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Frequently Asked Questions on Primary Cells

Frequently Asked Questions on Primary Cells

Find answers to frequently asked questions (FAQ) about ready-to-use fresh or cryopreserved cells from STEMCELL Technologies.

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General Information

Why use human primary cells from STEMCELL in your research?

STEMCELL offers a selection of ready-to-use fresh or cryopreserved cells, including mononuclear cells (MNCs), purified immune cells, or stem cells isolated from blood or bone marrow* to support your research. We ensure you receive ethically sourced, high-quality biological material and ship all our human primary cell products with a Certificate of Analysis (CoA) showing guaranteed quality control testing for cell count, viability, and purity. We help you get the cells you need, by meeting your requirements for custom cell collection or isolation, specific donors, cell characterization, and shipping, and by providing the option to reserve entire lots to pre-screen cells for your applications.

Learn more: Partner with the Right Human Primary Cell Supplier

*Due to government regulations, cord blood and bone marrow products may not be available in your region. Please contact us or your sales representative for the most up-to-date information on primary cell availability in your region.

Should I use cell lines or primary cells for my experiment?

STEMCELL recommends that you use primary cells for your experiments where possible. Human primary cells are increasingly recognized as an ideal model for your experiment—data obtained from in vitro assays or in vivo models using these cells have increased physiological relevance compared to those performed on cell lines. Primary cells are isolated directly from tissues, including blood and bone marrow, and are therefore more representative of the tissue being investigated than cell lines.

Learn more: Advantages of Primary Cells over Cell Lines

What are the advantages and disadvantages of using either fresh or frozen leukopaks?

Both fresh and frozen leukopaks are ideal starting materials for downstream cell isolation when large numbers of cells are required, reducing the time and reagents needed to process cells of interest. A couple of key considerations for deciding between using fresh or frozen leukopaks for your experiments are highlighted below:

  1. Experiment start date: Frozen leukopaks offer more flexibility on when you start your experiments. If needed, they may be stored at -135ºC or colder until you are ready to process the cells. In contrast, fresh leukopaks should be processed upon receipt for best results. If absolutely necessary, they may be stored at refrigeration temperature (2 - 8ºC) until you are ready to process the product; however, there is expected cell loss with extended storage after receipt. For data on this, please see Data and Publications on the product landing page.
  2. Downstream use of cells: Cells isolated from a frozen leukopak may be used for a variety of assays after thawing. However, it is not advised to re-cryopreserve and bank cells isolated from a frozen leukopak for later use. Cells tend to be sensitive post-thaw and a second freeze-thaw cycle typically results in high cell death. Fresh leukopaks, in contrast, are ideal for either immediate use or cryopreservation (banking) of isolated cell types for later experiments.

How are STEMCELL's primary cells validated?

STEMCELL’s primary cells are validated using our Quality Management System, which assesses cell count, viability, and purity. STEMCELL's Quality Management System is certified to ISO 13485:2016 Medical Devices and ISO 9001:2015.

Learn more: Partner with the Right Human Primary Cell Supplier

How can STEMCELL help me with my experiments?

STEMCELL offers a suite of products and services that help you get the results you need. Overcome challenges in your experimental procedures by engaging with our Contract Assay Services (CAS) or training programs and combining the power of STEMCELL media and reagents with the knowledge of our scientists and educators.

CAS is a contract research organization (CRO) established within STEMCELL that specializes in primary cell-based assays. CAS offers services such as the Colony-Forming Unit (CFU) assay for hematotoxicity testing, immunological assessment, and biopharmaceutical testing, as well as the development of custom assays for a variety of cell types.

Learn more: Contract Assay Services

If you would prefer to learn techniques to use yourself, STEMCELL's training programs offer comprehensive, theoretical, and hands-on training—customizable for your specific needs.

Explore: STEMCELL's Training Programs

What types of human primary cells can STEMCELL provide?

STEMCELL offers a selection of human primary cell products*, including:

Cryopreserved Human Peripheral Blood Products:

  • Peripheral blood mononuclear cells (PBMCs) isolated from normal donors (high-resolution HLA typing and CMV status available)
  • Isolated Cells: CD34+ cells, B cells, T cells, NK cells, DCs, monocytes, and other cell subsets available
  • PBMCs isolated from diseased-state donors diagnosed with: Crohn’s Disease, lupus, psoriasis, various cancer subtypes (e.g. prostate, pancreatic, ovarian cancer, etc.), and more
  • Leukopaks (collected in acid-citrate-dextrose solution A; ACDA)
  • Plasma
  • Serum
  • Human Platelet Lysate (hPL): fibrinogen-containing, fibrinogen-depleted, xeno-free, and GMP-compliant options are available

Cryopreserved Cord Blood Products*:

  • CD34+ cells from single or mixed donors
  • MNCs, T cells, B cells, NK cells, monocytes, and other cell subsets available
  • Plasma

Fresh Human Peripheral Blood Products:

  • Whole blood from normal donors (collected in ACDA, CP2D, EDTA, or Na Heparin)
  • Whole blood from cancer donors
  • Isolated cells (B cells, T cells, NK cells, monocytes, and other cell subsets available)
  • PBMCs
  • Leukopaks from normal donors (collected in ACDA)
  • Leukopaks from cancer donors
  • LRS Cones or LRS Chambers
  • Plasma
  • Serum

Learn more about STEMCELL’s human primary cell offerings: Primary Cells Overview

*Certain products are only available in select territories. Please contact your sales representative or our primary cells team directly for availability in your region.

