IntegriCell™: Extending Cell Viability with Manufacture-ready Cryopreserved Leukopaks

IntegriCell™: Extending CellViabilitywithManufacture-readyCryopreserved Leukopaks

During the COVID-19 pandemic, the restrictions on transportation and travel negatively impacted patients' access to life-saving treatments and support. According to NMDP(1), a global leader dedicated to facilitating allogeneic stem cell transplants, the lack of availability of fresh apheresis material greatly affected patients needing transplants during this time. This need necessitated the use of cryopreserved apheresis (or leukopaks) for stem cell and bone marrow products. However, many stem cell transplant programs lacked the capacity, resources, or expertise to shift from a fresh to cryopreserved product.

While the COVID-19 pandemic has subsided, the use of cryopreservation to preserve starting material viability is still in use in the stem cell transplant setting and becoming the new standard in the cell therapy industry. As an evolving provider of solutions for this market, Cryoport Systems' IntegriCell™ cryopreservation services aim to meet the needs of today's developers with clinics and patients in mind. Integrated into our existing platform of supply chain solutions, the IntegriCell™ model supports the cryopreservation and delivery of manufacture-ready cryopreserved leukopaks to manufacturing facilities safely and securely.

The Case for Cryopreservation

While the COVID-19 pandemic exemplified almost in real-time the reliability of using cryopreserved apheresis material for product manufacturing, studies report the consistent nature of creating products from fresh versus cryopreserved apheresis in a laboratory setting. In a study published by ASGCT's Molecular Therapy(2), researchers set out to determine the viability of in vivo administered fresh CAR T cell products versus (cryopreserved) thawed CAR T cell products. The results indicated "similar product persistence and positive clinical outcomes" between the fresh product and the (cryopreserved) thawed product.

Additionally, data from a study published in Cell & Gene Therapy Insightsdemonstratesthe use case of cryopreservation for the extension of shelf life for apheresis material. In it, researchers collected donor leukapheresis samples and cryopreserved the products. After evaluating the materials for the recovery and viability of white blood cell (WBC) and CD14+ cells 24 hours post-collection, researchers found that the cryopreserved material maintained similar viability and WBC in comparison to fresh products, and the total viable CD14+ cell ranged from 78% to 94%. Collectively, the study's outcome labeled cryopreservation as a viable option for maintaining the overall quality of the starting material for the use of manufacturing cell therapies."(3)

IntegriCell's Industry-leading Capabilities

Cryoport Systems' IntegriCell™ cryopreservation services are designed to offer unparalleled support in ensuring the safety, quality, consistency, and viability of critical manufacture-ready cryopreserved leukopaks needed to treat an increasing number of patients with today's most advanced cell therapies. Our standardized cryopreservation protocols and use of innovative technologies will support the biopharmaceutical supply chain from research stages to clinical and commercial operations plus process development to manufacturing. Our services plan to provide the optimization of cellular quality within a 24-hour ideal window post-collection for improved consistency and overall reduction in product variability.

IntegriCell™ cryopreservation is being built on a foundation of compliance to support the critical nature of these therapies. Our cryopreservation as a service will help to enable advanced therapeutic development through:

• Standardization of cryopreservation protocols performed by experienced IntegriCell™ teams.
• Improved manufacturing slot utilization to assist with efficient and accurate administration scheduling.
• Global clinical trial coverage through our US and European footprint.

An Entire Platform of Supply Chain Support

The limited product stability of fresh apheresis material places a major strain on supply chains, limits manufacturing flexibility, and can significantly impact the overall product quality(4). IntegriCell™ is soon launching to overcome these challenges through the cryopreservation of leukapheresis ideally within 24 hours post-collection, extending product viability to meet and maintain established timelines. As a part of our industry-leading platform of supply chain solutions, IntegriCell™ is designed to leverage our supply chain excellence to provide cryopreservation services to allogeneic and autologous cellular therapy developers and deliver the consistent and manufacture-ready cryopreserved leukopaks to manufacturing facilities worldwide.

Our first IntegriCell™ facility is co-located with our Global Supply Chain Center(GSSC) in Houston, TX. The GSSC also houses our BioServices (biostorage, kit production, drug packaging, and labeling) and logistics capabilities. A single location for these three services means that our team can streamline both cryopreservation, storage, and logistics under one roof to reduce the legs necessary to collect and deliver patients' vital materials. With our temperature-controlled supply chain offerings plus our IntegriCell™ capabilities, Cryoport Systems leverages our end-to-end supply chain solutions to support cost optimization, improve system efficiencies, and mitigate risk from starting collection to final product.

Cryoport Systems' IntegriCell cryopreservation services will support clinical trials on a global scale to ensure the delivery of critical, high quality, manufacture-ready cryopreserved leukopaks. For more information, explore our IntegriCell™ webpageon our website.

1. David. (2022, March). Cryopreservation relieves access issues for patients needing HCT during the COVID-19 pandemic. Be the Match Clinical. https://bethematchclinical.org/medical-education-and-research/browse-research/cryopreservation-relieves-access-issues-for-patients-needing-hct-during-the-covid-19-pandemic/
2. Panch, S., & Srivastava, S. (2019, May 30). Effect of Cryopreservation on Autologous Chimeric Antigen Receptor T Cell Characteristics [Review of Effect of Cryopreservation on Autologous Chimeric Antigen Receptor T Cell Characteristics]. ASGCT. https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(19)30249-7
3. Clarke, D., & Smith, D. (2019). Managing starting material stability to maximize manufacturing flexibility and downstream efficiency. Cell & Gene Therapy Insights, 5(2), 303-314. https://doi.org/10.18609/cgti.2019.033
4. Clarke, D., & Lawrence, N. (2019). Crypopreservation of the clinical apheresis starting material maintains quality and offers options to extend stability. Cytotherapy, 21(5), S39-S40. https://doi.org/10.1016/j.jcyt.2019.03.377

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