Rise in auto accidents and other traumas is straining the South Texas blood supply. Help patients by scheduling your donation today!

Advanced therapies eyeing a steep upward curve

When Adrienne Mendoza looks at the potential for growth of advanced therapies in South Texas Blood & Tissue Center, she doesn’t see just a gradual upward growth.

The Vice President of Blood Operations sees the possibility for a steep exponential growth curve because of recent clinical successes in cell and gene therapies and the interest by market leaders in sourcing donations of starting cells from South Texas Blood & Tissue Center.

“When you look at the potential for both new and existing customers developing these new therapies, each of these customers may find success in their clinical trials, and we will then see the next growth surge. It’s when our customers find success that we’re looking at the possibility for exponential growth,” she said.

STBTC Center for Advanced Therapies, along with GenCure and QualTex Laboratories, is part of the ever-­expanding field of cellular and immune therapies, assisting with various phases of research into therapies to cure chronic, debilitating and degenerative diseases.

“We’re already seeing more and more companies coming to us, and more of our existing customers bringing more projects to take on,” Mendoza said. “We are also seeing those customers provide referrals to others.”

The new department Center for Advanced Therapies includes the teams of life legacies tissue, cord blood and birth tissue, apheresis services and clinical research.

The Center for Advanced Therapies in STBTC is working with organizations developing new cell and gene therapies, helping researchers find cell donors to support each major stage of the clinical trials process that leads up to a new drug or biologic FDA approval.

The work includes building a database of donors interested in a chance to enroll in trials to support patients fighting for their lives and eager to see if donor cells can save their lives. Once selected, the donor is reimbursed for time and travel to support the trial. Anyone is welcome to sign up on the research study database.

“As Vivienne Marshall (Senior Director, Center for Advanced Therapies) puts it, we are now all about ‘care’ and ‘cure’ as an organization,” Mendoza said. “We take care of people who need blood donations, and now we’re helping advance research to cure diseases.”

STBTC already has supplied donations of specialized cells to several major clients, including for Phase 1 clinical trials for patients with cancers not responding to other treatments.

“When the trials progress to Phase 2, we’ll be providing even more donor cells – since the trials will expand to enroll more patients at more hospitals,” Mendoza said.

Cells from deceased donor tissue, as well as birth tissue, also have the potential to aid researchers in developing advanced therapies for a range of conditions from eye disease to cancer.

“It’s only a matter of time before this all starts to grow really fast,” Mendoza said. “Starting with our growth in the field, then all our existing customers growing, and finally new business growth. It just has worlds of potential.”

BioBridge Global continues history of innovation with umbilical cord collection and processing under cGMP standards for further manufacture

Stem cells from cord tissue to be used to develop new cellular therapies

BioBridge Global is committed to supporting advanced therapies through the development and delivery of services from source material collection, donor and product testing, development and manufacturing services and logistics management. This week, the organization fulfilled a promise to customers to collect, deliver and process an umbilical cord under current good manufacturing process (cGMP) standards for further manufacture into advanced therapies.

BioBridge Global has been collecting, testing, and delivering material under cGMP and/or cGTP for clinical use for more than 45 years. Birth tissues were added to that portfolio in 2016 for use in graft applications by numerous tissue processors.  Therapeutic developers of advanced therapies have been requesting tissue under cGMP for further manufacture for several years, having found no consistent and reliable source in the United States.

The complexities associated with donor qualification, tissue collection and tissue processing for umbilical cord tissue are far greater under these further manufacturing standards. Donor mothers must be exceptionally healthy, already have been identified to undergo a planned c-section, and then consented under an IRB-approved consent. The cord tissue, collected during the birth process, is then tested independently to ensure sterility of the product going into therapeutic development.  To deliver the best possible therapeutic product, the cord must undergo very specific preparation steps in a clean room environment before it is released for life-saving therapies. The processed cord, which is rich in stem cells, can eventually be manufactured into a combination of either intermediates such as a master cell bank or end-product advanced therapies to deliver directly to a patient.

South Texas Blood & Tissue collected the birth tissue from a donor who was determined eligible based on custom specifications as well as significant regulatory agency requirements for tissues used for further manufacture. QualTex Laboratories performed donor screening and sterility testing on the cell product, and GenCure conducted time-sensitive aseptic processing to ensure that the tissue-derived cell product could be preserved for maximum benefit for therapeutic development.

South Texas Blood & Tissue, QualTex Laboratories and GenCure are subsidiaries of San Antonio-based nonprofit BioBridge Global.

