Day: August 12, 2025

Blueprint for Breakthroughs is a LinkedIn newsletter published by Adrienne B. Mendoza, MHA, SVP BioBridge Global and Chief Operating Officer (COO), BBG Advanced Therapies

Originally published on LinkedIn on July 22, 2025

From Lifesaving to Life-Changing: The Blood Bank and the Future of Advanced Therapies

The blood bank have long stood as quiet guardians of public health, responding to trauma, supporting surgery, and helping patients live longer, healthier lives through the generosity of others. They’ve built deep relationships with their communities, earned public trust, and developed operational excellence that few institutions in healthcare can match.

But as medicine moves steadily toward advanced, individualized therapies, blood banks are showing that their role doesn’t end with transfusion of traditional blood components. In many ways, they are perfectly positioned to support what comes next.

Witnessing the Birth of a New, Adapted Drug Delivery Model

Advanced therapies, also called cell and gene therapies, such as CAR T-cell therapies have challenged everything we’ve traditionally known about how drugs are delivered.

They’re not manufactured in bulk and shipped to pharmacies. They don’t sit on shelves waiting to be administered. These therapies are made from living cells, often from the patient or a uniquely qualified donor, and must be collected, transported, processed, and sometimes returned for infusion. It’s a closed-loop, time-sensitive, chain-of-identity-driven process.

What we’re witnessing is the emergence of a new, adapted drug delivery model – one that requires regionalization, precision logistics, and deep coordination across clinical, manufacturing, and community systems.

This is exactly where blood centers excel. With decades of experience in safely moving human-derived materials, blood banks are well-positioned to:

• Serve as regional collection hubs for both patient and donor cells
• Maintain cryogenic storage and transport readiness
• Offer integrated donor qualification and testing under GMP conditions
• Support clinical trials or commercial therapy delivery by embedding into community care infrastructure

As more therapies move toward distributed manufacturing models or close-to-care cell processing, the value of regional partners with strong community engagement, public trust, regulatory oversight, and real-time logistics capabilities cannot be overstated.

Blood centers are capable of adapting to this shift, and in the case of some cell therapy organizations rooted in blood banking, like BBG Advanced Therapies, they’re helping define it.

Blood Banks – A Living, National Network

What many outside the field may not realize is that blood banks are already a national network, one of the most geographically distributed, logistically-connected, and community access-enabled infrastructures in healthcare.

This network is built for coordination:

• Local community presence, national interoperability
• Comprehensive donor databases and quality standards
• Proven chain-of-custody and biovigilance systems
• Regional hubs that can support decentralized trial and manufacturing models

This matters because cell and gene therapies don’t move like pills. They rely on living cells with starting materials that must be sourced, qualified, transported, and in many cases, returned to the patient. Every handoff matters. Every mile matters and every second counts. And this is where blood banks shine.

Blood centers can, and are evolving to:

• Recruit and screen healthy donors for starting cells and tissues
• Collect patient and donor cells through leukapheresis
• Support the National Marrow Donor Program, cord blood banks, and transplant networks
• Provide validated infectious disease, sterility, and potency testing
• Recover tissue that can serve as source material for regenerative medicine
• Manufacture early- and late-stage cell and tissue-based products in GMP cleanroom environments
• Bring cell collection services (leukapheresis) to trial and commercial cell therapy infusion sites

One Example – A Community Blood Bank Becomes a Bridge for Therapies Tomorrow

I’ve had the privilege of seeing this shift firsthand through my work at South Texas Blood & Tissue and BioBridge Global. What we’ve built is a reflection of what’s possible when a blood center evolves with purpose, having expanded the organizations scope to include:

• Donor and patient cell collection, including peripheral blood mononuclear cells, cord blood, and tissues
• Cell therapy testing for sterility, identity, and potency
• Support for the National Marrow Donor Program, ensuring equitable access to transplant therapies
• Tissue recovery that contributes not only to transplant but also to the development of regenerative medicine
• Cleanroom manufacturing capabilities to support early-phase through commercial-scale production
• Mobile leukapheresis teams that bring access closer to home for both patients and healthy donors

These efforts are grounded in decades of operational expertise and public service, and they demonstrate that the blood bank model is not static. It’s dynamic, resilient, and increasingly essential in today’s therapeutic landscape.

Where other sectors are building from scratch, blood centers bring something rare: infrastructure, credibility, and human connection.

Cells Are in Our Blood – Literally and Philosophically

Let’s not forget something simple, but profound:

Every cell therapy begins with a cell. And every cell comes from blood or tissue.

Long before the term “personalized medicine” became popular, blood centers were quietly delivering it – one donor, one patient, one lifesaving connection at a time.

A unit of blood. A cord blood donation. A marrow match. Each one unique. Each one irreplaceable.

The future of medicine may look different, but the heartbeat remains the same.

We are not just blood banks. We are part of a deeper lineage of care, one that continues to evolve to meet the needs of tomorrow and as we enter this next chapter, the role of blood banks in advanced therapies deserves broader recognition, as essential partners in shaping what access, equity, and scale will look like in the future of medicine.

Blood centers are uniquely positioned to bridge the clinical and the community, the research and the reality, the science and the system. We understand the logistics of healing, the urgency of patient need, and the power of showing up locally – at scale.

If you’re exploring how to bring advanced therapies closer to the people who need them, I’d love to connect, so feel free to reach out to me at Adrienne.Mendoza@BBGAT.org.

