BioServices for
Biopharma Development
BioServices for Comprehensive Support of Therapeutic Programs
A global network of flexible, integrated services that help drive efficiency and scale
Cryoport Systems’ BioServices offering is designed to provide comprehensive and compliant support for the unique needs of biologics and advanced therapy development and commercialization. Our services extend beyond logistics to encompass critical elements such as biostorage, kit production, secondary packaging and labeling, clinical sample management, and regulatory and QP services. This holistic approach ensures that every component of your supply chain is optimized for quality and security with the flexibility you need as your program scales.
By integrating BioServices into our end-to-end platform, we help sponsors, CROs, and CDMOs alike streamline operations, reduce risk, and maintain compliance across global markets. Whether you are in early-phase development or scaling for commercial launch, our solutions are tailored to meet the stringent requirements of cell therapy, gene therapy, and biologics programs with integrated support within our end-to-end supply chain platform approach.
Integrated BioServices for Advanced Therapy & Biologics Supply Chains
A unified platform for critical services across development and commercialization
Cryoport Systems’ BioServices offering is a cornerstone of our end-to-end supply chain platform, designed to address the complex needs of advanced therapies. By combining biostorage, kit production, packaging, labeling, sample management, and regulatory expertise, we deliver a seamless experience that minimizes risk and maximizes efficiency. Our integrated approach ensures that every step from collection to administration is supported by validated processes and industry-leading compliance standards. This alignment reduces operational complexity for sponsors and their partners, enabling faster timelines and greater confidence in product integrity. With Cryoport Systems, BioServices are not standalone solutions but are interconnected components that strengthen the entire end-to-end supply chain ecosystem. Together, these services form a comprehensive platform that supports innovation and accelerates patient access.
Biostorage
Secure, compliant storage for critical materials
Cryoport Systems offers advanced biostorage solutions designed to protect sensitive materials throughout development and commercialization. Our facilities are equipped with state-of-the-art technology and validated processes to ensure the highest levels of security and compliance. We provide flexible storage options for a wide range of temperatures, including cryogenic conditions, to meet the unique requirements of biologics as well as cell and gene therapies. Continuous monitoring and redundant systems safeguard against environmental fluctuations, ensuring material integrity at all times. Our global network of storage facilities enables strategic positioning to support clinical and commercial programs worldwide. By integrating biostorage within our full end-to-end supply chain platform, we deliver a streamlined solution that reduces complexity and risk. This comprehensive approach ensures that your materials remain secure, traceable, and ready for deployment when needed.
- Support for all temperature bands, including cryogenic and ultra-cold storage options
- Continuous monitoring and state-of-the-art, redundant systems
- Global network of validated and GMP-compliant facilities
- ISO-certified processes and documentation
- Integrated within full platform of end-to-end supply chain solutions
More than a holding point, biostorage is a critical component of therapeutic success. Cryoport Systems ensures that every aspect of storage meets the highest standards for quality and compliance. Our integrated approach reduces logistical challenges and provides full visibility into your inventory. With our expertise and infrastructure, you can trust that your materials are protected and positioned for timely deployment.
Custom Kit Production (Collection, Manufacturing, and Administration Kits)
Custom-designed kits for every stage of therapy development
Cryoport Systems provides comprehensive kit production services to support the collection, manufacturing, and administration of advanced therapies. Our kits are designed to meet protocol-specific requirements and ensure compliance with global regulatory standards. Each kit is assembled using validated, temperature-controlled processes and quality-controlled components to safeguard sample integrity. We offer flexibility in design, enabling customization for cell therapy, gene therapy, and biologics programs. By integrating kit production within our full BioServices and end-to-end supply chain platform, we streamline distribution and reduce operational complexity. This approach ensures that every kit arrives complete, compliant, and ready for use in critical workflows.
- Customizable kits for collection, manufacturing, and drug administration
- GMP-compliant assembly and validation
- Just-in-time and bulk delivery options for scalable support
- Tailor-made for regional requirements for consistency across the globe
- Integrated within global storage, logistics, and supply chain services
Kit production is a vital link in the chain of advanced therapy development. Cryoport Systems ensures that every kit meets the highest standards for quality and compliance, supporting every stage of your therapy’s journey from initial collection of patient or donor materials to manufacturing of the drug product to final patient administration. Our integrated approach reduces risk and accelerates timelines by aligning kit production with your program’s needs. With global reach and proven expertise, we deliver kits that support successful outcomes at every stage while adhering to the industry’s most stringent quality and compliance standards.
