Support for Commercial Programs
Commercial Supply Chain Solutions for Global Scalability Without Compromise
Partner with Cryoport Systems to deliver therapies worldwide with compliance and confidence. Every dose, every patient, every time.
Commercialization is the moment where precision meets scale. After years of trials and regulatory hurdles, your therapy is finally ready for market, but the complexity of widescale (and oftentimes global) distribution introduces new risks. At this stage, the stakes are higher than ever. Every shipment represents a patient waiting for a life-changing therapy, and any disruption can lead to costly delays or compounding downstream impact. Sponsors need a supply chain partner who can deliver global scalability without sacrificing compliance or reliability, mitigating risks like shipping delays, customs issues, and vendor fragmentation.
Cryoport Systems provides that assurance through our single-vendor supply chain platform that integrates logistics, BioServices and biostorage, cryopreservation, and consulting under one cohesive end-to-end framework. Our solutions are designed to anticipate challenges and mitigate risk, maintaining continuity from API to patient. With our built-in geographic redundancies, validated shipping systems, ISO-certified workflows, and track record of success that spans decades, we ensure your commercial supply chain operates with precision and resilience. With contingency planning built into every process, we provide resilience against disruptions and maintain compliance across every lane.
A Unified Platform for Global Commercial Success
End-to-end supply chain support that protects patient safety and ensures scalability
Support Upstream of Manufacturing
Build a foundation that scales without compromise
Commercial success starts with upstream precision. Inconsistent processes during tech transfer or kit production can create bottlenecks that ripple through global distribution. Cryoport Systems mitigates these risks by embedding standardization and compliance into upstream workflows, including validated packaging, kit design, standardized cryopreservation of leukapheresis-derived starting materials, and biostorage planning. Our experts collaborate with your team to create contingency strategies that anticipate commercial demand. By leveraging our integrated platform, you gain continuity from manufacturing to patient delivery, supported by risk-based planning and audit-ready documentation. This proactive approach ensures that your commercial supply chain is resilient, scalable, and ready for global expansion.
- Validated collection and manufacturing kit design and production for consistent global deployment
- Integrated GMP-compliant biostorage for inventory control and to enable just-in-time delivery to manufacturing
- Standardized cryopreservation processes for consistent starting material that extends manufacturability
- Risk-based logistics planning to anticipate downstream needs and plan for surges in demand
Upstream readiness is the backbone of commercial success. Cryoport Systems ensures that every process supports scalability and compliance, reducing risk and accelerating time-to-market. Our solutions create a seamless transition from manufacturing to distribution, eliminating inefficiencies that could compromise patient access. By partnering with us, you gain confidence that your supply chain is built for resilience and growth to drive commercial performance.
Support Downstream of Manufacturing
Ensure uninterrupted patient access around the globe
Commercial distribution introduces challenges that demand precision and speed. Sponsors must manage large-scale deliveries, maintain compliance across multiple geographies, and respond to market fluctuations, all without sacrificing reliability. Cryoport Systems delivers continuity through a single-vendor platform that integrates logistics, biostorage, and QP release under one roof. Our global network and geographic redundancies ensure uninterrupted delivery even during regional disruptions. With ISO-certified workflows and Chain of Compliance® documentation, we guarantee reproducibility and audit-ready transparency at scale. Our experts provide proactive monitoring and contingency planning to keep timelines intact and patients protected. By embedding resilience into every step, Cryoport Systems transforms downstream complexity into predictable performance.
- Global logistics network with built-in redundancies
- Industry’s largest fleet of wholly owned shipping systems for fast turn
- ISO 21973-certified workflows for compliance assurance
- Chain of Compliance® for full traceability and audit readiness
- Cryoshuttle® support in select areas for secure first and last mile pickup & delivery
- Qualified Person (QP) and regulatory support for release into the EU
Downstream operations are where patient safety meets operational discipline. Cryoport Systems provides the infrastructure and expertise to deliver therapies worldwide without compromise. Our solutions reduce variability, safeguard compliance, and ensure uninterrupted access for patients with standardized workflows and operations across our global network of facilities. By partnering with Cryoport Systems, you gain a flexible and scalable commercial supply chain that performs under pressure.
