sponsoring a program to give convalescent plasma donors with STBTC a $50 Visa gift card for donating. The cards are being supplied by the firms and are not funded by the South Texas Blood & Tissue Center, a subsidiary of BioBridge Global. The cards will be distributed while supplies last.

Anyone interested in donating convalescent plasma can contact the South Texas Blood & Tissue Center at COVID19@SouthTexasBlood.org or visit SouthTexasBlood.org.

STBTC is taking donations by appointment only at the Donor Pavilion in San Antonio and its donor room in Victoria.

Plasma donors also must meet all other requirements to give blood.

The Emergency Use Authorization allows the distribution of convalescent plasma for its use by health care providers to treat suspected or laboratory-confirmed COVID-19 patients.

The Mayo Clinic recently reported data from 35,000 patients treated with convalescent plasma in its clinical trial. The report said there were fewer deaths among people given plasma within three days of diagnosis as well as those given plasma with the highest levels of antibodies.

The FDA’s Emergency Use Authorization authorizes the use of COVID-19 convalescent plasma, but its use has not been fully approved or licensed by the FDA.

The Emergency Use Authorization allows its use “only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic,” under federal law, the FDA stated, “unless the authorization is terminated or revoked sooner.”

‘Voices of Hope’ webinar educates community about COVID-19 convalescent plasma

The Blood & Tissue Center Foundation’s “Voices of Hope” webinar series demonstrated the value of COVID-19 convalescent plasma for an online audience recently.

Providing Hope: The Role of Convalescent Plasma in the Battle Against COVID-19” featured News 4 San Antonio anchor Delaine Mathieu as the moderator and included Elizabeth Waltman, Chief Operating Officer of the South Texas Blood & Tissue Center; and community leaders Gordon Hartman and Paul Basaldua.

Both Hartman and Basaldua have recovered from COVID-19 and are promoting plasma donations. Basaldua also has made multiple plasma donations.

Independent U.S. blood centers lead way in convalescent plasma donations

Blood centers across the United States, including the South Texas Blood & Tissue Center, have committed to doubling the number of convalescent plasma doses given to COVID-19 patients next month.

The announcement came during a convalescent plasma roundtable hosted by the White House. The event was described as a “national call to action” to encourage donation by Americans who have recovered from COVID-19 and have antibodies that can help current patients fight the virus.

Members of America’s Blood Centers, including the South Texas Blood & Tissue Center, collect more than 60% of the nation’s blood donations. They have provided 100,000 of the 124,000 doses of convalescent plasma transfused since the program began this spring.

“We’re not slowing down in any kind of way – indeed, we’re mobilizing to do even more,” said Kate Fry, Chief Executive Officer of America’s Blood Centers.

“We are projecting we will double our current number of doses by the end of August.”

The South Texas Blood & Tissue Center, a subsidiary of San Antonio nonprofit BioBridge Global, has provided more than 4,400 of those doses and has a goal of collecting from 75 donors a day by the end of August.

That would translate to about 260 doses a day, since an average donor can provide approximately three to five doses of plasma per donation.

The roundtable, which was moderated by President Donald Trump, included leaders from industry and the government working to boost convalescent plasma donations. A recording of the session is available at https://youtu.be/SxG-X15xLGk.

“We’re here to encourage more and more people to see (plasma donation) as something important and practical they can do during this global pandemic,” said Francis Collins, Director, National Institutes of Health.

Convalescent plasma has been called a bridge therapy – one that appears to be helping multiple patients – until an effective vaccine is approved.

The South Texas Blood & Tissue Center is the only organization in this area collecting convalescent plasma that can be transfused directly to patients with COVID-19.

Potential donors can find out more by visiting SouthTexasBlood.org or emailing COVID19@SouthTexasBlood.org. All donors must contact the center and be screened for COVID-19 antibody levels and symptoms before donating.

STBTC is taking donations by appointment only at the Donor Pavilion in San Antonio and its donor room in Victoria.

“With the widespread usage of convalescent plasma, it is a safe therapy for those with COVID-19 and it shows promise in helping patients,” said Dr. Samantha Gomez Ngamsuntikul, Associate Medical Director at the South Texas Blood & Tissue Center. “It is essentially a bridge between getting a vaccine or some other therapy.”

The community blood center and local hospitals are part of a study led by the Mayo Clinic into the effectiveness of the therapy. Antibodies to COVID-19 in the plasma may provide passive immunity to certain patients with severe forms of the illness.

The concept of using plasma from recovered patients is not new. The first Nobel Prize in Medicine was awarded in 1901 to a German physician for his work in developing what was known then as “antiserum.” In 1934, a physician at a boys school outside Pennsylvania used plasma from a recovered patient to keep all the students from coming down with the measles.

Plasma from recovered patients has been used more recently to treat patients with Ebola and SARS.