2025 Year in Review: Turning Standards and Resilience into Outcomes
If you work within the advanced therapy ecosystem, you already know the story of 2025 from an industry standpoint, where science continued accelerating while funding and commercialization hinged on whether the supporting systems could keep up. For Cryoport Systems, that reality was a catalyst. This year, we raised the bar yet again and demonstrated how having the right strategic partnership behind your end-to-end supply chain can turn logistics into leverage, can transform compliance into confidence, and can spin scale into speed.
We began the year by challenging the industry to expect more from its supply chains, and then spent the twelve months of 2025 delivering on that challenge. From standardizing starting materials to opening new infrastructure that compresses timelines, every move we made this year was designed to remove friction from the critical intersection where regulatory certainty meets patient access (with simultaneous junctures into investor confidence and global scalability).
Consider what’s changed in practice.
We advanced the case for standardization where it has the greatest downstream impact, right at the start, with the collection and handling of starting materials collected via apheresis. Through our IntegriCell® cryopreservation services and our proprietary Automated Closed Process (ACP) approach that standardizes the handling and cryopreservation of leukapheresis-derived starting materials, our teams brought fresh data to ISCT demonstrating that a functionally closed, automated approach can produce consistent and high-quality leukapheresis starting material for both autologous and allogenic programs. This approach not only standardizes handling, but quickly becomes a manufacturing advantage by reducing variability in starting materials while extending the manufacturability of these highly sensitive and often irreplaceable cellular materials. This translates into fewer surprises downstream, more predictable release testing, optimized scheduling and manufacturing windows, and a clearer, more well-defined and standardized path to scale. This was reiterated and emphasized in a panel discussion this fall, where experts from across the CGT ecosystem discussed whether standardization is the bottleneck or breakthrough for cell and gene therapy. Sponsors and industry experts alike told us the same thing throughout the year, highlighting that when the quality of your input is controlled, the rest of the system naturally follows.
We matched that technical progress with operational integration. Going into 2025, many developers were juggling siloed vendors and fragmented vendors, complicated by duplicated and numerous handoffs. They quickly discovered how much time is saved and risk evaporates when their disparate links in the supply chain are brought together within a single vendor partnership and under one roof. Our integrated supply chain platform approach combined key services like cryopreservation, biostorage, packaging and labeling, lane qualification, and logistics orchestration with continuous monitoring, so that programs moved faster and with fewer variables. For CDMOs, that integration meant a supply chain stitched directly into their workflows. For CROs, it created timelines that survive pressure and earn sponsor trust. For sponsors, it meant a partner that aligns to the way they build and scale therapies rather than requiring them to manage the glue between a patchwork of providers. For everyone, that meant building scalability while minimizing capital expenditures to maintain flexibility in an uncertain funding environment.
Resilience, the theme that quietly defined the year, showed up in the moments that don’t make glossy headlines. When a client’s third-party biostorage site closed without warning, our global teams mobilized within hours to protect INmune Bio’s critical drug product and keep a pivotal trial on track. When geopolitical conditions disrupted air travel and clinic operations, our processes for reproductive shipments held strong, because contingency is only useful if it’s already planned for. And when organizations confronted the overlooked risks in first and last mile movements, Cryoshuttle® proved why the shortest distances can be the most consequential. Reinforced Chain of Compliance®, combined with purpose-built local pickup and delivery and continuous monitoring, closes gaps that often sit outside of global carrier lanes, yet determine whether material arrives within specification.
Europe saw the clearest example of what happens when you combine integration with proximity. In October, we opened our 55,000 sq. ft. Global Supply Chain Center in Louvres, France, strategically located just outside of Paris and minutes from Charles de Gaulle Airport, giving sponsors in the region direct access to end-to-end supply chain support where they operate. The result is practical, with faster cycle times, fewer cross-border complexities, and a single campus that connects key services under one roof with phased additions of BioServices and biostorage expanding capabilities over time. Paired with our Stevenage, U.K. logistics hub and Villers-le-Bouillet, Belgium cryopreservation center, both of which opened last year, and existing logistics center in Amsterdam, The Netherlands and BioServices centers in Pont-du-Château and Clermont-Ferrand, France, our global footprint is built for how advanced therapy medicinal product (ATMP) developers actually scale, supporting clinical programs that become commercial supply without re-architecting the entire network.