What types of diseased cells does STEMCELL offer?

STEMCELL offers a broad range of both fresh and frozen diseased cells, including but not limited to:

  • Cryopreserved diseased peripheral blood products: PBMCs, serum, and plasma
  • Fresh diseased peripheral blood products: leukopaks and whole blood samples
  • Cells from patients diagnosed with: rheumatoid arthritis, ulcerative colitis, Crohn's Disease, COPD, lupus, osteoarthritis, celiac disease, psoriasis, diabetes type I, and diabetes type II, liquid/heme tumors, solid tumors, and various cancer subtypes (e.g. melanoma, liver, endometrial, and more)

View all diseased cell product offerings >

Diseased cell types are dependent on donor availability and regional restrictions. Please contact your sales representative or our primary cells team directly for availability in your region.

What custom primary cell products does STEMCELL offer?

Custom primary cell products include:

  • Rare or difficult-to-isolate hematopoietic cell types (normal and diseased, including cells from patients with autoimmune diseases, diabetes, asthma, cancer, etc.)
  • Cells that meet specific donor recruitment criteria
  • Collection obtained using alternative anticoagulants
  • Products in alternative size formats, e.g. bags, vial sizes, requested cell counts, etc.
  • Donor-matched collections for fresh and/or cryopreserved cells, e.g. whole blood, leukopaks, isolated cells, plasma, serum, etc. from the same donor

Learn more about our custom solutions for primary cell products or contact us directly for more information.

Does STEMCELL offer primary cells that are GMP-certified?

We do not currently offer GMP-certified cells. Our primary cell products are suitable for research purposes only and are not to be used as a starting material for cellular therapies.

Is STEMCELL compliant with the Human Tissue Act (HTA)?

The HTA 2004 regulates the use (including the removal, storage, and use of human tissue and cells) of human biological materials in the U.K. and is overseen by the HTA.

Our human primary cell products are collected in the U.S. or the U.K.. Cells sourced in the U.S. are collected using protocols and Informed Consent Forms (ICF) approved by an FDA (and HHS) registered Institutional Review Board (IRB) or equivalent agency. Cells sourced in the U.K. are collected using protocols and ICFs approved by an National Health Service (and Health Research Authority) Research Ethics Committee (REC) or equivalent agency.

We can provide IRB-approval and ICF documents, as well as a Quality and Compliance Statement to assist with your compliance needs. Please contact your regional sales representative or techsupport@stemcell.com for further information.

How does STEMCELL obtain primary cell products?

Donations for STEMCELL’s human primary cell products are performed in the United States and in the United Kingdom in compliance with applicable federal, state, and local laws, regulations, and guidance (for the United States) and consent forms and protocols approved by the Human Tissue Authority (for the United Kingdom). Cells are obtained from donors who are voluntarily participating in a donor program approved by an Institutional Review Board (IRB), the Food and Drug Administration (FDA), Research Ethics Committee (REC) or an equivalent regulatory authority. Donors are reasonably compensated for their time and effort during their donation, in accordance with FDA regulations or as approved by an IRB. Donors are aware that the cells may be used for research applications and have waived any rights generated from the research applications. Donors are protected by strict controls on personal identifiers and researchers cannot access any identifying information about donors.

For all products, with the exception of frozen cancer products*, donors are pre-screened for general health and viral status, including HIV-1, HIV-2, hepatitis B, and hepatitis C, according to our Donor Viral Screening Policy. Donors in the U.K. are additionally screened for HTLV I/II and syphilis

All products should be handled at Biosafety Level 2 (BSL-2) or higher, and universal handling precautions for biological samples should be used. Additional screening or analysis are available upon request. Customers purchasing primary cell products from STEMCELL acknowledge that they are required to treat all products as potential biohazard materials and waive STEMCELL of any liabilities from contaminations of infectious pathogens in these products.

Contact us for further information on the collection of human primary cells by STEMCELL.

*Due to factors related to the donor's condition, Infectious Disease Screening is not routinely conducted for frozen cancer biospecimens.

Where can I get additional product documentation, such as the Certificate of Analysis (CoA), Institutional Review Board (IRB)-approval, Informed Consent Forms (ICF), etc.?

The Certificate of Analysis (CoA) for your product can be requested by completing this form.

Any other documentation, such as IRB-approval forms, ICF, or other information about downstream usage can be provided upon request to your regional sales representative or the Product and Scientific Support team (techsupport@stemcell.com).