Secondary Packaging and Labeling
Validated packaging and labeling for global compliance
Cryoport Systems offers secondary packaging and labeling services to ensure that your materials meet regulatory and logistical requirements worldwide. Our solutions include validated packaging configurations that protect product integrity during transit and storage. We provide temperature-controlled, compliant labeling that aligns with regional regulations and supports traceability throughout the supply chain. By integrating these services with our greater logistics, BioServices, and supply chain platform, we deliver a streamlined process that reduces complexity and risk. Our team works closely with sponsors and partners to customize packaging and labeling for cell therapy, gene therapy, and biologics programs. This comprehensive approach safeguards your materials and supports successful global distribution.
- Validated secondary packaging solutions
- Regulatory-compliant labeling for global markets
- Integrated with biostorage and logistics solutions
- Customization to support specific program requirements
Secondary packaging and labeling are critical for maintaining compliance and product integrity. Cryoport Systems provides solutions that meet stringent regulatory requirements and support global distribution. Our integrated approach reduces operational challenges and ensures accuracy across every shipment. With proven expertise and validated processes, we help you navigate complexity with confidence, protecting your materials and maintaining compliance at every step.
Clinical Sample Management
Comprehensive management for clinical trial samples
Cryoport Systems delivers clinical sample management services that ensure the integrity and traceability of samples throughout the trial lifecycle. Our solutions include secure storage, validated handling, and compliant transportation for temperature-controlled clinical sample management. We provide full visibility into sample status through robust documentation systems. By integrating sample management within our end-to-end supply chain platform approach, we streamline workflows and reduce risk for sponsors and CROs. Our global network supports multi-site trials and enables efficient coordination across regions. With expertise in advanced therapies, we tailor solutions to meet protocol-specific requirements and regulatory standards. This comprehensive approach ensures that your samples remain secure, compliant, and ready for analysis.
- Secure storage and validated handling processes
- Continuous monitoring and traceability systems
- Integrated with end-to-end supply chain support
- Global support for multi-site trials
- Compliance with global regulatory requirements
Clinical sample management is essential for maintaining data integrity and trial success. Cryoport Systems provides solutions that safeguard samples and streamline operations across global studies. Our integrated approach reduces complexity and enhances visibility for sponsors and CROs. With proven expertise and infrastructure, we help you manage samples with confidence and compliance, from initial collection to analysis and through to drug return and destruction.
Regulatory & QP Services
Expert guidance for global compliance and quality assurance
Cryoport Systems offers regulatory and Qualified Person (QP) services to help sponsors navigate complex compliance requirements. Our team provides expertise in global regulations, ensuring that your materials meet all necessary standards for import, export, and distribution. We deliver QP release services for clinical and commercial programs in the European Union, supported by validated processes and robust documentation. By integrating regulatory support with our BioServices platform, we streamline compliance and reduce operational risk. Our solutions are tailored to the unique needs of cell therapy, gene therapy, and biologics programs. This comprehensive approach helps you maintain compliance and accelerate timelines for global market access.
- Regulatory expertise for global compliance
- QP release services for clinical and commercial programs
- Integrated within BioServices and full end-to-end supply chain platform
- Tailored solutions specific to your program requirements and needs
Regulatory and QP services are critical for ensuring compliance and enabling global distribution. Cryoport Systems provides the expertise and infrastructure needed to navigate complex requirements with confidence. Our integrated approach reduces risk and accelerates timelines for sponsors and partners with proven processes and global reach, helping you achieve compliance and maintain quality throughout the supply chain.
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Featured Resources
Video
Comprehensive, Integrated BioServices
BioServices from Cryoport Systems provide an end-to-end solution for biopharmaceutical companies conducting clinical trials and distributing advanced therapies. With decades of expertise in cell and gene therapy logistics, our team understands the critical nature of handling and transporting sensitive materials. Our global infrastructure…
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…
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. Learn how to optimize your supply chain, overcome logistical barriers, and ensure the quality and viability of life-saving treatments from start to finish. Ready to streamline your entire biomaterials…
Stay informed with expert insights from our team of specialists who understand the challenges you face. Our articles bring you practical strategies and industry updates to keep your programs moving forward.