“This is a significant accomplishment for the entire organization and the teams involved,” said Martin Landon, Chief Executive Officer of BioBridge Global. “To the best of our knowledge, based on our review of the market and customer feedback, there is no source material provider in the United States delivering qualified birth tissue under cGMP for further manufacture into advanced therapies.”

Other organizations have programs using cells derived from umbilical cord, and various sources are available for early-stage research. But there were no consistent sources of cGMP collections and processing for further manufacture until BioBridge Global made its delivery.  The market demand came to BioBridge Global’s attention when it developed its biomanufacturing service line under GenCure.  A number of customers had approached GenCure, knowing about BioBridge Global’s donor material collection services, requesting development of processes to support collection and production of a cGMP cord product.

Dr. Rachel Beddard, Chief Medical Officer at Biobridge Global, led the development of the process. “This achievement is a perfect example of the cross-collaboration within our organization. South Texas Blood & Tissue, QualTex and GenCure joined efforts to set-up a program to provide umbilical cord tissue collected, tested, and aseptically processed, following GMP standards and compliant with U.S. and international regulatory requirements for further manufacture into advanced therapies.”

“Congratulations to the team that helped design and implement the collection and testing procedures, execute on those procedures to collect, test, and process the cord,” Landon said. “We are still steps away from therapies that will save and enhance lives, but we have built a foundation where none existed before.”

BioBridge Global and its subsidiaries have been collecting birth tissue, including umbilical cords, since 2016 and umbilical cord blood for therapeutic use since 2001. All donors consent to IRB-approved collection protocols authorizing the use of their donation for research, clinical, or commercial applications. 

South Texas Blood & Tissue Center opens helicopter landing pad

Helipad to resupply blood for emergency medical providers, aid in major trauma care 

To aid in the emergency use and delivery of blood in South Texas, the South Texas Blood & Tissue Center has built the first helicopter landing pad for a blood center in the state. 

The landing site, which is between the BioBridge Global Headquarters Building and its Annex Building on San Antonio’s northwest side, is designed to serve two purposes: 

  • Allow medical helicopters that carry specially screened units of whole blood to restock supplies as needed 
  • Provide a location for helicopters to pick up blood for delivery to major trauma events or natural disasters 

“Making this option available is just part of our commitment to saving lives,” said Adrienne Mendoza, Vice President, Blood Operations at the South Texas Blood & Tissue Center, a subsidiary of San Antonio-based nonprofit BioBridge Global.  “Since we serve such a large area, it just made sense to provide this to helicopter operators as an option.” 

The center helped launch a first-of-its-kind civilian system for using whole blood on helicopters more than two years ago. That system since has expanded to EMS units in multiple South Texas fire departments, including the San Antonio Fire Department, as well as hospital emergency rooms across the 40-plus counties the center serves. 

Specially screened type O-positive blood donations for the program come through the blood center’s Brothers in Arms program

“The landing pad also could help us quickly supply blood in the case of a mass casualty or weather event as part of the Blood Emergency Readiness Corps, the new national emergency blood supply system,” Mendoza said.  

Emergency deliveries could be made within the operating range of the helicopters to medical facilities or remote locations, she said. 

Previously, whole blood used on medical emergency helicopters was restocked via van delivery by the center’s Hospital Services team. (That option still remains open to the 12 agencies that operate the helicopters.) 

But helicopters often cannot wait at either of the city’s level I trauma centers because of the high cost of operations and the potential for additional emergency needs for the hospitals’ helipads. 

“We couldn’t always make those connections,” said John Barry, Director, Hospital Relations and Distribution for the blood center. “When they would go back without blood, then we would have to figure out that night or the morning after how we were going to get blood back to them.” 

Restocking by ground delivery wasn’t a major issue for local agencies, but the whole blood program also is on helicopters as far away as Laredo and Carrizo Springs. Having a place for those helicopters to land and restock before returning to base just made sense, he said. 

Barry, who was part of a similar system for whole blood use on medical emergency helicopters while in the military, worked with one medical helicopter operator to identify a location for the landing pad in a little-used parking lot. 

“We got on Google Maps (of the parking lots) and we put it on the big screen,” Barry said. “We said, ‘Well, you can land two helicopters here.’ That was how the plan started.”  

He then learned about the technical requirements, including lights, a windsock, a new asphalt base and markings, and the project was completed in less than a month. 

The idea originated during a meeting with the Southwest Texas Regional Advisory Council, an organization designed to develop, implement and maintain regional trauma and emergency healthcare system for 22 counties in South Texas. 

