What is a Leukopak?
A leukopak is an enriched apheresis product collected via leukapheresis, the act of extracting white blood cells (WBCs) from the peripheral blood. Leukopaks contain a high concentration of mononuclear cells (PBMCs) – which consists of T cells, B cells, NK cells, and monocytes. As shown below, WBC concentration is significantly higher in a leukopak (mean of 38.48 x 106 WBCs/mL) than whole blood (mean of 6.48 x 106 WBCs/mL). Additionally, red blood cell (RBC) concentration is significantly lower in a leukopak with a mean of 0.43 WBC for every RBC (about 1 WBC for every 2 RBC), whereas in a whole blood unit, it is a mean of 0.001 WBC for every RBC (about 1 WBC for every 1,000 RBCs). Similarly, leukopak purity and quality when compared to a buffy coat is far superior typically containing 20 times higher mononuclear cell content. PBMCs are highly prized for their use in immunotherapy research, cell therapy process development, and clinically. Therefore, leukopaks have become the starting material of choice for cell therapy research and drug development.
|White Blood Cell Concentration||White Blood Cell to Red Blood Cell Ratio
Leukopaks are collected at HemaCare’s FDA-registered collection center from healthy human donors who have consented under an IRB-approved protocol. This mononuclear cell-rich leukapheresis product is extracted using continuous flow centrifugal technology (Spectra Optia® apheresis system) directly into a sterile collection bag containing ACD-A anticoagulant with IQ, OQ, and PQ specifications.
Leukopaks play a critical role in the discovery, development, and manufacture of life-saving therapies. HemaCare can support your project from research through commercialization. When buying leukopaks, we suggest you review the different options below to decide which leukopak type is best for your research: fresh or cryopreserved research use (HemaPrime™) or GMP-compliant (GMPrime™) leukopaks.
A high-quality leukopak is a perfect balance of purity and yield. Achieving this balance requires not only apheresis expertise, but also a commitment to donor management. With donor nurturing and dietary guidance, we can maximize the potential quality of leukopaks from donors. However, even high-quality leukopaks are variable in terms of yield. Donor-to-donor variability is inherent and often unpredictable. This natural variability, however, will definitely be present in a patient population and must be accepted and accounted for during process development. Figure A demonstrates this natural variability across a sampling of 2,490 donors collected by HemaCare in our donor facility. The mean WBC yield of this analysis is 12.7 x 109 cells/donor, but the distribution of normal WBC yield is quite broad.
|Figure A||Figure B|
Although donor-to-donor variability certainly exists, with proper training, adherence to best practices, and standardization, collection-to-collection variability can be minimized. One strategy to minimize variability for certain applications is to utilize recallable donors. Figure B demonstrates the relative consistency of CD4+ cellular populations collected from recallable, reliable donors at multiple timepoints.
To gain a better understanding of the amount of variability apheresis centers encounter on a regular basis, review our in-depth analysis of a representative sample of our fresh leukopak collections drawn from healthy donors.
Simplify Complex Logistics with Cryopreserved Leukopaks
Planning and coordinating activities throughout the discovery and development continuum can be complicated, particularly when consistent high-quality human raw materials are required. With HemaCare’s unique cryopreserved leukopak, easily ship, bank, and store your materials to simplify complex logistics and planning while preserving quality and viability for downstream processing.
|Starting Material Management||Quality and Viability Preservation||Shipping Logistics|
|Simplify donor management and collection||Maintain product quality and viability||Ensure product integrity and consistency|
|Downstream Processing Consistency||Staff and Project Scheduling||Supply Allocation
|Store and maintain quality and viability until you are ready to process||Schedule processing events according to your timeline||Plan and manage materials required for processing|
Which format is right for you?
|Format||Viability||Recovery||Consistency||Long Haul Shipping||Flexibility
(Supply Allocation, Scheduling)
|Fresh||★ ★ ★||★ ★ ★||★ ★ ☆||★ ☆ ☆||★ ☆ ☆|
|Cryopreserved||★ ★ ★||★ ★ ☆||★ ★ ★||★ ★ ★||★ ★ ★|
A Cryopreserved Leukopak for Every Stage of Research
Depending on your stage of discovery, you may have specific considerations which affect the type and specifications of the leukopak needed. For early stages, maximum recovery of specific cellular components is of primary concern. The presence of granulocytes can negatively impact the consistent recovery of cells of interest within a cryopreserved leukopak as well as the stability and functionality of those cellular subcomponents. Granulocytes are poorly cryopreserved and can release DNA and lysosomal enzymes after freezing and thawing leading to clumping and loss of cell viability. Granulocyte contamination has been associated with the reduction of cell counts within MNCs, inhibition of T cell proliferation and activation, as well as the loss of regulatory T cells integrity. Controlling granulocyte contamination during apheresis collection and cryopreservation is critical in ensuring a consistent, stable, and functional leukopak.
Conversely, later stages of development require that materials be truly indicative of the population as a whole as these process development steps will ultimately be translated to the clinic and to patients. Testing must take into account variability as patient material will be highly variable. Therefore, for these later stages of development, a product which is uncontrolled for variability may be the most desirable.
Do you require consistency or variability in your cryopreserved leukopak?
|Controlled for Granulocytes||<15%||<15%||<15%||<15%||Variable|
|Cell Count||2-2.5 x 109||4-5 x 109||8-10 x 109||12-15 x 109||Variable|
|Number of Bags||1||2||4||6||Variable|
|Potential Use||R&D||R&D||R&D||R&D||Process Development|
Advancing Your Discovery to the Clinic with GMPrime Leukopaks
GMP cells are required to meet the regulatory guidelines for quality, safety, and efficacy of cell therapy starting materials for clinical trial and commercial use. The key to a seamless transition from research use to GMP-compliant products is establishing a solid partnership with suppliers that will be able to anticipate company sourcing needs when it comes time to begin product scale up.
At HemaCare, HemaPrime (RUO) and GMPrime (GMP-compliant) leukopaks are collected, processed, and validated following consistent procedures, eliminating most external sources of variability and leaving only those associated with the donor. The primary difference between the two is the level of quality management systems oversight and the extensive documentation that accompanies the GMPrime leukopak. As a result, partnering with HemaCare early on can streamline and expedite your transition from preclinical to clinical development, while ensuring a consistent, high-quality product throughout the development process.
Do you need research use only or clinical-grade cellular material?
|HemaPrime (RUO)||GMPrime (GMP-compliant)|
|Flexibility||★ ★ ★||★ ☆ ☆|
|Price and Availability||★ ★ ★||★ ☆ ☆|
|Cryopreserved and Fresh Formats||★ ★ ★||★ ★ ★|
|Consistent Process; Streamlines Transition||★ ★ ★||★ ★ ★|
|QA Oversight and Documentation||★ ☆ ☆||★ ★ ★|
|21 CFR Part 1271 Compliant||☆ ☆ ☆||★ ★ ★|
|Environmental and Biosafety Monitoring||★ ☆ ☆||★ ★ ★|