Support for Pre-Clinical Programs
Pre-Clinical Solutions for Therapeutic Developers
Start strong by building a scalable, compliant supply chain from day one
Pre-clinical development is the start of your therapeutic’s journey, and it’s where the foundational decisions you make today can impact the future success of tomorrow. At this stage, uncertainty often surrounds process design as you consider regulatory expectations and scalability. Cryoport Systems transforms that uncertainty into confidence by partnering with you early to establish GMP-ready, globally scalable workflows and support.
Our integrated, end-to-end supply chain platform ensures your materials are protected and compliant, prepared for seamless progression into Phase I clinical trials and beyond. Within a single-vendor relationship, you eliminate fragmentation and reduce operational burden, which frees your team to focus on science while we manage the complexity of your supply chain. From defining a standardized cryopreservation workflow to implementing risk-based strategies, we help you build clinical-grade habits early, ensuring reproducibility and uninterrupted supply chain assurance. Beginning your partnership with Cryoport Systems from these early, pre-clinical stages sets you up for success across every phase of development.
Your Partner from Bench to Bedside
Comprehensive solutions designed for pre-clinical success
Support Upstream of Manufacturing
Optimize Early Processes for Future Scalability
Before your first batch is produced, upstream decisions shape the efficiency and compliance of your entire program. Cryoport Systems helps you design a supply chain management strategy that aligns with compliance standards from the start, reducing costly rework later. Our consulting and advisory team collaborates with you to anticipate downstream needs, ensuring that your pre-clinical approach is compatible with clinical and commercial requirements. By integrated biostorage and cryopreservation strategies early, you create a foundation for reproducibility and scalability. Our global network and standardized processes allow you to plan IND-enabling studies with confidence, knowing your material handling meets clinical expectations. With Cryoport Systems, upstream planning becomes a strategic advantage rather than a bottleneck.
- Define GMP and ISO 21973 compliance before your first batch
- Early biostorage setup for seamless transition
- Global facility access for worldwide study planning
- Standardized processes and compliance across regions
- Integrated cryopreservation strategies for reproducibility of starting materials
Early-stage planning is the foundation for a successful therapeutic program. By engaging Cryoport Systems at the pre-clinical stage, you gain a partner who understands the importance of scalability and compliance from the very beginning. Every process we help you design is intended to support smooth transitions into clinical and commercial phases without unnecessary rework. Our team works alongside yours to anticipate challenges and implement solutions that protect both timelines and budget. With this proactive approach, you are able to move forward with confidence, knowing your upstream decisions are setting the stage for long-term success.
Support Downstream of Manufacturing
Protect and Deliver Your Pre-Clinical Materials with Confidence
Once your materials are manufactured, downstream logistics become critical to maintaining integrity and compliance. Cryoport Systems provides validated shipping systems, continuous monitoring, and Chain of Compliance® tracking from your first vial onward. Our fully-owned fleet of shipping systems (the largest in the industry) eliminates bottlenecks, ensuring timely delivery for studies and tech transfer packages. Veri-Clean® and requalification processes guarantee every shipper meets the industry’s most stringent quality standards, while ISO 21973 certification aligns your processes with global expectations. Risk-based lane selection uses pre-clinical shipments to pre-qualify routes for Phase I, reducing surprises later. With Cryoport Systems, your downstream logistics are secure and strategically aligned.
- Continuous monitoring of every shipment throughout transit
- Chain of Compliance® and audit-ready data for IND readiness
- ISO 21973-certified processes
- Shipping risk assessment and lane qualifications future-proof your distribution strategy
Managing downstream logistics effectively is essential for protecting the integrity of your materials and meeting regulatory requirements. Cryoport Systems ensures that every shipment is handled with precision and documented for full audit readiness. Our processes are designed to minimize risk and maintain continuity as you progress toward clinical phases. By leveraging our expertise and infrastructure, you can avoid delays and maintain confidence in your supply chain from the earliest stages, making your downstream operations a reliable foundation for future success.
Cryopreservation that Safeguards Your Science
Preserve Integrity from Day One
Cryopreservation is a critical safeguard for your therapy’s viability. Cryoport Systems’ IntegriCell® solution ensures consistent, validated cryopreservation processes that protect cell integrity and viability throughout pre-clinical development. By standardizing cryopreservation early with our automated closed process, you reduce variability and enable smooth tech transfer into GMP environments. Our experts guide you through best practices and process validation, ensuring your samples remain stable and compliant. With IntegriCell, you build a foundation for reproducibility and regulatory confidence.
- Validated cryopreservation protocols
- Reduced variability across collection sites & batches
- Seamless transition from pre-clinical to GMP environments
- Enhanced sample integrity and viability
Cryopreservation is a critical component of your development strategy, and getting it right early can prevent costly setbacks later. Cryoport Systems provides the expertise and infrastructure needed to ensure your samples remain viable and compliant throughout the pre-clinical phase. Our approach focuses on consistency and reproducibility, giving you confidence in every batch. By partnering with us, you create a strong foundation for future phases and regulatory success. This level of assurance allows your team to focus on advancing science while we safeguard your materials.
