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. 

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.”