StemExpress' Peripheral Blood Leukopaks provide enriched peripheral blood mononuclear cells (PBMCs) with low granulocyte and red blood cells. This highly enriched PBMC fraction requires minimal downstream processing (i.e. Ficoll) and can be used directly for isolating high yields of immune cells, such as CD4+ T cells, CD8+ T cells, CD19+ B cells, monocytes, and other immune cells. High cell yields allow researchers greater reproducibility of experiments from a single donor (minimizing donor-to-donor variation), a decrease in same cell variability, and scalability of experiments. In addition, up to 12 Leukopaks can be collected from the same donor in a given year, providing an ample amount of PBMCs for large-scale experiments and research studies.
Leukopaks are sent out on the same day or frozen immediately to ensure a highly viable product.
- 1x1010TNCs/full bag
- Highly-enriched PBMCs
- ≥95% viability (fresh)
- HBV, HCV, HIV negative
- IRB approved
StemExpress Donors
Access to a diverse donor pool is key to the successful development of new therapeutics. With 6 locations nationwide, the StemExpress donor pool is one of the largest HLA-typed and most characterized in the industry. All collection centers are FDA registered, and boast on-site state-of-the-art laboratories, providing an end-to-end service whereby cells are processed, isolated, and cryopreserved or shipped out fresh immediately after collection from a donor.
Choosing a complete partner in research starts with a reliable donor base - from demographic diversity and targeted recruitment to recallability and retention. StemExpress focuses on finding the right donors for a project, with customizable IRB consents and downstream protocols to fit the client's needs. Once a donor is fit to a project, StemExpress works diligently to ensure recallability, with expert donor retention strategies in place.
Donors are an integral part of clinical and preclinical project planning. Knowing how accessible your target donors are, and your ability to reliably recall them can indicate future success and scalability of a project. StemExpress strategically maps out each step in the donor/research process, handling logistics ranging from screening for target genetics, to customizing IRB consents.
In addition to managing donor specifications, StemExpress provides access to a coast-to-coast donor network, with a wide, demographically diverse footprint. Given our far-ranging national reach, StemExpress is able to mitigate supply risks caused by natural disasters, COVID closures, and unforeseen shipping delays.
Our recruitment team seeks out the best donors by engaging with our communities through local businesses, fairs, restaurants, colleges, health and wellness expos, gyms, and donor drives.
- Broad and/or targeted donor recruitment efforts across 5 states
- Collections take place in safe, clean, private collection rooms
- Highly effective donor retention protocols
- Strict guidelines and quality standards - ensuring consistent, compliant, viable, and pure cells with guaranteed counts
- Local same-day delivery within 150 miles
- Recallable and repeat donors
- Customizable donor/patient questionnaire
- Specific donor demographics (age, weight, ethnicity, etc.)
- Donor lifestyle characteristics (BMI, smoker/non-smoker, etc.)
- Medical history (allergies, medications, etc.)
- HLA, RhD, and ABO typing available
- Additional infectious disease screening (CMV, etc.)
- Global reach & delivery
- Good Tissue Practices (GTP)
- All sites FDA Registered
Customization
- Fresh or Frozen
- Raw material or isolated cells
- Customized IRB or ICF
- Matched cell types and custom cell counts
- Donor demographics/characteristics
- Shipping, packaging, courier
- Additional infectious disease screening (CMV, etc.)
- Much more....
Apheresis
Apheresis is a critical starting point for all research projects, setting the standard for downstream project success through high-quality starting material. StemExpress is a leading provider of apheresis products, with an expansive footprint through our coast-to-coast cell collection centers and unprecedented access to demographically diverse donors. Our expertly trained technicians ensure every draw is GMP compliant, and subsequently shipped out fresh or cryopreserved on-site.
StemExpress collections take place in clean, private, individual collection rooms ensuring a controlled and comfortable experience for donors. Leukopaks are collected in a highly regulated FDA-approved closed system Spectra Optia® Apheresis machine using continuous auditing.
Apheresis collections can be sent to the researcher as a fresh product or sent to the StemExpress lab to be further isolated, or manufactured through custom protocols under the research partner’s or hospital’s regulatory compliance.
Fresh Leukopaks
Leukopaks are collected from healthy IRB consented donors, tested negative for HBV, HCV, and HIV, using the Spectra Optia® Apheresis System, where cell-rich mononuclear cells are extracted using a continuous flow system directly into a sterile collection bag containing anticoagulant. Up to 12 Leukopak collections can be performed on the same donor in a given year, providing an ample amount of PBMCs for large-scale experiments and research studies. Additionally, 200-300mL of plasma can be collected at the time of the donor draw.
The following are mean percentages of cell populations in a Leukopak:
- T cells – 55%
- Monocytes – 27%
- B cells – 9%
- NK cells – 8%
- CD34+ stem cells – 0.1%
- Granulocytes – 2.4%
We do not guarantee the percentage of cell populations in a Leukopak, as they can vary from donor to donor.
