GMP Cryopreserved Leukopaks

Leukopaks, collected from peripheral blood from a single donor, are enriched in mononuclear cells (MNCs) containing immunologically important lymphocyte populations like T cells, B cells, NK cells and monocytes. Many of these subpopulations are important starting materials for downstream processing in cell and gene therapy programs like CAR-T immunotherapy. While the viability characteristics of fresh Leukopaks can be maintained and extended over a period of several days, the decline in quality is inevitable, which can negatively impact experimental workflows, costing time, money and resources.

AllCells’ GMP Cryopreserved Leukopak offers comparable quality, consistency and regulatory compliance of fresh GMP Leukopaks with the advantages of extended shelf life and stability. It offers researchers reliable and flexible access to high-quality starting materials no matter the timeline.

The stability of freshly isolated leukopaks can be prolonged when held at 2-8C for up to 5 days compared to controlled room temperature (CRT), where product quality degrades rapidly within 72 hours. Cryopreservation at the peak of cell viability and functionality mitigates the loss of product quality over time.

While some cell and gene therapy programs require unique donor specifications, many programs require standardized GMP Cryopreserved Leukopak products. AllCells’ In-Stock GMP Cryopreserved Leukopak is an industry first, ready-to-ship, off-the-shelf clinical-grade raw materials that provide researchers with rapid access to high-quality cells for the development and manufacture of therapeutics.

Donors are regularly screened to ensure eligibility. The quality and functionality is optimally preserved through optimized cryopreservation processes to facilitate success in downstream cell and gene therapy workflows.

Healthy IRB-consented donors must meet baseline requirements for clinical donation including:

• Research Use Only Qualification Requirements
• AABB + Zika Health Questionnaire
• Physical Exam
• Viral Testing in compliance with 21 CFR 1271 + CDC, NIH, AABB
• Clinical-Grade Specific Protocols/Informed Consent Forms

Cryopreservation at the peak of viability and functionality preserves cell phenotypes and allows cells to be stored for use at a later time point with minimal loss in the viability and potency. Stored properly, researchers have access to high-quality source material without the risks associated with fresh Leukopak collections that can be impacted by donor scheduling delays, cancellations or courier-related issues. Advantages of cryopreservation include simplified logistics and timeline flexibility.

AllCells’ optimized cryopreservation protocols deliver high cell viability of important lymphocyte populations with low-granulocyte contamination. In studies comparing the average % viability and viable cell counts between fresh and post-thaw cryopreserved Leukopaks, no statistically significant differences were observed. Additionally, cryopreservation did not alter the proportion of mononuclear subpopulations (T cells, B cells, NK cells and monocytes) in comparative assessments.

Optimized Cryopreservation

Peripheral blood is collected from IRB-consented donors as per 21 CFR 1271 regulatory guidelines using the continuous flow Spectra Optia® Apheresis System directly into ACD-A anticoagulant at AllCells’ FDA-registered, IRB-approved collection facilities located in Alameda, California and Quincy, Massachusetts. Fresh leukapheresis material is immediately processed in adjacent processing facilities to minimize the time between collection and cryopreservation, which is known to impact post-thaw viability and recovery.

GMP Leukopaks are cryopreserved in CryoStor^® CS10—a GMP cryopreservation medium—using state-of-the-art conduction-cooled controlled rate freezers. The controlled cooling of the unit is gentle on cells and freezes cells uniformly for maximum viability and consistency. All cryopreservation steps occur within class ISO 7 cleanroom (with grade A and B zones) according to a proprietary and optimized Master Batch Record (MBR). The cleanroom is equipped with state-of-the-art instrumentation and employs a robust environmental monitoring (EM) program to ensure control and compliance of the aseptic conditions during manufacturing operations. GMP Cryopreserved Leukopaks undergo extensive quality review prior to batch release to ensure the highest quality standards are met and in additional compliance with GMP requirements for downstream applications for cell-based products.

Reliable Cold Chain Logistics

AllCells ships GMP Cryopreserved Leukopaks using validated shipping containers (Aerosafe and CryoPort) to ensure product integrity during transit. These shippers can maintain temperatures of ≤ -150°C for up to 10 days eliminating temperature excursions and risk of product degradation.

AllCells has removed the complex logistical and technical challenges, through its immediate cell processing, state-of-the-art cryopreservation protocols and dependable cold chain logistics to safeguard product quality. Having a reliable, scalable and secure GMP supply chain to meet the timeline and volume requirements of cell and gene therapy workflows assures downstream manufacturing success and rapid movement through the clinical pipeline. AllCells has a trusted reputation in the industry backed by a knowledgeable team and extensive industry know-how to help researchers navigate their workflows with ease.