South Texas Blood & Tissue Center joins nation’s first emergency blood reserve

Partnership of seven community blood centers launches blood emergency program in commemoration of 20th anniversary of 9/11

The South Texas Blood & Tissue Center, a subsidiary of San Antonio nonprofit BioBridge Global, is helping to launch a first-in-the-nation partnership to ensure blood will be available in mass trauma situations and natural disasters. 

Blood centers have faced nationwide blood shortages as thousands of blood drives have been cancelled during the COVID-19 pandemic, straining the national safety net.  

While in the past, blood centers had inventory on hand to quickly share with other communities in a blood emergency, today this backup supply plan is increasingly unstable. As the primary blood supplier for the region, South Texas Blood & Tissue Center collaborated with other blood centers to create the new program to be proactive in emergency planning – both for mass trauma events that require large volumes of blood, and for natural disasters such as hurricanes that can cripple blood collections.

“The blood emergency program is an opportunity to engage socially minded individuals, community leaders and major employers to work with us and ensure blood is available in the case of mass trauma situations – whether that’s a major accident, a mass shooting such as Sutherland Springs, or a natural disaster such as a hurricane or the 2021 Texas ice storm,” said Adrienne Mendoza, Vice President, Blood Operations at the South Texas Blood & Tissue Center.

The Blood Emergency Readiness Corps is made up of blood centers from five states that have committed to collecting extra blood units on a rotating, “on-call” schedule. The extra blood products will be held in reserve for any critical-need scenario.

If no emergency situation arises, the blood products will be returned to South Texas Blood & Tissue Center’s general inventory, to be used for local needs.

“This is the first step in the right direction to being prepared for the unthinkable situation,” said Dr. Donald Jenkins, with UT Health/University Health System Trauma Care. “Being ready with a supply of blood for the communities is a great idea.”

The program includes the South Texas Blood & Tissue Center, We Are Blood (serving the Austin area), Carter BloodCare (Dallas), Houchin Community Blood Bank (Southern California), Oklahoma Blood Institute, the Community Blood Center (Wisconsin), and Central Pennsylvania Blood Bank.

The announcement of the partnership came on the 20th anniversary of the 9/11 attacks.

“While it is a solemn occasion, recognizing 20 years since 9/11, it’s probably very appropriate that we have the recognition that we are still in this together,” San Antonio Mayor Ron Nirenberg said.

To schedule a blood donation visit SouthTexasBlood.org or call 210-731-5590. You also may call University Hospital’s donor center at 210-358-2812 or visit DonateBloodToday.com.

BioBridge Global, Vitrafy Life Sciences join forces to advance new cryopreservation technology

San Antonio-based BioBridge Global and Australia’s Vitrafy Life Sciences partner to develop new cryopreservation systems for the advancement of human blood services and advanced cellular therapies.

BioBridge Global and an Australian company, Vitrafy Life Sciences, have signed an agreement set to revolutionize cryopreservation supply chains for human blood products and advanced cellular therapies.

Vitrafy Life Sciences’ novel cryopreservation supply chain solution has the potential to prevent the kinds of blood shortages currently seen around the United States and the world.

The agreement is set to develop protocols and methodologies utilizing the Vitrafy Life Science patented algorithm and supporting technology to improve the survival rates of blood and blood products during the cryopreservation supply chain process, while developing innovative new products that to date, cannot be successfully preserved.

The technology also will be used in advanced cellular therapies such as CAR T therapy, which have notoriously high manufacturing costs with low survival rates.

“This innovative technology aligns with BioBridge Global’s mission of saving and enhancing lives through the healing power of cells and tissues by enhancing the cold chain solution for a wide range of our products,” said Dr. Rachel Beddard, Senior Vice President and Chief Medical Officer at BioBridge Global.

“It is truly exciting to partner with Vitrafy to bring this game-changing technology to our country.”

Vitrafy Life Sciences, a startup launched in 2018, and BioBridge Global, which began operations as the local blood bank in 1974, were brought together by Cell Bridge Strategies and its Chief Executive Officer, Jane Andrews, Ph.D., who facilitated the collaboration.

Vitrafy Life Sciences is a new biotechnology company leading the way in innovative new patient orientated outcomes. Through its complex patented algorithm and supporting cryopreservation supply chain technologies, Vitrafy Life Sciences provide precise and consistent cryopreservation cold chain solutions, tailored for the individual cell line.

