FDA-REGISTERED, GMP-COMPLIANT CLEAN ROOMS
Adjacent FDA-registered collection and processing facilities minimizes time between collection and cryopreservation within GMP-compliant clean rooms to deliver superior post-thaw TNC and cell viability.
SCALABLE, FLEXIBLE SUPPLY CHAIN
Cryopreserved cells provide timeline flexibility without compromising quality. Continuous and assured supply chain can support scalability requirements.
Utilizing an optimized protocol and GMP-compliant controlled-rate freezers preserves cellular functionality and high post-thaw recovery and viability.
DEPENDABLE COLD CHAIN LOGISTICS
AllCells utilizes validated shipping containers (Aerosafe and CryoPort) for dependable end-to-end
GMP-Compliant 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-compliant 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.
In-Stock GMP-Compliant Cryopreserved Leukopaks
While some cell and gene therapy programs require unique donor specifications, many programs require standardized GMP-compliant Cryopreserved Leukopak products. AllCells’ In-Stock GMP-compliant 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
Maintain Flexibility in Your Workflow Without Compromising Quality
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.
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-compliant Leukopaks are cryopreserved in CryoStor® CS10—a GMP-grade 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-Compliant 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-compliant 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-compliant 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.
Cryopreserved Leukopak Product Portfolio
AllCells offers GMP-Compliant Cryopreserved Leukopaks in standard made-to-stock or custom formats. Customizations are driven by a client’s program-specific requirements and can include (but are not limited to):
A variety of aseptic division formats:
- By cell volume or cell count
- Have part of the collection fresh and part of it cryopreserved
- Delivery to different geographical destinations
Alternative cryopreservation formulations, packaging formats and more
All GMP-Compliant Cryopreserved Leukopaks are quality controlled for cell count and viability (pre-cryopreservation) using a validated AO/PI protocol and undergo extensive quality review prior to batch release to ensure quality and regulatory compliance with GMP are met. Each product meets the specifications listed below.
|Standard (CG, LP, CR, Solo, 2.5-3.0B)||Custom|
|Donor Criteria||Donors meet FDA’s CFR 1271 infectious disease panel testing, DHQ and Physical Exam||Standard or Custom|
|Testing timeline||Pre-screen performed ≤30 days before collection; also test on day of collection||Standard or Custom|
|Format||Origen CS250 bag with 70 ± 5 mL. Minimum 3 bags per lot.||Standard or Custom|
|Pre-Freeze Cell Viability||≥ 90%||≥ 90%|
|Pre-cryopreservation TNC count per bag||≥ 2.5 Billion cells||Standard or Custom|
|Sterility USP <71>||No Growth||No Growth|
|Documentation||Certificate of Analysis, Summary of Records, Immunophenotype Report, and Sysmex 5-Part Differential Report||Certificate of Analysis, Summary of Records, Immunophenotype Report, and Sysmex 5-Part Differential Report, and additional custom needs|
|Shipping||Validated shipping container||Validated shipping container|
A Certificate of Analysis (CoA) is provided with every GMP-Complaint Clinical Grade Cryopreserved Leukopak order. Looking for more information on AllCells GMP products and processes? Check out our Webinar, The Importance of Good Manufacturing Practices (GMP) Raw Material Suppliers and our Thawing Protocol in our Resources section.