When Every Hour Counts: How Cryoport Systems Rapidly Mobilized to Protect INmune Bio’s Critical Clinical Materials
Biopharmaceutical development, especially for advanced cell and gene therapies (CGTs), is a complicated road where innovation alone is only part of the story. Behind every promising therapeutic candidate is an often invisible, but absolutely critical, infrastructure of logistics, BioServices, and temperature-controlled supply chain systems that ensure drug products arrive intact, on time, and within stringent regulatory controls.
For INmune Bio Inc., a clinical-stage biotechnology company developing novel biotherapeutics, that infrastructure was put to the ultimate test when a sudden biostorage site closure threatened to derail a pivotal clinical trial.
When you have a strong network of support, you can lean on established partners like Cryoport Systems, which is exactly what happened in this case. Cryoport Systems stepped in, mobilizing people, systems, and global expertise in under 24 hours, to not only save a critical drug product, but to reinforce a strategic, long-term partnership for international clinical success.
INKmune™ and the Fight Against Prostate Cancer
Prostate cancer is the second most common cancer in men around the world, and when it progresses to metastatic castrate-resistant prostate cancer (mCRPC), treatment options become limited. INmune Bio’s INKmune™ platform offers a novel approach by priming a patient’s own natural killer (NK) cells to recognize and kill resistant tumor cells.
This innovative therapy is currently in clinical trials, with the CaRe Prostate (a Phase I/II open label, dose escalation and expansion study) trial being conducted in the United States. INmune Bio relies on a complex, multi-site, multi-national supply chain to ensure that the manufactured drug product, a temperature-sensitive and highly regulated cell therapy, reaches patients safely.
But even the most carefully constructed plans can be upended by forces outside the lab.
The Unthinkable Happens: A Storage Site Closure
On what was supposed to be a rare vacation for Ben Weil, COO at INmune Bio International, the company received alarming news that the biostorage facility they were working with in Ohio, where multiple batches of clinical trial material were stored, had abruptly ceased trading.
“This was my first holiday in years,” reflected Weil, “and suddenly everything went wrong. Our storage site was suddenly closing, and we were faced with a situation we never imagined could happen.”
The manufactured INKmune™ drug product stored inside was suddenly, on a Friday night, at risk of being lost or compromised.
The stakes couldn’t have been higher. Without the stored material, ongoing clinical trials could be delayed by months. Manufacturing replacement batches would take weeks and then would require the subsequent, time-consuming regulatory clearances and requalification. Patients enrolled in trials could face treatment interruptions, with devastating possible consequences for both patient health and clinical timelines.
More than a straightforward logistics problem, this was a clinical and commercial threat.
INmune Bio Turned to Cryoport Systems
Fortunately, this crisis didn’t unfold in isolation. INmune Bio had already been working with Cryoport Systems for over a year, leveraging the company’s Stevenage, UK Global Supply Chain Hub to support international shipments of clinical materials between manufacturing sites, biostorage facilities, and trial centers.
Cryoport Systems’ ability to coordinate across continents and manage complex international logistics and regulatory compliance had already proven invaluable to INmune Bio’s global operations. So when the call came in, the INmune Bio team knew exactly who to reach out to.
“There was no hesitation,” shared Mark Lowdell, Ph.D. and CSO at INmune Bio. “We knew Cryoport Systems had the infrastructure, the people, and the expertise to jump on this immediately, and Ben’s senior colleague, Jorge Salazar, stepped up and took control.”
Behind the Scenes: Mobilizing a Global Team
Cryoport Systems’ emergency response was anything but ad hoc. Within hours, a cross-functional team was activated, spanning the company’s entire global network with coordination between the Morris Plains, New Jersey site and the Stevenage, UK site as well as a wide range of support from other locations and team members across legal, BioServices and biostorage, logistics and operations, business development, quality, and other departments.