Vitrafy Life Sciences’ novel approach provides an opportunity to revolutionize the delivery of existing and emerging cell-based therapies from the research laboratory to the patient bedside.

“Cryopreservation supply chains haven’t seen technological advancements for decades,” said Vitrafy Life Sciences Co-Founder Brent Owens. “A post-COVID world needs better systems in place to ensure that a constant supply of blood products is always available for patients in need.

“Vitrafy Life Sciences is extremely proud to partner with such a reputable and ethical organization in BioBridge Global. We look forward to completing our regulatory approvals and moving into robust optimization of these lifesaving therapies.”

Cell Bridge Strategies is a San Antonio/Boerne, Texas-based international growth consulting firm that bridges science to business to create corporate strategies and advance product commercialization. 

BioBridge Global is a San Antonio, Texas-based 501(c)(3) nonprofit corporation that offers diverse services through its subsidiaries – the South Texas Blood & Tissue Center, QualTex Laboratories, GenCure and The Blood & Tissue Center Foundation.

BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. BBG is committed to saving and enhancing lives through the healing power of human cells and tissue. It enables advances in the field of regenerative medicine by providing access to human cells and tissue, testing services and biomanufacturing and clinical trials support.

Vitrafy Life Sciences Co-Founders Sean Cameron (left) and Brent Owens are pictured with one of the company’s devices developed for cryopreservation of biological materials.
Leaders from BioBridge Global, Cell Bridge Strategies and Vitrafy Life Sciences are pictured following a meeting at the BioBridge Global Headquarters Building in San Antonio, Texas. From left, Martin Landon, Chief Executive Officer, BioBridge Global; Jane Andrews PhD, Chief Executive Officer, Cell Bridge Strategies; Brent Owens, Co-Founder, Vitrafy Life Sciences; Anand Srinivasan PhD, Director, Innovation & BioDesign, BioBridge Global; and Scott Jones PhD, Vice President, Scientific Affairs, BioBridge Global.

Research & Development: Many paths, two guiding principles

Researchers and scientists at BioBridge Global are quietly working on everything from developing new assays to emulating the ways cells act in the body.

They’re coming up with novel solutions to laboratory issues. They’re working on treatments for traumatic injuries and chronic diseases and burns.

But amid the whirlwind of activity in the Headquarters Building, there are two guiding principles behind all the science, says Dr. Rachel Beddard, BBG Medical Director and head of Research and Development.

“First of all, we want to meet needs-fill gaps in services and provide good value to our customers,” she says. “And then, we try to be really good stewards of our donations.”

Much of the work is at a stage where it can’t be shared publicly yet. But there are multiple success stories coming out of the 11-member team, which is made up of one group focused on assays and development and another focused more on research.

The development team, led by Zeke Butler, completed a remarkable 15 nucleic acid assays in support of QualTex cellular therapy testing and GenCure biomanufacturing in 2020.

“Fifteen assays is a lot in one year – to develop, write the SOP, transfer it to cellular therapy testing and collaborate with them,” says Scott Jones, Vice President, Scientific Affairs.

The assays meet the need of regenerative and cell therapy researchers.

“They will need safety assays used to detect the presence of infectious agents,” Butler said. “These assays validated by BBG R&D will ensure that the starting and final material or products are safe for potential patient use after rigorous clinical trials and FDA approval.”

The research team, led by Anand Srinivasan, just moved into a brand-­new laboratory, Center for Innovations and Biodesign, on the first floor of the Headquarters Building.

The space they vacated will be renovated and dedicated to the development team for assay development, validation and clinical trial support.

Srinivasan and his team are working on new uses for donated cells, including expired platelets and type 0, A and B plasma, among other projects.

A large part of their work is an outgrowth of medical research done by the U.S. military, including the use of amniotic tissue as a “living bandage” for body wounds and eye injuries.

Even the more-theoretical research, including a remarkable and complex device the team has built to look into how the body reacts to cells, has a real focus, Jones says.

“We always are doing research with a specific goal in mind,” he says. “Anand does a lot of mathematical modeling. The whole concept is to do nothing without working out a formula first. We use the formula to narrow it all down to a handful of factors. “It’s working smarter, not harder.”

The approach is producing results and earning BBG new business.