Cryopreservation for Commercial Continuity
Protect product integrity from initial draw to manufacturing to patient
Cryopreservation of starting material is critical to maintaining product integrity during global distribution. Variability in storage or handling can lead to costly recalls and regulatory challenges. Cryoport Systems delivers standardized cryopreservation solutions through our IntegriCell® platform, designed for commercial scalability. Our automated closed processes reduce contamination risk and maintain reproducibility while extending manufacturability of these sensitive starting materials, enabling seamless global deployment that incorporates flexibility as commercial programs rapidly scale. By implementing these solutions early, sponsors avoid disruptions caused by fragmented cryopreservation strategies. Our experts provide validated tech-transfer packages and compliance alignment to protect your materials throughout the supply chain. Combined with integrated biostorage and logistics, Cryoport Systems creates a framework that safeguards integrity from initial draw into manufacturing and through to patient dosing.
- Automated closed cryopreservation processes for consistency
- Integrated biostorage for GMP compliance
- Risk-based monitoring and documentation for audit readiness
- Scalable solutions for global commercial expansion
Cryopreservation of leukapheresis-derived starting materials is a safeguard for scalability of autologous cell therapy programs. Cryoport Systems ensures that every sample is preserved with precision, reducing variability and protecting patient safety while extending manufacturability and offering integrated biostorage for just-in-time delivery of cryopreserved materials to manufacturing. Our standardized solutions create continuity across sites and phases, enabling scalability without compromise. By partnering with us, you gain confidence that your materials will maintain integrity throughout the trial lifecycle.
BioServices for Commercial Efficiency
Streamline operations with integrated kit production and biostorage
Commercial distribution demands operational efficiency at scale. Fragmented BioServices can introduce delays, compliance risks, and even unnecessary costs. Cryoport Systems eliminates these challenges through integrated solutions that combine BioServices like kit production, biostorage, and secondary packaging and labeling with our integrated logistics and supply chain management under one platform. Our experts design and produce validated kits for collection, manufacturing, and administration tailored to your commercial requirements, with the required regional differentiation, ensuring consistency across global markets. By managing these processes within a single-vendor relationship, we reduce operational burden and eliminate the need for multiple handoffs. Our GMP-aligned biostorage facilities provide secure, compliant housing for sensitive materials, supported by continuous monitoring and audit-ready documentation. This level of integration streamlines workflows, accelerates timelines, and positions your program for uninterrupted patient access as you scale worldwide.
- Validated kit production for global consistency
- GMP-compliant biostorage for inventory control
- Qualified Person (QP) release for European expansion
- Integrated logistics for end-to-end continuity
- Just-in-time delivery of kits alongside shipping systems and materials
- Continuous monitoring and documentation for compliance assurance
- Risk-based planning to seamlessly navigate surges in demand
BioServices are the backbone of commercial efficiency. Cryoport Systems delivers these services within a unified platform, reducing complexity and safeguarding compliance. Our solutions create continuity across every touchpoint, enabling sponsors to focus on patient access rather than supply chain management. By partnering with us, you gain a strategic advantage that accelerates progress and protects product integrity.
Consulting and Advisory Support for Market Readiness
Expert guidance to navigate global complexity and ensure compliance
Commercial distribution introduces regulatory and operational challenges that require expert guidance. Cryoport Systems provides consulting and advisory services designed to align your supply chain strategy with global compliance standards and market readiness. Our experts collaborate with your team to develop risk mitigation plans, shipping lane qualifications as new lanes open to support patients in expanding geographies, and continuity strategies that anticipate future needs. By embedding these practices early, sponsors avoid costly disruptions and maintain momentum toward patient delivery. This proactive approach ensures that your supply chain remains resilient, compliant, and ready for expansion as your patient populations grow worldwide.
- Shipping risk assessments to proactively mitigate risk in your expansion strategy
- Shipping lane qualifications to plan for geographical expansion of patient populations
- Commercial runway planning and compliance readiness
- Import/export expertise for international distribution
- Strategic insight from thousands of advanced therapy programs
Consulting and advisory services are essential for navigating the complexity of commercial distribution. Cryoport Systems provides the expertise and foresight to help you proactively plan for the growth and demands of your commercial program. Our consulting and advisory solutions reduce uncertainty and mitigate risk, creating a clear path to global patient access for commercialized therapeutics.
Shipping Systems for Global Reliability
Deliver every dose on time with built-in redundancies
Commercial distribution leaves no room for delays or errors. Every shipment represents a patient waiting for therapy, and any disruption can lead to compounding downstream impacts like costly recalls and reputational damage. Cryoport Systems eliminates these risks with the industry’s largest, fully owned fleet of custom-engineered and validated shipping systems alongside geographic redundancies that keep your supply chain moving, even during regional disruptions or force majeure events. Unlike fragmented networks, our single-vendor model ensures immediate turnaround without dependency on third-party providers. Smartpak™ monitoring technology and Cryoportal® logistics management platform integration provide continuous oversight, enabling proactive intervention before issues escalate. Combined with our Veri-Clean® decontamination and robust requalification processes and pre-cleared import/export lanes, we deliver unmatched reliability and compliance across global markets. This infrastructure ensures that your therapies arrive on time, every time, without compromise.