This comprehensive team was able to accelerate Master Service Agreements (MSAs), establish Standard Operating Procedures (SOPs), and ensure all paperwork was completed at record speed to authorize the immediate transition. Cryoport Systems’ local teams in Morris Plains prepared to receive the rescued materials, ensuring storage conditions, equipment availability, and quality controls were aligned.
Because Cryoport Systems operates a wholly-owned fleet of shipping systems, the logistics team was able to immediately dispatch six shipping systems to retrieve materials from the Ohio facility, coordinating routes while maintaining strict temperature and handling protocols. Using the Cryoportal® logistics management system alongside integrated Smartpak™ condition monitoring system, both Cryoport Systems and INmune Bio teams maintained full visibility into shipment status, location, and environmental conditions throughout the entire journey for continued confidence that the materials were maintained under optimal conditions with no temperature excursions or other risk factors.
“Even with the time zone differences, everything was smooth,” reflected Weil. “We were able to communicate clearly, make decisions fast, and move forward without delay. It was the definition of teamwork.”
Six High-Stakes Shipments Rescued in One Day
Under normal circumstances, coordinating six simultaneous, high-value biological shipments would take weeks of planning. Cryoport Systems executed the rescue operation in less than 24 hours.
Even when the initial pickup address was incorrect, a problem that might derail another logistics provider, Cryoport Systems rerouted and recovered the materials without missing the tight timeline.
For INmune Bio, this was more than just a logistical success, it was a lifeline for their clinical program.
Beyond Technology, a Human Story
While Cryoport Systems’ technologies were key enablers, both companies emphasized that the real differentiator was the people behind the systems.
“It’s the people that made the biggest difference,” said Lowdell. “The way Cryoport Systems’ teams across departments came together, the clear communication, the accountability; that’s what turned a potential disaster into a success story.”
The experience highlighted an important truth for biopharma developers: in times of crisis, what matters most is not just the service, but the relationship.
Building a Long-Term, Global Partnership
Today, INmune Bio’s clinical materials are securely housed with strategic support that spans continents. Weekly check-in calls, a dedicated point of contact, and proactive planning have replaced the firefighting of the past. Together, the two companies are building a robust operational foundation that will support not only the current clinical trials, but future scale-up and commercialization efforts.
For INmune Bio, the experience has reshaped how they evaluate supply chain partners.
“It’s not a supply chain, it’s a value chain. It’s not a transactional business, it’s a strategic relationship. We’re not looking for vendors, we’re looking for strategic partners who can flex with us as we grow. We build so much value by going through these things together, it’s more than just supporting these shipments. Other companies can transport from A to Z, what we look for is a partner that goes above and beyond,” noted Weil. “With Cryoport Systems, we have that confidence.”
Looking Ahead to Innovation, Collaboration, and Enabling Outcomes
As INmune Bio continues to advance the INKmune™ program, their partnership with Cryoport Systems is evolving to meet new challenges. Building on this collaboration, INmune Bio plan to utilize Cryoport Systems as a trusted service provider for their CORDStrom™ platform as it moves towards BLA submission. From supporting additional trial sites to preparing for potential regulatory approvals, the companies are working hand-in-hand to ensure that innovation translates into patient impact.
For Cryoport Systems, the experience reinforces its core mission of Enabling the Outcome™. By combining world-class logistics, advanced BioServices and biostorage, and a culture that is committed to customer success, Cryoport Systems helps biopharma companies navigate complexity, reduce risk, and bring life-changing therapies to market.
A Blueprint for Biopharma Success
In a situation where every shipment carries the weight of years of research, millions of dollars, and the hopes of patients worldwide, there isn’t room for uncertainty.
The INmune Bio story is a powerful reminder that supply chain partnerships offer strategic enablement of innovation, clinical progress, and ultimately, patient outcomes.
When you choose a partner like Cryoport Systems, you’re doing more than simply moving materials, you’re protecting the future of medicine.