BioServices Support Across Therapeutic Types
Comprehensive solutions for every stage of biotherapeutic development
Advanced therapy development is complex, and each stakeholder faces unique challenges that require specialized support. Cryoport Systems’ BioServices platform is designed to adapt to these needs, providing integrated solutions that align with the priorities of CROs, CDMOs, and sponsors across cell therapy, gene therapy, and biologics programs. For CROs, speed and compliance in clinical trial execution are critical whereas for CDMOs, manufacturing efficiency and quality assurance drive success. Cell therapy programs demand cryogenic precision and chain-of-identity safeguards, while gene therapy requires secure handling of viral vectors and regulatory rigor. Biologics programs prioritize scalability and global distribution without compromising product integrity. Our services, including biostorage, kit production, packaging, labeling, sample management, and QP release, are customized to meet these distinct requirements. By leveraging our end-to-end platform, we reduce risk, accelerate timelines, and maintain compliance across every phase. With global infrastructure and validated processes, we provide continuity and confidence in navigating complexity and delivering life-changing therapies worldwide.
Support for CROs
Accelerating trial execution with compliant, integrated services
Cryoport Systems partners with CROs to simplify the execution of advanced therapy clinical trials. Our integrated BioServices platform provides biostorage, kit production, sample management, and regulatory support tailored to protocol-specific requirements. By leveraging validated processes and continuous monitoring systems, CROs can ensure compliance and maintain data integrity across global sites. Our solutions reduce operational complexity, enabling CROs to focus on trial management and patient outcomes. With strategic storage locations and efficient kit distribution, we help accelerate timelines and minimize risk. Our expertise in cell therapy, gene therapy, and biologics ensures alignment with the unique demands of these programs. Together, we deliver a seamless experience that supports successful trial execution.
Support for CDMOs
Optimizing manufacturing workflows with integrated BioServices
CDMOs face the challenge of balancing production efficiency with strict compliance requirements. Cryoport Systems supports CDMOs by providing BioServices that integrate seamlessly into manufacturing workflows. Our offerings include GMP-compliant biostorage for raw materials and intermediates, custom kit production for manufacturing steps, and validated packaging for finished products. Continuous monitoring ensures material integrity throughout production and distribution. By aligning our services with CDMO operations, we help reduce bottlenecks and maintain quality standards. Our global infrastructure supports multi-site manufacturing and enables efficient coordination across regions. With expertise in advanced therapies, we tailor solutions to meet the unique requirements of cell therapy, gene therapy, and biologics manufacturing. This partnership strengthens supply chain resilience and accelerates delivery timelines for sponsors.
Support for Cell Therapy Programs
Precision and compliance for living cell products
Cell therapy programs demand absolute precision in handling living cells, where any deviation can compromise patient safety. Cryoport Systems provides BioServices specifically designed for these critical requirements. Our cryogenic biostorage solutions maintain ultra-low temperatures to preserve cell viability, while custom kits ensure standardized collection, manufacturing, and administration with options for just-in-time and bulk delivery to best suit your phase of development and program requirements with the flexibility to support your program as it scales. Chain-of-identity and chain-of-custody safeguards are embedded into every process to protect patient-specific materials, and our continuous monitoring and redundant systems provide assurance throughout storage and transit. By integrating these services into our end-to-end platform, we reduce risk and streamline workflows for sponsors and partners. This comprehensive approach supports successful outcomes from early-phase trials through commercial launch.
Support for Gene Therapy Programs
Secure handling and compliance for genetic medicines
Gene therapy programs involve highly sensitive materials such as viral vectors that require specialized handling and regulatory oversight. Cryoport Systems provides BioServices tailored to these unique challenges. Our secure biostorage solutions maintain controlled conditions for genetic materials, while custom kits support standardized collection, manufacturing, and administration with both just-in-time and bulk delivery options to best suit your program requirements at every phase. Validated packaging and labeling ensure compliance with global regulations and protect product integrity during transit. Continuous monitoring and documentation provide transparency throughout the supply chain. By integrating these services into our full end-to-end supply chain platform, we help sponsors reduce risk and accelerate timelines within a single-vendor relationship. Our expertise in gene therapy logistics ensures alignment with stringent quality standards.
Support for Biologics Programs
Scalable solutions for complex biologic products
Biologics programs prioritize scalability and global distribution while maintaining product integrity. Cryoport Systems offers BioServices that support these objectives through secure biostorage, custom kit production, clinical sample management, and validated packaging solutions. Our services are designed to handle large volumes and complex logistics without compromising compliance. Continuous monitoring and robust documentation safeguard biologic materials throughout storage and transit. By integrating these services into our end-to-end supply chain platform, we help sponsors streamline operations and reduce risk within a single-vendor relationship that defragments your supply chain. Our global infrastructure enables efficient coordination across clinical and commercial programs. This comprehensive approach ensures reliability and scalability for biologics development and distribution at every phase.
