09/10/2025 | News release | Distributed by Public on 09/10/2025 13:29
Cell and gene therapy (CGT) programs are among the most complex and sensitive operations in the life sciences. From cryopreservation and biostorage to logistics and regulatory compliance, every step in the supply chain can influence product integrity, clinical timelines, and the scalability of the program. For program heads as well as clinical and technical operations teams, the challenge becomes bigger than merely moving materials. It quickly becomes a challenge of scaling efficiently while maintaining compliance and supporting growth across a global network.
At Cryoport Systems, our Global Supply Chain Centers (GSCCs) are designed to address these challenges head-on. Facilities such as our Houston and Morris Plains GSCCs, with additional centers coming soon in Paris, France and Santa Ana, California, bring together multiple supply chain services like IntegriCell® cryopreservation services, BioServices and biostorage, shipping systems, logistics support, and consulting and advisory services all under one roof. By consolidating these critical, end-to-end capabilities, programs experience fewer handoffs and streamlined workflows within a cohesive platform that enables programs to scale smarter.
Traditionally, CGT programs rely on multiple vendors to manage storage, shipments, and other specialized services. While each partner may do a good job within their narrow scope, the coordination required across multiple providers introduces complexity and creates potential points of failure. Every additional handoff is a risk and a source of potential delay or disruption that can impact program timelines and budgets.
Cryoport Systems' fully integrated, end-to-end supply chain platform approach eliminates these friction points. By bringing together logistics, cryopreservation, BioServices and biostorage, and consulting and advisory services within a single vendor relationship, programs gain a level of operational consistency that's difficult to achieve with a fragmented network of vendors. These efficiencies are further compounded by co-locating services within a single facility, where logistics operations ensure that materials and products move securely and within full Chain of Compliance®. BioServices teams manage master, working, and research cell banks, providing scalable storage solutions that adapt to program growth. Cryopreservation with IntegriCell™ services standardizes protocols to maintain cell viability, reduce variability, and enable just-in-time delivery to manufacturing or clinical sites. Consulting and advisory support complements these operational capabilities, providing guidance on shipping system and packaging performance qualification, shipping lane validation, and shipping risk assessments to support your regulatory filings.
The integration of these services allows programs to focus on execution rather than coordination. Teams no longer spend valuable time managing multiple vendors or reconciling disparate processes. Instead, they can trust that every step from cryopreservation to storage to shipment and compliance is managed within a single, orchestrated system.
Scaling a CGT program goes deeper than producing more doses, it requires careful management of complexity across global operations while maintaining quality and regulatory compliance. Our GSCCs, incorporated into our full global footprint that also includes logistics facilities, BioServices centers, and IntegriCell cryopreservation facilities, provide the flexibility and operational efficiency that programs need to expand or contract capacity without overcommitting capital. Pre-qualified shipping systems, integrated cryopreservation workflows, and just-in-time material delivery keep programs moving quickly while minimizing risk.
Standardized processes across our entire global footprint ensure operational consistency, reducing variability that can complicate clinical trials or manufacturing workflows. For clinical operations, this translates into fewer bottlenecks and a smoother transition from early-phase trials to commercial launch with customized support at every stage in between. Technical operations teams benefit from a predictable, repeatable process that allows for scale across sites and regions without compromising quality.
CGT programs operate on a global scale, but speed and precision are local imperatives. In addition to our global network of logistics, BioServices, and IntegriCell cryopreservation facilities, our GSCCs are strategically located to combine worldwide reach with local agility. Sensitive materials can move across continents while maintaining Chain of Compliance integrity, and regional hubs allow for faster clinical trial support and local manufacturing alignment.
This global network reduces transit times and mitigates risks associated with multiple handoffs or long-distance shipping between vendor networks. Programs can rely on consistent operational standards, regardless of whether a shipment is moving from a U.S.-based manufacturing site to a European clinical trial center or between regional production facilities. The result is a logistics ecosystem that supports growth while maintaining product integrity and regulatory compliance from start to finish.
Managing multiple vendors, disparate processes, and unpredictable handoffs introduces risks that can be difficult to quantify but that are costly to CGT programs nonetheless. Delays, variability, and inconsistent protocols can all disrupt timelines and impact regulatory filings and product quality. By consolidating these functions within a single vendor relationship (and, in the case of our GSCCs, within a single facility), Cryoport Systems eliminates many of these hidden risks.
Programs benefit from fewer touchpoints coupled with predictable and consistent workflows, as well as centralized documentation to support compliance and regulatory reporting. The integrated model reduces operational friction and allows teams to focus on advancing therapies rather than managing logistics and vendor handoffs. At the end of the day, our GSCCs convert logistical complexity into a strategic advantage.
Technology and infrastructure alone do not ensure success, however. At Cryoport Systems, we combine these capabilities with deep industry expertise. Our teams understand the science behind CGTs, the regulatory frameworks that govern biologics, and the operational urgency that define clinical and commercial programs. This expertise ensures that every step of the supply chain is implemented with precision and reliability.
From consulting on shipping lane qualifications to supporting program growth through just-in-time delivery and scalable biostorage, we integrate knowledge with technology to provide a supply chain platform that programs can trust. The result is not only more efficient operations, but a tangible reduction in the operational and compliance risks that can slow program progression.
When it comes to personalized medicine like CGT, timing is everything. A single delay can ripple across clinical schedules or disrupt manufacturing. That's why Cryoport Systems has built the industry's largest wholly-owned fleet of custom-engineered shipping systems, ready to move at the pace that CGT programs demand.
Our infrastructure is designed to deliver speed without compromise. Turnaround is often completed in under 24 hours, ensuring programs can respond to shifting timelines without losing momentum. Holiday and weekend availability can be arranged on request, providing a level of flexibility that keeps programs moving even when others stand still. And because our shipping systems are wholly owned, not dependent on third-party leasing or limited inventories, our clients never face unexpected shortages or bottlenecks.
The result is predictable, reliable capacity, adhering to the industry's most robust compliance standards, at every stage of development. Whether scaling a new trial across regions or managing commercial distribution, Cryoport Systems has the purpose-built infrastructure to eliminate unnecessary delays, ensuring therapies continue moving forward on time, every time.
By leveraging Cryoport Systems' Global Supply Chain Centers, programs gain consolidated, end-to-end supply chain capabilities in a single location. This integrated approach allows programs to scale efficiently without sacrificing compliance or quality. Flexible capacity, operational consistency, and a global network of facilities enable teams to move from early phase trials to commercial launch with confidence.
Our GSCCs are strategic hubs, designed to amplify CGT program growth. By integrating logistics, biostorage, cryopreservation, and consulting into a single, coordinated system, programs can scale smarter while reducing risk and accelerating outcomes. In a field where precision and quality define success, this integrated approach provides the infrastructure and expertise needed to move programs forward confidently.