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QualTex Laboratories adds Ortho Diagnostics VITROS® Anti-SARS-CoV-2 IgG assay

Test detects antibodies developed during a COVID-19 infection 

QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, has begun offering the Ortho Diagnostics VITROS® Anti-SARS-CoV-2 IgG assay for use in detecting COVID-19 antibodies. 

The assay helps health care professionals determine if a person’s immune system has developed antibodies to the virus that causes COVID-19. It was approved for Emergency Use Authorization for qualifying COVID convalescent plasma (CCP) by the Food and Drug Administration on Aug. 23. 

Given the recent increase in COVID-19 cases and hospitalizations, the addition of the assay is a timely addition in the battle against the pandemic. 

The FDA has issued an EUA for COVID convalescent plasma, which is donated by those who have recovered from COVID-19, for use in patients with active COVID-19 infections. 

The Ortho IgG test has demonstrated 100% specificity and is currently the only assay approved by the FDA for COVID convalescent plasma qualification. The test runs on Ortho’s high-throughput, fully automated analyzers, and it measures IgG antibodies to the SARS-CoV-2 virus. 

COVID Convalescent plasma is currently being used to save the lives of those most severely affected by COVID-19. This assay provides a powerful tool to identify those blood donors with the highest antibody concentrations to aid in COVID-19 treatment.

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.”

GenCure joins with Sentien Biotechnologies, Rooster Bio on $2.4 million contract

Partners will develop potency assay for mesenchymal stromal cells

The federal Medical Technology Enterprise Consortium (MTEC) has identified the need for potency testing as critical to new cellular therapies.

Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, has been awarded a $2.4 million contract from MTEC.

GenCure and RoosterBio, which is a developer of MSCs and bioprocess media, are partners with Sentien Biotechnologies in the contract.

Together, this team will develop a potency assay framework using MSCs, spanning large-scale biomanufacturing, in vitro assay development and in vivo biomarker analytics. 

The award was granted by the U.S. Army Medical Research & Development Command (USAMRDC) in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). 

The Defense Health Agency has identified a need for quality management in the biomanufacturing of regenerative medicine-based products. For cell therapy products, the potency assay is the most robust quality metric, representing the biological ability of a product to effect a clinical outcome. Developing a potency assay is a complex challenge, requiring significant characterization of process parameters and quality attributes throughout the preclinical and clinical development stages. 

This work will take an integrated, cross-functional approach to potency assay development. First, biomanufacturing process parameters and quality attributes will be evaluated during the expansion of MSCs derived from different tissue sources. Second, the resulting cell banks 

will be analyzed using Sentien’s ex-vivo bioreactor platform to assess the immunomodulatory effects of the MSCs and generate putative potency markers. Finally, the putative potency markers will be matched against clinical trial samples from subjects with systemic inflammatory conditions who have been treated with SBI-101, Sentien’s lead product. 

SBI-101 is a combination biologic product, in which MSCs reside on the exterior of hollow fibers, while blood flows through the interior. The unique design of SBI-101 enables real-time sampling of both MSC-secreted factors (pharmacokinetics) and their effect on patient blood (pharmacodynamics), which will provide particular value for this project. The ultimate goal of the project is to develop a broadly applicable potency assay framework that members of the regenerative medicine community can leverage for their particular biomanufacturing process, product and indication of interest. 

“Sentien is grateful to MTEC and the DoD for recognizing the potential impact of our proposal and awarding the funds to undertake this work. We have an opportunity to add real value to the regenerative medicine community by developing this potency assay framework which spans R&D, biomanufacturing and clinical translation,” said Chris Gemmiti, Senior Vice President of Operations at Sentien. “This award demonstrates external recognition of how our proprietary microreactor platform can offer unique insights into MSC biology. This is very timely as the interest in MSCs has been increasingly heightened in the context of COVID-19 trials,” said Rita Bárcia, Vice President of R&D at Sentien. “We are very excited to be partnering with RoosterBio and GenCure on this project,” added Sentien CEO, Brian Miller. “We believe this team of collaborators, with complementary technologies and skills, will together produce a valuable, widely applicable deliverable.” 