BioServices Support Across Phases of Development
Comprehensive solutions for every stage of biotherapeutic development
Cryoport Systems’ BioServices platform is designed to provide continuity and compliance across all phases of advanced therapy development. From pre-clinical research to global commercialization, our integrated services help sponsors, CROs, and CDMOs navigate complex requirements with confidence. Each stage of development presents unique challenges, from regulatory compliance to material integrity and even operational efficiency. Our solutions are tailored to meet these evolving needs. By leveraging our end-to-end platform, we reduce risk and accelerate timelines, maintaining industry-leading quality throughout the full development lifecycle. Whether supporting early-phase trials or scaling for commercial launch, Cryoport Systems delivers expertise and infrastructure that drive success. Our commitment is to help you bring life-changing treatments to patients worldwide.
Support for Pre-Clinical Programs
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 your supply chain and compliance. With Cryoport Systems, your BioServices strategy becomes a competitive advantage that carries through every phase of development.
Support for Phase I Programs
Standardize Collection, Storage, and Management
Phase I trials require precise coordination of sample collection, storage, and management. Cryoport Systems’ BioServices provide GMP-ready biostorage combined with standardized sample collection kits and manufacturing kits to reduce variability across sites. Our clinical sample management capabilities ensure full traceability and integrity throughout the trial lifecycle. With global facilities and continuous monitoring, you gain confidence that every sample meets compliance standards.
- GMP-ready biostorage facilities worldwide
- Standardized sample collection kits and manufacturing kits reduce variability
- Clinical sample management for full lifecycle oversight
- Continuous monitoring and audit-ready documentation
- Integrated logistics and cryopreservation support
Managing samples across multiple sites during Phase I can quickly become complex and susceptible to error. Cryoport Systems simplifies this challenge by delivering integrated BioServices that standardize collection, storage, and handling from the start. Our solutions reduce variability and maintain chain of custody while providing audit-ready documentation for regulatory submissions. This level of control both ensures patient safety and accelerates trial timelines. With Cryoport Systems, BioServices become a strategic asset that supports your program through every milestone.
Support for Phase II Programs
Standardize Collection, Storage, and Management Across Sites
Phase II trials introduce complexity that demands more than basic biostorage. As patient populations grow and trial sites expand internationally, sponsors need a solution that ensures consistency and compliance across every location. Cryoport Systems delivers integrated BioServices that combine GMP-ready biostorage with global kit production for sample collection and manufacturing. Our standardized kits reduce variability and simplify onboarding for new sites, while centralized biostorage facilities maintain chain of custody and audit-ready documentation. Clinical sample management capabilities provide full visibility into every step, ensuring reproducibility and regulatory alignment. By embedding these services early, you eliminate inefficiencies and prepare for seamless progression into Phase III and commercialization.
- Global GMP-ready biostorage facilities for centralized control
- Standardized collection and manufacturing kits for reproducibility
- Clinical sample management with full traceability
- Continuous monitoring and audit-ready documentation
- Integrated logistics and cryopreservation support for scalability
Managing samples across multiple geographies during Phase II can quickly become a source of risk and inefficiency. Cryoport Systems mitigates these challenges by delivering a unified BioServices framework that standardizes processes and ensures compliance worldwide. Our approach reduces variability while accelerating site onboarding, which provides the transparency regulators expect. By consolidating biostorage and kit production under one global partner, you avoid duplication and hidden costs while maintaining operational continuity. With Cryoport Systems, BioServices become a cornerstone of scalability and a safeguard for patient safety as your program advances toward Phase III.
Support for Phase III Programs
Simplify complexity with integrated BioServices and biostorage
Phase III trials demand operational efficiency at scale, and fragmented BioServices can introduce delays and compliance risks. Cryoport Systems eliminates these challenges through integrated solutions that combine kit production, secondary packaging and labeling, clinical sample management, biostorage, and logistics under one platform. Our experts design and produce custom collection and manufacturing kits tailored to your trial requirements, ensuring consistency across all sites. 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. Our Qualified Person (QP) and regulatory support enables global expansion and release of drug product into the EU. This level of integration streamlines workflows, accelerates timelines, and positions your program for seamless progression into commercialization.
- Custom kit design and production for trial-specific needs
- GMP-compliant biostorage solutions for material integrity
- Qualified Person (QP) release for European expansion
- Integrated logistics for end-to-end continuity
- Continuous monitoring and documentation for compliance assurance
- Risk-based planning to anticipate future scalability
BioServices are the backbone of operational efficiency during Phase III trials. 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 science rather than supply chain management. By partnering with us, you gain a strategic advantage that accelerates progress and protects patient safety, transforming BioServices into a driver of success.
Support for Commercial Programs
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.