Testing strategies and custom assay development for cell and cell-based therapies

Written on May 26, 2021 on Phacilitate by Scott Jones, BBG Vice President of Scientific Affairs, and Anthony Trinh, QualTex Laboratories Senior Manager, Analytical Development, Cell Therapy Reference Laboratory

Cell and cell-based therapies are a novel and growing class of transformative therapies designed to address gaps in traditional treatment strategies. Regulatory approval for cell or cell-based products requires therapeutic developers to have a set of analytical tests to demonstrate safety, purity and potency. These tests must be validated and performed under current good manufacturing practice (cGMP) conditions.

In this whitepaper by BioBridge Global, Scott Jones, VP of Scientific Affairs at BioBridge Global, and Anthony Trinh, Senior Manager, Analytical Development Cell Therapy Reference Laboratory at QualTex Laboratories, go through 5 testing strategies that QualTex Laboratories use to help customers in the cell and cell-based therapy industry. 

Figure 1. Inhibition of PBMCs in response to MSCs

These strategies include:

  • Assay development process
  • Criticality of potency assays
  • Qualitative versus quantitative assays
  • Use of blood screening safety assays
  • Phase appropriate validations

The importance of client-lab collaboration

Written April 20, 2021 on Phacilitate by Ward Carter, Chief Operating Officer, QualTex Laboratories

A six-step roadmap to help you identify a laboratory testing partner

The demand for cell therapy product testing is increasing rapidly, as more researchers begin the process of transitioning their therapies into the commercialisation pipeline. As noted in a recent interview with Phacilitate, the Alliance for Regenerative Medicine reported that between 2015 and 2020 the number of regenerative medicine companies grew from 672 to 1001 and the number of clinical trials from 631 to 1078. All this growth means that there will continue to be a critical need for testing services to ensure safety, efficacy and performance of advanced therapies.

The availability of this type of specialised testing has not kept pace with the demand, so what we have repeatedly seen is that a GMP experienced laboratory focused on early and effective collaboration, plus smooth technology transfer, are critical success factors in helping researchers and therapeutic developers move their therapy toward clinical trials and, hopefully, commercial launch.

The challenge for many therapeutic developers has been the identification and selection of a laboratory for testing and manufacturing support. For this discussion, we are focusing on the laboratory selection process, providing a roadmap to help developers as they navigate the process. Finding the right laboratory can be complicated. To do an RFP, or to not do an RFP, that is the question…

This roadmap is designed to help narrow your search as you begin having conversations with the sales and support teams from the available laboratories. Creating an RFP (request for proposal) or RFI (request for information) can help you refine your needs and requirements and providing this information can also help the laboratory start with a better picture of your needs. Use the roadmap and your requirements document (RFP or RFI) to help identify the best laboratory to help you get your product to market or to help you maintain your product on the market.

Here is a brief roadmap to help researchers and companies that are moving into clinical trials, or even those who have a product in clinical trials, identify a laboratory testing partner that offers customisable solutions and provides a superior testing experience:

  1. Select a GMP experienced lab
  2. Choose your laboratory partner early
  3. Assess technology transfer capability and capacity
  4. Ask for examples of collaborative experience
  5. Intellectual property support
  6. Smaller may be better

1. Select a GMP experienced lab

Many testing providers have extensive lab testing experience, especially in the research setting. The key capability to investigate is how much experience a laboratory has with managing and testing samples that will be used for further manufacturing into advanced therapies, especially if the rare source material is human-based. Having access to GMP testing is a must-have to make the jump from investigation to commercial launch. Obtaining the required global accreditations takes time and considerable effort, which many organisations are not willing or able to do.

2. Choose your laboratory partner early 

Even during your research phase, it will be helpful, and in some cases critical, to identify a laboratory partner early in the process. Collaboration with your identified laboratory partner earlier in the development cycle can help to prepare your therapy for making the jump from research to clinical trials and hopefully following successful trials, to commercialisation.

3. Assess technology transfer capability and capacity

These are critical assessments for the transfer of the test methods that will be required to ‘verify’ your therapy has the right potency and therapeutic material in the product intended for trial use. The FDA has highlighted the impact of critical quality attributes (CQAs). Therapeutic developers need to understand their target indication and identify or develop a clear set of potency assays or functional assays early on to support their regulatory approval.

4. Ask for examples of collaboration experience

Collaboration is communication on steroids, so take the time it takes to assess how well a laboratory embraces collaboration vs telling you how they will ‘perform’ your testing. When we were awarded an MTEC contract in 2016, our focus was on building a strong collaboration between the four companies involved in the contract award and supporting the start-up of our new biomanufacturing facility. A direct benefit of that project was the addition of cellular therapy testing to QualTex’s list of capabilities. We bring the MTEC experience along with years of custom assay development and GMP testing for donated human materials to every customer interaction.

