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.”

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.”

‘Old’ science leads in fight against COVID-19

Convalescent plasma, first discovered in the 19th century, authorized for use in fight against coronavirus

A doctor’s reaction to a potential epidemic almost 90 years ago forms the basis for one of the few therapies for patients with COVID-19 today. That therapy was in the news recently, as the FDA issued an emergency use authorization for it on Sunday, Aug. 23, with the goal of making it more widely available.

Back in 1934, Dr. J. Roswell Gallagher, staff physician at a boys’ school near Philadelphia, knew he had to act fast when one boy came down with the measles, then gave it to two others in the school’s infirmary.

So he looked back to science from the turn of the 20th century. Research showed that “antiserum” – plasma, the liquid part in the bloodstream – could be used to prevent or treat diseases.

Gallagher collected and purified plasma from the first boy to recover from the measles and gave it to 62 other students.

Three developed mild symptoms. No one else got sick.

‘Antiserum’ therapy makes a comeback

As patients began suffering from COVID-19 earlier this year, Dr. Arturo Casadevall, chair of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health, remembered the lessons Gallagher had practiced decades ago.

Casadevall proposed bringing back “antiserum” – now known as convalescent plasma – as a treatment in an op-ed article in the Wall Street Journal in late February.

As reported on the Johns Hopkins University site The Hub, Casadevall’s idea spread quickly.

Teams were assembled, protocols were defined and groundwork was laid for a clinical trial using convalescent plasma to fight COVID-19, including the clinical trial being run by the Mayo Clinic, of which the South Texas Blood & Tissue Center is a part.

Warp speed deployment, results

A clinical trial at Methodist Hospital in Houston was established for the use of convalescent plasma on March 24. Less than a week later, the first patients received it.

The first dose was collected at the South Texas Blood & Tissue Center in early April and quickly transfused to a seriously ill patient— who has since recovered and now is eligible to donate himself.

Nationally, tens of thousands of patients have received convalescent plasma. A preliminary look at patient data by the Mayo Clinic showed a 50 percent decrease in mortality rates in patients receiving the transfusions, especially if they receive plasma soon after a positive test.

Athletic blood donors report fewer negative experiences

46-month research demonstrates safety of FDA guidance for low pulse rate population

Blood donors with low pulse rates experience fewer negative reactions than the general blood donor population, according to a review conducted at the South Texas Blood & Tissue Center.

Negative reactions – including things like bruising, dizziness or soreness – were reported in just 0.53% of donors who had a pulse rate of 50 beats per minute or less, compared to 3.36% of all donors during the same period.

Following the eligibility change, STBTC wanted to make sure blood donation was safe for donors with lower pulse rates.

Procedure

To follow the FDA guidance, the South Texas Blood & Tissue Center established this procedure:

  • When a donor was recorded with a pulse rate of 50 or lower, the phlebotomist contacted a nurse.
  • The nurse would evaluate the donor’s athletic activity and build, and make sure the donor had no cardiac issues.
  • The nurse would contact a physician, who would make the final determination about the donor’s suitability.

Just 13 reactions in low pulse rate donors were reported. None of the reactions were classified as severe.

“At STBTC, we want to ensure the safety of our donors,” said Dr. Samantha Gomez Ngamsuntikul, Associate Medical Director. “Donors with low pulse rates can donate safely.”

The research has been accepted for a poster presentation at the virtual AABB Annual Meeting.

Schedule a donation to give blood today by calling 210-731-5590 or visiting SouthTexasBlood.org/Give-Now.

San Antonio doctor encourages recovered COVID-19 patients to donate plasma

Dr. Jairo Melo, one of San Antonio’s biggest proponents of convalescent plasma treatments, has a simple message for anyone who has recovered from COVID-19.

“I encourage everybody – everybody – who has recovered to donate,” the Medical Director for Pulmonary and Critical Care with Methodist Hospital told The Blood & Tissue Center Foundation board at their online meeting Monday.

Dr. Melo has advocated for giving plasma from recovered patients to those hospitalized with COVID-19 since the early days of the pandemic. But he is seeing a trend as reported cases and the number of critically ill patients rise.

“The sicker people are, the more grateful they are – and those are the people who are donating,” he said, adding that those recovered patients’ families also tend to become regular plasma donors.

“The large number of people who don’t get admitted to the hospital don’t donate as much. We need them to give, too.”

He said a recent report that COVID-19 convalescent plasma is moving from being administered as a clinical trial to a standard of care for doctors – after more than 100,000 transfusions – has him encouraged.

He emphaized that anyone who has recovered needs to see if they can donate plasma. Potential donors can send an email to COVID19@SouthTexasBlood.org to set up an appointment for initial testing.

“COVID isn’t going anywhere,” he said. “If I see a patient with COVID, I want to give them convalescent plasma. It’s accepted by doctors as one of the few things we have to offer, so we need to focus on that.”

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.