Blueprint for Breakthroughs is a LinkedIn newsletter published by Adrienne B. Mendoza, MHA, SVP BioBridge Global and Chief Operating Officer (COO), BBG Advanced Therapies

Originally published on LinkedIn on August 12, 2025

Most of us didn’t choose to work in cell and gene therapy because it was easy. We chose it because somewhere, right now, a patient is waiting – a parent hoping to see their child grow up, a young adult wanting more than borrowed time, an older patient wishing for one more healthy year with their family. This is the heart of our work: turning science into survival, moving breakthroughs from bench to bedside as quickly, safely, and reliably as possible. In my last article, we explored the critical role of potency assays in ensuring advanced therapies deliver on their promise. Today, I want to go further, because when potency testing gaps trigger regulatory delays, the journey slows, and every single day matters.

Two clocks start ticking at once: the patient clock and the sponsor clock. For patients, each lost day can mean disease progression or the loss of eligibility for treatment. For sponsors, each lost month can mean millions in unrealized revenue and a shrinking window to make an impact.

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Potency: The Cornerstone of Efficacy – and a Hidden Risk

Potency is not simply a measure of “strength”; it is the clinical fingerprint of a therapy’s intended biological effect. For advanced therapies, potency directly impacts dose accuracy, regulatory approval, and commercial scalability.

Yet, despite the industry’s advances in sourcing and processing starting materials, potency testing too often remains an afterthought—becoming a silent bottleneck that delays development and obstructs market entry.

The scale of the problem is clear: according to a review of Advanced Therapy Medicinal Product (ATMP) applications at the European Medicines Agency, nearly 50% encountered potency-related issues during regulatory assessment, often resulting in significant delays. Former FDA CBER Director Peter Marks has similarly noted that potency-related problems are among the most common reasons for delayed approvals in cell and gene therapies. (Alliance for Regenerative Medicine, 2023, Solvias, 2024)

“Potency-related problems have been among the most common reasons for delayed approvals in the field” – Peter Marks, M.D., Ph.D.)

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The Patient Clock Is Always Ticking

In advanced therapies, the patient clock is relentless. For individuals facing aggressive diseases like relapsed large B-cell lymphoma, the waiting period is not neutral—it’s dangerous. Clinical data suggest that 20–25% of patients may lose performance status each month without effective therapy, potentially disqualifying them from receiving CAR-T or other advanced treatments (NCCN Guidelines, 2024).

The patient-day loss metric helps make the scale of harm visible. In a high-yield allogeneic CAR-T scenario, where one batch may treat 100 patients, a one-month potency-related delay equals 3,000 patient-days without therapy, more than eight years of cumulative lost treatment time across the waiting population.

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The Financial Clock Is Ticking, Too

Potency failures aren’t just a clinical problem, they’re a financial one. Each month of delay for a high-value therapy can cost $5–$15 million in lost revenue (Precedence Research, 2024). This doesn’t include the added costs of prolonged manufacturing holds, supply chain disruptions, or the opportunity cost of missed patient enrollment in clinical trials.

For sponsors, every month saved in regulatory review is a month of additional patient treatments and realized revenue. Potency readiness is, therefore, not just a regulatory compliance measure, it’s a risk mitigation strategy and a competitive advantage.

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Bridging the Two Clocks

Everyone in this field shares a common mission: to see transformative therapies reach patients who need them, on time, every time. But potency gaps put that mission at risk, slowing both the delivery of care and the realization of a therapy’s full potential in the market. The tragedy is that these delays are often avoidable.

The path forward is clear:

• Integrate potency strategy from day one—design assays around the therapy’s mechanism of action so they measure what truly matters for efficacy.
• Validate under GMP conditions early—don’t wait for late-stage development to stress-test your assay in the same conditions you’ll face at scale.
• Engage regulators proactively—align on expectations before you submit, reducing the risk of rework or rejection.

When potency testing is embedded as a core capability rather than a downstream checkbox, we bridge the patient clock and the sponsor clock. We protect timelines, safeguard budgets, and, most importantly, keep our promise to the people who are waiting.

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Here to Help You – And Through You, The Patients

If you’re developing an advanced therapy, potency planning is mission-critical. The patients you serve can’t afford preventable delays, and neither can your program. At BBG Advanced Therapies, we partner with sponsors to design potency strategies that stand up to regulatory scrutiny, scale with manufacturing, and protect both timelines and patient access.

Every day saved in potency readiness is a day gained for a patient’s future. Let’s make sure no one waits longer than necessary, and no therapy loses momentum to save a life.

📩 Connect with us at bbgat.org or through our Contact Us page. Together, we can bridge the gap between breakthrough science and the patients who need it.

References

Alliance for Regenerative Medicine. (2023, March 22). Addressing potency assay-related development delays for cell and gene therapies [White paper]. https://alliancerm.org/wp-content/uploads/2023/03/Addressing-potency-assay-related-development-days-for-cell-and-gene-therapies-March-22.pdf

National Comprehensive Cancer Network. (2024). B-cell lymphomas (Version 2.2024). NCCN Clinical Practice Guidelines in Oncology. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf

PDA. (2024). Continuing the conversation for better ATMP development. Parenteral Drug Association. https://www.pda.org/pda-letter-portal/home/full-article/continuing-the-conversation-for-better-atmp-development

Precedence Research. (2024). Advanced therapy medicinal products market size, share, growth trends 2024 to 2034. https://www.precedenceresearch.com/advanced-therapy-medicinal-products-market

Solvias. (2024). The potency puzzle: Overcoming potency assay challenges for ATMPs [White paper]. https://www.solvias.com/wp-content/uploads/2024/08/White-Paper-The-Potency-Puzzle.pdf