Integrated BioServices for Standardization and Scalability
Streamline Collection, Storage, and Management from the Start
Pre-clinical programs require a comprehensive approach to sample handling and standardization. Cryoport Systems’ BioServices provide GMP-ready biostorage combined with solutions that simplify collection and manufacturing processes. Our custom sample collection kits and manufacturing kits ensure consistency across sites, reducing variability and supporting reproducibility as you scale. Clinical sample management capabilities allow you to track and maintain integrity throughout pre-clinical and into clinical phases, creating a seamless continuum of care for your materials. With global facilities and standardized processes, you gain confidence that every sample is handled according to strict compliance standards. By integrating BioServices early, you eliminate fragmentation and prepare for smooth transitions into IND and beyond. Cryoport Systems delivers a unified platform that supports your science and accelerates your path forward.
- GMP-ready biostorage facilities across the globe
- Standardized sample collection kits for consistency from the first draw
- Manufacturing kits with just-in-time delivery to streamline production workflows
- Clinical sample management for scalable support as your program grows
- Continuous monitoring and audit-ready documentation
BioServices are a critical enabler of efficiency and compliance in pre-clinical development. By leveraging Cryoport Systems’ integrated solutions, you create a standardized framework that reduces risk and supports scalability. Our approach ensures that every sample, from collection to storage, meets rigorous quality standards and remains fully traceable. This level of control and visibility empowers your team to focus on advancing science while we manage the complexity of logistics and compliance. With Cryoport Systems, your BioServices strategy becomes a competitive advantage that carries through every phase of development.
Expert Guidance for Pre-Clinical Success
Navigate Complexity with Confidence
Pre-clinical development involves critical decisions that impact timelines, budgets, and regulatory outcomes. Cryoport Systems’ consulting and advisory services provide strategic insights that help you plan for scalability and compliance, mitigating risks well in advance. Our experts collaborate with your team to perform strategic risk assessments and select optimal shipping lanes, helping you anticipate regulatory requirements. By leveraging our experience across thousands of programs (and more than a million successful shipments), you gain a partner who understands the nuances of cell and gene therapy logistics. With Cryoport Systems, you gain the insight required to make informed decisions that accelerate progress and reduce uncertainty.
- Risk-based logistics planning
- Regulatory readiness support
- Packaging performance qualification
- Custom packaging and accessory development
- Insights from global program experience
Expert guidance during pre-clinical development can significantly influence the success of your program. Cryoport Systems offers the knowledge and experience needed to align your processes now with future phases, reducing risk and improving efficiency. By working hand-in-hand with your team, we help you make decisions today that support the long-term goals and regulatory compliance of tomorrow. This level of partnership ensures that your program is positioned for success from the very beginning.
Validated Shipping Solutions for Pre-Clinical Needs
Deliver with Confidence
Shipping pre-clinical materials requires precision and reliability. Cryoport Systems has the industry’s largest fully-owned fleet of validated shippers designed for cryogenic and controlled-temperature transport. Each shipper undergoes Veri-Clean® decontamination and full requalification before every use, ensuring compliance and safety for every shipment. Our continuous monitoring and Chain of Compliance® tracking give you full visibility and audit-ready documentation. With ISO 21973-certified processes and risk-based lane selection, you can trust that your materials will arrive intact and on time.
- Industry’s largest, wholly owned fleet of shipping systems
- Custom-engineered shipping solutions for the life sciences
- Veri-Clean decontamination and requalification processes
- Continuous condition monitoring and audit-ready documentation
- ISO 21973-certified processes and industry-leading quality standards
- Risk-based lane selection for future scalability
Shipping is a critical link in your supply chain, and it requires a partner who prioritizes reliability and compliance. Cryoport Systems delivers shipping solutions that meet the highest standards for safety and documentation. Our processes are designed to support your program as it scales, ensuring continuity and reducing risk. By integrating shipping with other services, we create a streamlined experience that simplifies complexity. This approach gives you confidence that your materials will arrive as expected, every time.
Compliance Built into Every Step
Reduce Risk, Increase Confidence
Regulatory compliance and risk mitigation start from the earliest, pre-clinical stages. Cryoport Systems embeds quality into every process, from cryopreservation to shipping. Our ISO 21973 certification, Chain of Compliance® tracking, and continuous monitoring provide a robust framework for audit readiness. By implementing risk-based strategies early, you avoid costly delays and ensure smooth progression into clinical phases. With Cryoport Systems, compliance is a foundation for future success.
- ISO 21973-certified processes
- Chain of Compliance® audit trail
- Continuous monitoring of every shipment
- Veri-Clean® decontamination process
- Requalification of every shipping system before every use
Compliance and risk management are essential for maintaining momentum and meeting regulatory expectations. Cryoport Systems integrates these principles into every aspect of your supply chain, starting from the earliest stages. Our proactive approach helps identify and mitigate potential issues before they impact timelines, reducing uncertainty and improving efficiency. By partnering with us, you gain a framework that supports audit readiness and long-term success, ensuring your program is prepared for every challenge and milestone ahead.
Featured Resources
Article
The Hidden Risks in Your Supply Chain: How Regulatory Support Can Save Your CGT Program
The temperature-controlled supply chain has become so much more than a straightforward logistics function, especially for advanced therapies. It has quickly evolved into a critical extension of your manufacturing process, your clinical trials, and your path to commercialization. Understanding…
Webinar
Breaking Through Supply Chain Bottlenecks in CGT
In this on-demand webinar, experts from Cryoport Systems and Advent Bioservices delve into the critical challenges of managing the cell and gene therapy supply chain. From sourcing and managing starting materials to ensuring the safe, timely delivery of therapies to patients, this webinar offers insights into the best practices and innovative strategies…
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 the scalability of…
Jumpstart your pre-clinical supply chain with Cryoport Systems and build a strategy that’s scalable, fully compliant, and ready for every phase ahead.
- 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™
