IntegriCell™ Cryopreservation

IntegriCell™ cryopreservation services are designed to maximize cellular viability and optimize the entire cryopreservation process. Utilizing state-of-the-art cryopreservation protocols, we ensure that the quality of cellular material is preserved (ideally within the critical 24-hour window post-collection). This approach is crucial for maintaining the integrity and effectiveness of manufacture-ready cryopreserved leukapheresis material, which forms the backbone of advanced cell therapies. Our commitment to high standards means that every step of the process is carefully managed to maximize cellular quality.

A key component of our process is the use of a GMP-compliant, closed automated system, which significantly reduces the risk of contamination and the associated quality variations that can arise from human intervention. This closed automation ensures that each batch of leukapheresis material is handled consistently, minimizing the potential for errors and enhancing overall reliability. By eliminating the variables introduced by manual handling, we achieve a higher level of standardization and quality control, which is essential for producing consistent cell therapy products.

Our approach extends the shelf life of cryopreserved starting material, allowing for the decoupling of collection from drug product production and manufacturing. Cryopreserving leukapheresis material within 24 hours post-collection ensures that the quality of the starting material is maintained over time, providing flexibility and efficiency in the manufacturing process. This capability not only supports better planning and resource allocation but also reduces costs and mitigates risks, ultimately leading to more successful outcomes in cell therapy development and delivery.

Standardized protocols are at the core of IntegriCell™ cryopreservation services, ensuring the consistency and quality of manufacture-ready cryopreserved leukopaks across our global network. By implementing uniform procedures across the cryopreservation process, we achieve unparalleled reliability. This dedication to standardization allows us to provide high-quality materials that meet the stringent requirements of cell-based therapies, supporting successful clinical and commercial applications worldwide.

Our experienced team, with over 25 years of expertise in cryopreservation, plays a crucial role in maintaining these high standards. Their deep understanding of cryopreservation science and technology ensures that every process is created and implemented with precision and care. By adhering to strict compliance standards, our team guarantees uniformity and reliability in every cryopreservation service, which is essential for producing consistent, high-quality cryopreserved leukapheresis material.

Global standardization further reduces variability and enhances the consistency of our cryopreserved products. By applying the same rigorous cryopreservation processes across all IntegriCell™ locations and facilities, we ensure that every manufacture-ready cryopreserved leukopak we produce meets our exacting standards. This approach minimizes the risk of discrepancies and variations, providing our clients with the confidence that their materials will perform consistently, regardless of where they are processed or which Cryoport Systems facility they are working with. Through this comprehensive standardization, IntegriCell™ delivers the exceptionally reliable and high-quality cryopreserved leukopaks that are essential for producing cell therapies.

Cryoport Systems’ IntegriCell™ cryopreservation services play a pivotal role in ensuring a smooth and efficient technology transfer for cell and gene therapy developers. Leveraging decades of expertise, our multidisciplinary team works closely with clients to establish and refine cryopreservation processes, facilitating a seamless transition into clinical trials or scaled manufacturing operations.

Our tech transfer process is built on aligning with each client’s unique needs. Led by our experienced MSAT team and working closely with project management, technical operations, analytical, and quality assurance teams, we conduct a thorough evaluation of processes and supporting documentation. This collaborative approach ensures that all procedures are tailored and optimized for scalability, while maintaining compliance and minimizing variability.

By integrating cryopreservation with our state-of-the-art logistics infrastructure, Cryoport Systems enables cell therapy developers to preserve and deliver manufacture-ready cryopreserved leukopaks with precision and consistency. This integration enhances manufacturing flexibility, streamlines timelines, and supports uninterrupted progress from development to commercialization. IntegriCell™ provides the expertise, infrastructure, and operational excellence needed to enable successful tech transfer for advanced therapies.

IntegriCell™ cryopreservation services significantly enhance manufacturing slot utilization, driving cost savings and maximizing product revenue for therapy developers. By offering manufacture-ready cryopreserved leukopaks, we provide a level of flexibility and reliability that is crucial for optimizing production schedules. This flexibility allows therapy developers to better align their manufacturing processes with their overall production goals, ultimately improving efficiency and throughput.