“We are very much looking forward to this collaboration to provide our platform solutions and expertise in MSC manufacturing in support of this project,” said RoosterBio CEO, Margot Connor. “The development of a MSC potency assay framework is really the cornerstone of a successful regenerative medicine product thus we are grateful for the opportunity to contribute to this team effort.” 

Becky Cap, Chief Operating Officer for GenCure, a subsidiary of BioBridge Global, commented, “GenCure values creative approaches to solving difficult problems, and the Sentien team has developed some highly innovative approaches to treatment with SBI-101. With this project, they are finding ways to leverage that innovation to address more fundamental questions about potency and the impact of tissue source on both potency and therapeutic benefit. We are honored to be part of this project.” 

“Laboratory in a box”: Community Labs rapidly ramps up COVID-19 testing

Community Labs soon will be performing up to 10,000 COVID-19 tests a day and expects to reach capacity of 20,000 or more per day by January, BioBridge Global executives told members of The Blood & Tissue Center Foundation board of directors on Monday.

The organization, which is a nonprofit partnership among local charitable foundations and BioBridge Global, is expanding its community reach for its highly accurate test for COVID-19.

“The real focus is to get schools up and running,” said Richey Wyatt, General Counsel and Chief Compliance Officer at BioBridge Global, who noted that this week, testing was being expanded to seven school districts, mainly on the South Side.

Testing also is projected to start soon for the 300 employees of the state’s Child Protective Services in San Antonio, as well as Trinity University.

“When we started with Somerset ISD, we were doing 500 tests a week, and that ramped up to 500 tests a day,” Wyatt said. “We should have the capacity to be able to perform 10,000 tests per day within a couple of weeks.

“I’d say probably by January, we should be able to double that capacity to 20,000 to 24,000 tests a day.”

Community Labs, which is just the second high through-put “PCR” COVID-19 testing laboratory of its kind in the United States, is beginning to attract outside attention, with interest from officials in the hard-hit El Paso area, as well as Louisiana, Idaho and Georgia, Wyatt said.

All the technology and procedures the lab is using will be made available to anyone who asks, said Dr. Rachel Beddard, Chief Medical Officer at BioBridge Global.

“They’re calling it ‘laboratory in a box’” she said. “They are putting all the information together for any city that might want to do this.”

Community Labs is using the highly accurate PCR test, Dr. Beddard said, checking for three different genetic sequences from the coronavirus that causes COVID-19.

“Some PCR tests look for just one or two, but this one looks for three,” she said. “It’s one of the most sensitive tests out there.”

The tests are designed to identify the so-called “silent spreaders” of COVID-19, individuals who do not have any of the common symptoms. The goal is to make testing much more economically feasible, at just $35 a test vs. $150, and provide a turnaround time of less than 24 hours, to help stop the spread of the virus.

More information about Community Labs is available at CommunityLabs.org and on the BioBridge Global website.

Blood centers across nation report critical shortages

Independent blood centers from coast to coast are facing critical shortages, according to information compiled by their trade association.

Of the 59 organizations in America’s Blood Centers, which includes the South Texas Blood & Tissue Center, just 12% are reporting what is considered a normal level on blood available for patients – enough to meet needs for three or more days.

Centers reporting a two-day supply are considered to be running low and need donors.

Those with one day’s supply or less are considered critically low and need donors immediately.

In a recent survey, 20% of centers reporting their statistics were at one day’s supply or less.

During the Thanksgiving holiday, South Texas Blood & Tissue Center averaged around a 1-2 days supply for all blood types.

Current shortages are blamed on fallout from the COVID-19 pandemic: Canceled drives at schools, colleges, churches and businesses, which make up large portions of donations in a typical year.

Blood shortages mean doctors and hospitals are forced to delay treatments and make difficult decisions about who should receive a transfusion.