5. Intellectual property support

While different situations may call for different approaches, ‘what is yours is yours, and what ours is ours and what we develop together belongs to both’ is often the best approach we have found in dealing with IP. Most laboratories understand this, but it doesn’t hurt to do your due diligence. As there are no established standards for potency, it is essential that researchers define their own standards that may require multiple assays using different platforms. Potency testing is likely to involve new tests or new combinations of testing, so IP management will be very important. There are also going to be different assays for different time points through the development process. We recommend that you start with functional assays – characterisation and possibly potency – in animal models and then look at other assays at different times for safety, potency and/or characterisation.

6. Smaller may be better

Smaller laboratories are more likely to offer ‘boutique’ support for clinical developers and collaborate more effectively to arrive at an optimal solution to support your therapy development. But don’t forget about the first five things to consider as you evaluate your choices for a laboratory testing provider. As a testing partner, we offer both research-grade and GxP assays. Biotech companies will need both options, based on where they are in the process of developing and commercialising their product – from qualification to quality control and release testing.

Tissue team tops nation in femoral vein recovery

South Texas Blood & Tissue Center’s tissue recovery team has been named the nation’s top program for recovering cardio vascular tissue for CryoLife, an organization that provides tissue for cardiac and vascular surgeries.

Cryolife is recognizing our surgical team with a trophy in celebration of a 5.6% femoral vascular tissue error rate in 2020.

This is a big jump from 2019, when South Texas Blood & Tissue Center was ranked 32 out of 41 programs recovering femoral veins.

What changed?

Guillermo Robles, Tissue Recovery Manager, says having a dedicated suite at the Center For Life at University Hospital made a huge impact. 

“Recovering vascular tissue is a delicate process,” he said. “Having a state-of-the-art tissue recovery facility it provides our technicians the best environment for human tissue recovery.”

Along with giving the team appropriate lighting and space to work, there also are fewer distractions from nurses or hospital staff, who check in to see when the operating room will be available for the next surgical case.

Another benefit of the Center For Life recovery suite, which opened in February 2020, is that it reduces the need to travel.

“Previously, if we needed to go to Corpus Christi or Laredo for a recovery, it would be five hours of travel alone,” Robles said. “Tissue recovery often takes three to six hours. That’s a 12- to 16-hour shift for our technicians.”

The team took other steps to improve its recovery error rate. Heart, femoral veins and saphenous veins are delicate tissues that require precise recovery process. The team has dedicated many hours on training and improving their surgical techniques.

The Tissue Recovery Team’s work isn’t just life-enhancing, it’s lifesaving. Femoral veins are often used in heart surgeries for both adults and children.

“Those patients need these tissue grafts to live,” Robles said.

Ultimately, he said, it was the team’s dedication to the BioBridge Global mission of saving and enhancing lives that helped lead to their success.

Developing Risk-Based Testing Strategies for Advanced Therapies

Written April 15, 2021 by Michael Adeniya, Event Director, Phacilitate

An Interview with Emmanuel Casasola, Executive Director, Global Quality & Compliance, BioBridge Global

Although the advanced therapies industry is not new, no harmonised testing standards are currently available to align the industry. Some groups are actively working on building these standards and government agencies see the need to establish regulations to ensure patient safety; it is only a matter of time before standards are implemented.

Navigating the regulatory framework for biologics allows the testing strategies to be risk-based and phase-appropriate, which can help bridge the needs from research to cGMP compliance. It is exciting to support the industry with our expertise and new testing methods and this also fits well within our mission to save and enhance lives through the healing power of cells and tissue.

The testing question

Questions around required testing are asked frequently by our partners. What to test for? What is needed? How much testing is too much testing? All are very good questions and we aim to offer simple answers to the complex testing conundrum. One of the first things that need to be established is intended use: what is the therapy designed to do and how will it do it? This will facilitate the answers to some questions while also helping to identify key quality attributes.

Testing can typically be broken down into three categories: safety, purity and potency. First and foremost, the safety of the therapy is necessary. From the infectious disease testing of a donor to the final release testing of the product, all the assays need to be qualified. There are USP and EU Pharmacopeia methods that outline sterility, mycoplasma and endotoxin, which are commonly required tests, and these compendial methods are accepted by regulatory bodies. To ensure the methods are appropriate, the sample material should be qualified in a suitability study which would help identify any interfering substances that may give a questionable result. Even for a phase I clinical study, validating the suitability of safety assays is necessary to meet regulatory scrutiny.