Standards matter as much as speed. Throughout the year, we continued urging the industry to treat compliance as a design principle, not a checkbox. In November, that message crystallized with a milestone that raises the bar for everyone when Cryoport Systems became the first global supply chain solutions provider to achieve ISO 21973 certification. We were involved in drafting the standard and have long operated against the rigor that the standard codifies, including validated cleaning and decontamination through our Veri-Clean® process, full traceability through Chain of Compliance, and continuous monitoring and data centricity with our Cryoportal®, but formal certification sends a signal to regulators and sponsors alike that the system you’re trusting is proven against the toughest requirements. That matters. Whether you’re coordinating qualified person (QP) release or demonstrating to auditors that your data and documentation match the journey your material actually took, leveraging the industry’s most stringent quality and compliance standards from the earliest stages of development streamlines scalability downstream.
Animal Health and Reproductive Medicine also moved forward in ways that are often under-reported but essential. Delivering more than five billion doses of biotherapeutics in support of animal health, for example, is only possible when quality assurance is built into every mile. From cold chain controls to documentation and continuous monitoring, every step is designed to withstand the realities of field logistics. In Reproductive Medicine, the conversation among fertility clinics leaned into cryogovernance over cryomanagement, extending risk frameworks beyond the lab and into storage policies, transfer and shipping protocols, and cross-border movement as fertility care increasingly crosses geographical lines. The through-line is the same across markets, as systems win when they protect trust (not just temperature).
Recognition followed performance, and while awards are never the goal, they do tell partners what the market already knows. Early momentum at Advanced Therapies Week gave way to significant wins later in the year, like the CPHI Pharma Award for Supply Chain Excellence and BioServices Innovation of the Year for the Safepak® Soft System 1800, technology designed specifically to reduce risk for fragile, high-value cryogenic payloads while simplifying workflows. The industry also voted with confidence, naming Cryoport Systems Best Cell & Gene Supplier – Cell Processing Systems at APCGTEA and shortlisting us across four categories for the Asia-Pacific Biopharma Excellence Awards (with results to be announced in Q1 of next year). The common denominator in every recognition this year goes back to impact. We’re intentionally creating systems that remove bottlenecks and withstand pressure, translating directly into patient outcomes.
If there’s a single idea to carry into 2026, it’s that integrated, standardized supply chains that are resilient are the enabling platform for everything else that follows. The organizations that will win next year are the ones that refuse to accept fragmentation as a cost of doing business. They will insist on qualified systems from the start, will adopt standardized cryopreservation to control variability, will bring infrastructure closer to markets to compress timelines and expand patient access, and will select partners who design for continuous monitoring and regulator-ready standardization and traceability.
That’s where Cryoport Systems will continue to lead. The grand opening in Louvres, France, for example, was more than a simple ribbon-cutting ceremony… it was a continued commitment to proximity and scale. The work we shared through our ISO 21973 certification was more than a press release… it was a promise to keep raising the bar for safety, integrity, and auditability. And the performance we delivered across cell and gene therapy, reproductive medicine, and animal health was more than a set of blog posts and case studies… it was a record of outcomes achieved when a future-proofed supply chain becomes a strategic advantage.
To everyone who trusted us this year, including our sponsors, CDMOs, CROs, clinics, and developers who rely on us for their supply chains, thank you. Your programs are undoubtedly as advanced as your therapeutics, and we collectively built systems that delivered. 2025 was a year with its challenges, and together we proved that when infrastructure and innovation align, advanced therapies don’t just move… they scale. Thank you for the continued trust you put in Cryoport Systems as we Enable the Outcome™ for your programs and the patients you serve. Cheers to 2026 as we continue to push that standard even higher.