The South Texas Blood & Tissue Center needs donors to schedule appointments as soon as possible. Donors can visit SouthTexasBlood.org/Give or call 210-731-5590 to make an appointment at a donor room or blood drive.

Donors also can give at the University Hospital Blood Donor Room. To schedule an appointment with University Hospital, call 210-358-2812 or visit DonateBloodToday.com.

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. 

City of San Antonio expands COVID-19 testing to asymptomatic individuals at City’s no cost test sites

Beginning Monday, October 5, the City of San Antonio’s no cost testing sites will have a soft launch to expand testing to asymptomatic individuals.  The test sites are located at Freeman Coliseum, Cuellar Community Center and Ramirez Community Center. All locations will be able to provide testing daily starting October 12.

Monday October 5th from 10 a.m. to 11 a.m.

Cuellar Community Center
5626 San Fernando St.

San Antonio, TX 78237

Tuesday, October 6th from 10 a.m. to 11 a.m.

Ramirez Community Center

1011 Gillette Blvd.
San Antonio, TX 78219

Wednesday, October 7th from 9 a.m. to 10 a.m.
Must schedule an appointment at 830-391-8559

Freeman Coliseum

3201 E. Houston St.
San Antonio, TX 78219

The testing expansion is a partnership between Metro Health, Community Labs and BioBridge Global.

“Throughout this response, our goal has been to make testing more accessible by leveraging partnerships with our community and relying on CDC guidance for testing. Over the past few weeks, we’ve been looking at ways to bring FDA-approved, asymptomatic testing to our City’s test sites and I’m so pleased to partner with Community Labs to make this a reality,” said Assistant City Manager and Interim Metro Health Director Dr. Colleen Bridger.
Previously residents were required to show symptoms of the disease, which included a fever, dry cough, chills, amongst other symptoms of COVID-19. Starting Monday, individuals with or without symptoms will be able to use the City’s no cost test sites to access nasal PCR tests at no cost to determine if they have contracted COVID-19. Nasal PCR tests have been approved by the FDA for testing of asymptomatic individuals.

“Community Labs was created to make sure every San Antonio resident has access to COVID-19 testing weather they are asymptomatic or not. We are pleased with this new partnership with the City of San Antonio and look forwarded to supporting them in this mission with us.” said Graham Weston, Chairman of the Board of Community Labs.

As a reminder to the public, after being tested for COVID-19, it is important to:

  1. Assume you are positive until you get your test results back.
  2. Stay at home in a room away from other people and use a separate bathroom if you can. Isolate yourself from others, including not going to work until results are received. If you are facing hardships to finding a safe place to isolate from vulnerable people in your household, contact 311.  
  3. Identify close contacts. A close contact is anyone you spent 15 minutes or more with and were within six-feet distance. If you test positive, call people or places that you had close contact with. Let them know that they were exposed and that they should quarantine for 10 days. To identify a close contact, work backwards until two days before you showed symptoms.
  4. Monitor symptoms at least twice a day. If you have a prolonged fever, difficulty breathing or chest pains, call your medical provider or 911 if there is an emergency.
  5. Wash your mask daily and be sure to only touch the ties/ear loops as the inside and outside may be contaminated.

In addition, the City of San Antonio has an online self-screening tool that can be found at www.sanantonio.gov/covid19. This tool does not replace medical care if a person is feeling ill. A healthcare provider should be visited if symptoms worsen or if underlying medical conditions such as diabetes, high blood pressure, lung disease, or heart disease is a factor in the person’s medical history.

For more information please visit the COVID-19 portal or https://www.communitylabs.org/ 

FOUR WAYS TO SIGN UP FOR COVID-19 ALERTS

  1. Download the Ready South Texas app, available in the iTunes and Google Play stores
  2. Text COSAGOV to 55000 to receive SMS text message updates
  3. Follow @COSAGOV on Facebook, Twitter and Instagram
  4. Bookmark covid19.sanantonio.gov

Public service announcements on physical distancing, prevention and testing are available here.

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.