The lack of standard purity and potency assays due to the level of innate complexity can be difficult to prove. A combination of a defined Analytical Target Profile (ATP) and the mechanism of action would establish the testing strategy required to ultimately lead to qualification of a therapy.

The USP supplement to <1224> “Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification” states:

“The ATP defines the objective of the test and quality requirements, including the expected level of confidence, for the reportable result that allows the correct conclusion to be drawn regarding the attributes of the material that is being measured. It is essential to reach a high degree of confidence that an analytical procedure will consistently generate reportable results that meet the ATP requirements under all condition of use and as the material progresses through the lifecycle.”

For example, if you are looking for a specific type of cell or exosome, your assay will need to identify those within a certain level of confidence in order to support the findings of a clinical study. A further example from the USP <1224> supplement:

“Assay: The procedure must be able to quantify [analyte] in [presence of X, Y, Z] over a range of A% to B% of the nominal concentration with an accuracy and uncertainty so that the reportable result falls within + C% of the true value with at least 90% probability determined with 95% confidence”

This example states you need to have an assay that can detect a specific characteristic (analyte) within a material (therapy) within a certain level of confidence (95%) with a high degree of repeatability (90%).

Based on whether the therapy is autologous or allogeneic, the purity assay for the donor or starting material is crucial in the manufacturing of the downstream product and the overall logistics. We need to fully understand how viable the cells are, i.e. what’s the time frame from donation to manufacturing to delivery to the patient? This turnaround can be very short and with very complex logistics, as such, testing speed is crucial and a discussion around what type of testing should be implemented is vital to generate results as quickly as possible and ensure the treatment reaches the patient on time? A laboratory partner needs to be nimble enough to provide such services and with unequivocal data.

Navigating regional regulatory requirements

Understanding all the critical quality attributes (CQAs) is essential and will need to be defined in the chemistry, manufacturing and control (CMC) document that is submitted to a regulatory body as a therapy progresses through clinical development to commercialisation. The ability to justify the assays used and how that information helps in determining the efficacy of a therapy will aid in the regulatory approval of your product.

While all regulatory bodies strive for the protection of patients and ensure the safety of the products being marketed within their country’s borders, there are some small nuances between them. Those nuances tend to relate back to the host countries, such as epidemiological and cultural differences.

For this reason, the PMDA (Japan) may have donor requirements that are a little different than the FDA or the EU. The EU is comprised of many nations and depending on where the clinical trial will be conducted will also need to engage with that host country’s agency. Likewise, each region may require different documentation at various phases so it will be critical to ensure all documentation requirements are fully understood.

QualTex Laboratories is available to help

Ultimately, while QualTex Laboratories has recently launched these new services, the experience and expertise are evident by our history of supporting companies. The collaborative spirit and mission-based mentality drives our employees to help deliver new therapies to patients. They are ready to take some of the pressure and questions which may overwhelm an organisation and test samples with high quality and reliable fashion.

COVID study in UK shows high levels of antibodies up to six months after infection

Results could have implications for immunity

Virtually everyone in a study in the United Kingdom who had COVID-19 still had antibodies to it in their systems three months after recovering, and almost nine in 10 had them after six months.

The research by UK Biobank included more than 20,000 people across the UK and was reported on the organization’s website.

“Although we cannot be certain how this relates to immunity, the results suggest that people may be protected against subsequent infection for at least six months following natural infection and, potentially, vaccination,” said Naomi Allen, UK Biobank Chief Scientist.

Six-month study

The study ran from May-December. A total of 20,200 participants provided monthly blood samples and data on their symptoms, along with reports on their adult children and grandchildren.

The most notable result was that 99% of participants who had COVID-19 still had antibodies in their systems after three months, and 88% had them after six months.

Younger people showed more antibodies

The study also found that while there was no difference in antibody levels by gender, the proportion of participants with detectable antibodies was higher in people under 30 and lowest in those over 70.

Variations in symptoms

The most common symptom was a loss of sense of taste and smell, reported by 43% of COVID-positive participants.

Twenty-four percent of COVID-positive participants were completely asymptomatic and 40% did not have one of the three major COVID-19 symptoms: fever, persistent dry cough or loss of sense of taste or smell.

The full report on the study is available on the BioBank UK website.

Recovered from COVID-19?

If you’ve recovered from COVID-19, you can help current South Texas patients fight by donating convalescent plasma. See if you qualify to donate plasma at SouthTexasBlood.org/COVID19.