Cells were obtained using Institutional Review Board (IRB) approved consent forms and protocols.
Frozen Leukopaks
Frozen Leukopaks are collected from IRB consented healthy donors at our FDA-registered Stem Cell Collection Center. Using the Spectra Optia® Apheresis System, cell-rich peripheral blood mononuclear cells (PBMCs) are extracted using a continuous flow centrifugation system directly into a sterile collection bag containing an anticoagulant. Besides the PBMCs, which consist of lymphocytes and monocytes, each Leukopak will also contain minimal amounts of granulocytes and red blood cells.
The following are mean percentages of cell populations for a single donor Leukopak prior to cryopreservation:
- T cells – 55%
- Monocytes – 27%
- B cells – 9%
- NK cells – 8%
- CD34+ stem cells – 0.1%
- Granulocytes – 2.4%
We do not guarantee the percentage of cell populations in a Leukopak, as they can vary from donor to donor.
Once collected, Leukopaks are quickly frozen in a medium containing a cryoprotective agent and using a controlled rate freezer to ensure maximum viability.
Total nucleated cell (TNC) counts and viability testing are performed prior to cryopreservation. For optimal cell recovery and viability, we recommend following our “Thawing Protocol” found under the Technical Resources tab. Deviations from this protocol can compromise viability and cell recovery.
For global shipments, we highly recommend shipping Frozen Leukopaks in an LN2 cryoshipper to maintain proper temperatures for the duration of the transit time. Upon arrival, Frozen Leukopaks should be stored in the vapor phase of liquid nitrogen or thawed immediately for use.
Human Mobilized Peripheral Blood Leukopaks
Human Mobilized Peripheral Blood Leukopaks are collected from healthy IRB consented donors that are injected with granulite stimulating agent and immunostimulant, or a combination of the two which increases circulating leukocytes and stimulates the bone marrow to produce a large number of hematopoietic and progenitor stem cells and mobilizes these cells into the bloodstream, allowing for enriched CD34+ hematopoietic stem cells from a single donor as compared to traditional Leukopaks. Collecting CD34+ stem cells from a single donor eliminates donor-to-donor variation, allows scalability of stem cell studies, and decreases same cell variability. Mobilized Leukopaks are ideal for stem cell studies relating to regenerative medicine, immunotherapy, and transplant therapy.
Mobilized Leukopaks are collected from healthy IRB consented donors that are injected with a combination of two expert grade stimulating factors the day before collection, which stimulates the bone marrow to produce hematopoietic stem cells and mobilizes them into the bloodstream, prior to first day of collection. Mobilized mononuclear cells are collected by a trained technician using the Spectra Optia® Apheresis System one and two days post injection. After collection, mobilized Leukopaks are checked by flow analysis to verify the percentage of granulocytes, mononuclear cells, CD34+ cells, and cell viability.
Cells were obtained using Institutional Review Board (IRB) approved consent forms and protocols.
Clinical
Clinical Fresh Leukopak products contain a high concentration of all major lymphocyte populations (T Cells, B Cells, NK Cells, and monocytes) and are GTP/GMP compliant products for cell-based therapy as well as used as the starting material for further manufacturing in allogeneic cell therapies. Our donors follow FDA 21 CFR 1271 guidelines and our productions follow enhanced quality training and are subjected to CMNC protocol in our FDA-registered collection centers. Depending on the unique requirements and expectations, StemExpress can customize the donor selection process, infectious disease screening and screening timepoints along with the collection to meet clients needs as well as international regulatory requirements.
StemExpress Cell Processing and Isolation
Obtaining a specific primary cell population from human tissue can be time-consuming and costly. If not done quickly and properly, cell viability and recovery can be compromised, creating new challenges to overcome and delays in your research.
To provide high-quality cells to scientists and keep their research moving forward, each StemExpress Stem Cell Collection Center houses an on-site state-of-the-art laboratory, providing an end-to-end service whereby cells are processed, isolated, and cryopreserved or shipped out fresh immediately after collection from a donor. This end-to-end service provides accountability and traceability for each product that leaves our facilities. Additionally, all methods involved in tissue collection, cell processing, cell isolation, and analysis follow strict guidelines and quality standards ensuring consistent, compliant, viable, and pure cells with guaranteed cell counts.
We work with each client to make sure they receive the right primary cells for their project. Therefore, each step of the process is customizable to suit the specific needs of the client, starting with the right donor with specific attributes to isolating and analyzing a specialized cell type.
StemExpress Equipment Validation
StemExpress offers on-site equipment validation support for our clients looking to verify that their devices meet FDA and GMP standards. Our testing process ensures full compliance and optimization of lab operations prior to product distribution. Bring your device to our state-of-the-art labs to ascertain that your equipment performs all of its intended functions with resolution and fidelity.