Can I place the cells on hold while I test them?

STEMCELL offers a flexible hold policy for primary cell products. You are welcome to place the products of interest on hold, whether it is a specific cell type or sample size, or products from a particular donor. We will hold these batches for you until you have completed your testing within the stipulated hold period (< 3 months). Holds can be extended if necessary for up to three months, completely free of charge. However, if you anticipate holding the cells beyond 3 months, a storage fee may apply, calculated as a recurring monthly charge based on the total hold value. Please refer to the terms and conditions and contact your local sales representative for more information on holds.

Does STEMCELL offer bulk discounts and price matching for human primary cells?

Bulk Pricing Discounts:

Volume Discounts: Large-volume orders may qualify for discounts. Please contact us for specific pricing tiers and discounts applicable to your order size.

Price Matching:

Competitive Pricing: If you find a lower price for the same human primary cells from another supplier, we will match that price, subject to verification.

Conditions: The competitor's product must be identical in terms of cell type, quality, and availability. The item must be in stock at the time the price match is requested. The price match request must be made at the time of purchase and submitted with a competitor quote.

Exclusions: Price matching excludes diseased primary cells product offerings and any promotional discounts, clearance items, and offers from licensed suppliers for all primary cell products. All price match requests are subject to approval. Please contact your sales representative or the primary cells team for more information.

Are STEMCELL primary cell products sterility-tested or guaranteed to be free from microbial contamination?

STEMCELL primary cells are carefully collected and manufactured using strict aseptic techniques to minimize contamination risk. While sterility testing is not required for product release, some lots are tested, and we screen cord blood samples for bacterial contamination.

If a product is ever found to be contaminated with bacteria, fungi, or yeast, we will replace it, provided proper controls and evidence confirm the cells as the source.

Note: Our primary cells are not tested for endotoxin, pyrogen, or mycoplasma.

Donor Information

What kind of donor information is available?

You can specify your preference for donor requirements, including, but not limited to, the following:

  • Age
  • Sex
  • Ethnicity
  • Weight
  • Height
  • Smoking status
  • HLA type
  • CVM status

Please note that some donor requests incur additional fees. Specific donor requirements such as HLA type, health information (medication, alcohol) or others may require new manufacturing or donor recruitment. Visit our Custom Solutions for Human Primary Cells page to learn more about how we can support your custom needs. To discuss further, please reach out to your sales representative or contact us directly.

How does STEMCELL collect donor demographic information?

STEMCELL collects donor demographic information ethically, using consent forms and protocols approved by either an Institutional Review Board (IRB), the Food and Drug Administration (FDA), the U.S. Department of Health and Human Services, and/or an equivalent regulatory authority. Donations are performed in the United States in compliance with applicable federal, state, and local laws, regulations, and guidance.

For ease of procurement, our Quality Assurance, Quality Control, and Regulatory Affairs departments are ready to assist you with any necessary documentation to meet specific institutional supplier approval requirements.

Contact us for further information on the collection of donor demographics.

What is STEMCELL's donor viral screening policy?

Bone Marrow and Peripheral Blood Products: Normal Leukopaks, Whole Blood, Purified Cells, and LRS Cones - Fresh Products*:

Donors are screened for HIV-1, HIV-2, hepatitis B, and hepatitis C. Donors in the UK are also screened for HTLV I/II and syphilis.

If the donor has been screened within 90 days prior to donation and the results are negative, the product will be shipped with the negative test result and date of most recent viral testing on the Certificate of Analysis (CoA). If the donor has not been screened within 90 days prior to collection, a test sample will be taken at the time of collection and the product will be shipped before the screening results are available. In the event that a test result is positive, the customer will be contacted as soon as possible (usually within 2 - 4 business days from the time of shipment, and within 4 - 7 business days in the case of fresh LRS cones).

Mobilized Peripheral Blood Leukopaks - Fresh Products*:

For fresh mobilized leukopaks donors are screened for HIV-1, HIV-2, hepatitis B, hepatitis C, HTLV-I/-II, Syphilis, and WNV.

If the donor has been screened within 90 days prior to donation and the results are negative, the product will be shipped with the negative test result and date of most recent viral testing on the Certificate of Analysis (CoA). If the donor has not been screened within 90 days prior to collection, a test sample will be taken at the time of collection and the product will be shipped before the screening results are available. In the event that a test result is positive, the customer will be contacted as soon as possible (usually within 2 - 4 business days from the time of shipment).

Normal Leukopaks, Whole Blood, Purified Cells, and Bone Marrow - Cryopreserved Products*:

Donors are screened for HIV-1, HIV-2, hepatitis B, and hepatitis C. Donors in the UK are also screened for HTLV I/II and syphilis. If the donor has tested negative within 90 days prior to donation, the product will be shipped with the negative test result and date of the most recent viral testing on the CoA.

Cord Blood Products - Cryopreserved Products*:

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