- Fully owned shipper fleet for immediate availability across temperature ranges
- Geographic redundancies across global facilities for contingency coverage
- Smartpak™ condition monitoring devices and Cryoportal® for continuous monitoring and proactive intervention
- Veri-Clean® decontamination and robust requalification for validated system integrity at every use
Shipping systems are the backbone of commercial success. Cryoport Systems combines technology, infrastructure, and contingency planning with industry-leading quality and compliance to ensure uninterrupted patient access worldwide. Our approach eliminates single points of failure and reduces the risk of costly delays or recalls. By partnering with us, you gain a supply chain that performs under pressure and scales with demand.
Quality & Compliance for Risk Mitigation
Protect your market authorization with proactive compliance
Commercial operations face intense regulatory scrutiny, and compliance gaps can result in recalls, penalties, or even loss of market confidence. Cryoport Systems embeds quality and compliance into every process, ensuring that your therapies move through a supply chain that has been proactively designed for resilience. Our ISO 21973 certification validates our Chain of Compliance® framework, delivering full traceability from manufacturing to patient. Every shipper undergoes Veri-Clean® decontamination and full requalification at every use to guarantee physical integrity and LN2 capacity, while continuous monitoring technology provides full trackable, traceable visibility. We maintain extensive historical data to support audits and risk-based lane qualifications, reducing uncertainty and strengthening regulatory confidence. Combined with proactive contingency planning and audit-ready documentation, Cryoport Systems ensures that your commercial supply chain meets the highest standards globally.
- ISO 21973-certified workflows for global compliance
- Chain of Compliance® for full traceability and audit-readiness
- Veri-Clean® decontamination and full system requalification to ensure shipper integrity
- Continuous monitoring and historical data for risk-based planning and decision making
- Audit-ready documentation and full Chain of Compliance® history of all shipments and equipment
Quality and compliance are non-negotiable in commercial distribution. Cryoport Systems delivers a framework that protects patient safety, secures market authorization, and mitigates risk at scale as your commercial program reaches new patient populations around the world. Our proactive strategies anticipate challenges before they impact operations, ensuring uninterrupted delivery and regulatory alignment. By partnering with us, you gain confidence that every shipment meets the highest standards.
Featured Resources
Article
Scale Smarter: How Global Supply Chain Centers Amplify CGT Program Growth
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…
Article
Weathering the Storm: Cryoport Systems’ Proactive Risk Mitigation During Hurricane Beryl
During Hurricane Beryl’s landfall in Texas, Cryoport’s proactive risk mitigation strategies ensured a seamless, uninterrupted experience for our clients. Cryoport Systems’ Houston Global Supply Chain Center, central facilities for biostorage and logistics, upheld stringent security measures and continuity…
Case Study
When Every Hour Counts: How Cryoport Systems Rapidly Mobilized to Protect INmune Bio’s Critical Clinical Materials
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…
Cryoport Systems is your single vendor commercial engine to deliver global scalability. You’ve worked this hard to bring your product to market, don’t put your market authorization to chance with anything less than the best.
- IntegriCell® Cryopreservation
Consistent, high-quality leukapheresis starting material.
Learn More >> - BioServices & Biostorage
Integrated solutions to support advanced therapies.
Learn More >> - Consulting & Advisory Services
Our team of experts can help de-risk your logistics.
Learn More >> - Shipping Solutions
Temperature-controlled packaging solutions.
Learn More >> - Transportation
Transportation of commodities at various temperatures.
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Cryoport Systems is Enabling the Outcome™ through our unparalleled supply chain platform.
Offering a comprehensive scope of robust supply chain management solutions and trusted logistics.
Cryoport Systems was established by a team of doctors dedicated to serving the life sciences through expert logistics support. Today, our partnership capabilities have evolved beyond logistics into a robust platform of supply chain solutions that supports every stage and phase of the life sciences research, development, and manufacturing process. Our comprehensive platform of solutions makes Cryoport Systems a standalone vendor that can support all aspects of the temperature-controlled supply chain.
LEARN MORE ABOUT HOW CRYOPORT SYSTEMS IS ENABLING THE OUTCOME™