One of the key benefits of IntegriCell™ cryopreservation is the scheduling flexibility it offers. Unlike fresh, donor-derived cellular materials, which must be used within a narrow time frame, cryopreserved leukopaks can be stored and utilized as needed. This allows manufacturing to be initiated up to seven days a week, providing therapy developers with greater control over their production timelines. By alleviating the reactive time sensitivity associated with fresh materials, our cryopreservation services contribute to more efficient and predictable manufacturing operations.

Additionally, IntegriCell™ cryopreservation services help reduce backlogs and logistical challenges that can impede manufacturing success. With the ability to store and utilize cryopreserved materials as needed, advanced therapy developers can better manage their supply chain and production schedules, decreasing the risk of delays and disruptions. This results in enhanced manufacturing success rates and a more streamlined process from start to finish. By maximizing manufacturing efficiency, IntegriCell™ cryopreservation services support the timely and cost-effective development of cell-based therapies.

Cryoport Systems’ IntegriCell™ cryopreservation services provide comprehensive global support, ensuring the preservation and delivery of high-quality manufacture-ready cryopreserved leukopaks. With cryopreservation facilities strategically located in the U.S. and Europe, we offer geographic coverage that supports worldwide reach. This enables us to maintain the integrity and viability of critical materials while minimizing transportation times.

Our global capabilities are a cornerstone of IntegriCell™ services, supported by our network of facilities around the world. This extensive network allows for the efficient management of critical materials, ensuring they are preserved in optimal condition. By providing reliable and secure cryopreservation solutions, we enable the seamless integration of our services into global clinical trials, thereby enhancing the development and delivery of cutting-edge cell and gene therapies.

Partnering with Cryoport Systems provides comprehensive access to our integrated, temperature-controlled supply chain solutions to optimize costs, improve efficiencies, and mitigate risks. Our comprehensive approach ensures that all aspects of the cell therapy development process, from initial cryopreservation to the final drug product, are managed seamlessly through a single vendor relationship. This integrated service model provides advanced therapy developers with a streamlined experience, allowing them to focus on their core objectives while we handle the intricacies of the sensitive temperature-controlled supply chain.

Our end-to-end services encompass cryopreservation, BioServices and biostorage, shipping systems and logistics, and customized consulting for proactive risk mitigation, all managed under one contract. This integrated framework simplifies the process for biotech teams and Contract Development and Manufacturing Organizations (CDMOs), enabling them to concentrate on their primary business functions without the added complexity of coordinating multiple vendors. By consolidating these critical services, Cryoport Systems ensures a cohesive and efficient supply chain that supports the successful development and delivery of cell and gene therapies.

Minimizing touch points in the supply chain is a key strategy for reducing risk, and Cryoport Systems excels in this area by offering combined cryopreservation, logistics, and biostorage services. This integration not only enhances operational efficiency but also significantly mitigates potential risks associated with handling and transporting sensitive biological materials. By choosing Cryoport Systems as your end-to-end supply chain provider, you gain a reliable partner dedicated to maintaining the highest standards of quality and consistency throughout the entire process.

See how Cryoport Systems is Enabling the Outcome™

Through strategic partnerships, Cryoport Systems significantly enhances its supply chain capabilities to provide access to highly characterized, quality-controlled, manufacture-ready cryopreserved leukopaks. By collaborating with world-renowned organizations, we enable donor material collection and management that meets the highest standards. These partnerships enable us to offer therapy developers a reliable and consistent supply of top-tier leukapheresis starting material.

Our alliances include partnerships with NMDP BioTherapies and other prominent organizations, granting us access to a pool of over 7 million genetically diverse potential donors. Our established network guarantees compliance with regulatory standards and maintains the integrity of the donor material throughout the collection process.

Cryoport Systems supports the delivery of optimized, manufacture-ready cryopreserved leukopaks across the U.S. and Europe. Our global reach and strategic partnerships enable us to meet the demands of clinical trials and commercial manufacturing processes. By leveraging these collaborations, we ensure that our clients have access to the best possible starting material, supporting the advancement of cell and gene therapies worldwide.