If you can’t donate plasma, you can help by donating blood to help fight the blood shortage caused by the pandemic.

Testing Strategies and Custom Assay Development for Cell and Cell-based Therapies

Written Jan. 6, 2021 by Michael Adeniya, Event Director, Phacilitate

An Interview with Ward Carter, Chief Operating Officer, QualTex Laboratories

As the cell therapy industry grows and matures, demand for testing has soared. Is testing a bottleneck in getting therapies to market?

It can be, for several reasons. The number of cell therapy development programs has increased dramatically in recent years, and as they progress toward commercialization, demand for testing has grown exponentially. At the same time, only a few laboratories provide testing services for these types of therapeutics.
Increasing capacity and obtaining the required global accreditations takes time and considerable effort, which many organizations are not willing to do, or it doesn’t fit with their growth plans.
Just to give you an example, the Alliance for Regenerative Medicine reported that between 2015 and 2020, the number of regenerative medicine companies grew from 672 to 1,001, and the number of clinical trials went from 631 to 1,078. All this growth means there is a critical need for more testing to ensure safety and performance of these potential new therapies.

Fully automated testing laboratory

How does testing fit in the overall development and commercialization of cell therapies?

Every therapeutic development process begins with qualification of donor material. Depending on the nature of the product, whether it’s a 1:1 product (autologous or allogeneic) or 1:many (allogeneic), the number and complexity of needed tests changes. It’s important to understand that range up front.
Recent feedback from the FDA has highlighted the impact of Critical Quality Attributes (CQAs). Therapeutic developers need to understand their target indication and identify or develop a clear set of potency assays or functional assays early on to support their regulatory approval. The FDA’s recent position regarding a therapy showing clinical benefit, but with insufficient CQAs, makes it clear that moving forward without this understanding is risky.
Researchers also need to make sure a testing laboratory has a process for tech transfer of assays if required, at the pre-clinical, clinical and commercial phases.
In the case of autologous therapies, turnaround times are tight, so there isn’t much available for backup samples. And while tests tend to focus more on whether the cell manipulation worked, the key is making sure the sample passes more standard donor safety requirements. This is especially true in the case of infectious diseases.
And how does testing fit in the overall supply chain?
Testing is an integral part of every step of therapeutic development, and it takes a full-service laboratory with a robust infrastructure to handle receiving and tracking a wide range of sample types. That laboratory also needs to be able to develop custom assays.
In addition, reporting requirements for cell therapies can vary, and the timing of those reports can affect production. It’s critical to the process that testing providers and therapeutic developers stay in regular communications about needs and results.
Given the complexity of the supply chain and the number of stakeholders, it is really important for therapeutic developers to be working with their testing laboratory in tandem with all other partners to establish their testing program, including custom assays.
At what point should biotech organizations be looking at custom assay development?
If they want to be successful, they need to focus on custom assays early in the process. There are Critical Quality Attributes that are essential for approvals throughout the development process, and standard characterization assays often are not going to be sufficient. Critical 
Because there are no established standards for potency, it’s essential that researchers define their own standards that may require multiple assays using different platforms. There also are going to be different assays for different time points through the development process. They could start with functional assays – characterization and possibly potency – in animal models, and then look at other assays at different times, for safety, potency and/or characterization.
There are safety assays that will be required before a clinical trial can get underway. Others will need to be converted from in-vivo models into those that can be used in clinical phases of trials.
As a testing partner, we offer both research grade and GxP assays. Biotech companies will need both options, based on where they are in the process of developing and commercializing their product – from qualification to quality control and release testing.

QualTex and BioBridge Global headquarters in San Antonio, Texas

Can you tell us more about BioBridge Global’s journey into cell therapy testing?
BioBridge Global began as a community blood bank in 1974, and in the last 45-plus years, the number and complexity of tests required by the FDA has grown dramatically. We have been performing those tests in-house for many years. Gradually we expanded into testing donations from other blood centers, and then to other types of donor screening, including plasma and human tissue, as well as custom assay development. Our footprint has become global, with accreditations in the United States, Canada, the European Union, Asia and Australia.
In 2016, BioBridge Global was awarded an MTEC contract to develop manufacturing capabilities for cellular products, as well as stand-up capabilities for cell therapy testing. At that time, we decided to invest in a biomanufacturing facility and in the testing required for it. We’re continuing to build a portfolio of cellular therapy assays to support therapeutic developers in their clinical and commercial efforts.