FAQs on Human Pluripotent Stem Cell Characterization and Banking Services

Ensuring the quality of your human pluripotent stem cell (hPSC) lines and generating a well-characterized hPSC master cell bank can be time consuming. Characterize your hPSCs and generate master cell banks quickly and reliably using pluripotent stem cell characterization and banking services from STEMCELL Technologies, offered in collaboration with WiCell®.

On this page, you can find answers to frequently asked questions (FAQs) about our hPSC characterization and banking services.

General FAQs

What countries are these services available in?

At this time, the hPSC characterization and banking services are only available in the United States. For customers outside of the United States, please contact Customer Service.

Can I purchase individual hPSC characterization assays from the bundle?

At this time, characterization services are only offered as a bundle. For individual assay options, please contact WiCell® at info@wicell.org.

How much do the services cost?

Up-to-date pricing can be obtained from your local STEMCELL representative or Customer Service.

What types of cells are accepted?

At this time, only human induced pluripotent stem cells (hiPSCs) are accepted for banking. However, both human embryonic stem cells (hESCs) and hiPSCs are accepted for characterization. For banking human embryonic stem cells, please contact WiCell® at info@wicell.org.

How do I order the services?

Request a quote from your STEMCELL sales representative or by contacting info@stemcell.com. You can find your sales representative by contacting info@stemcell.com. After reviewing your quote, submit a Sample Submission Form, which can be previewed here.

What documentation or agreements are required prior to service?

A signed quote will be needed to initiate the services. STEMCELL will also require documentation to support that you have permission to use the human biological material for these services (e.g. a copy of the Informed Consent Form provided to subjects at the time of sample collection).

Who do I contact if I have questions about my order?

Contact either the sales representative who provided the quote or Customer Service.

Will any unused samples be returned?

There will be no return of samples for the characterization service; if a cell bank is created, any unused samples will be returned with the cell bank.

How has STEMCELL qualified this third party to perform this service?

WiCell® is a recognized leader in the world of PSC characterization and banking. STEMCELL maintains a stringent supplier qualification, selection, and management process.


hPSC Characterization

What assays and readouts are included with the hPSC characterization service?

There are seven different parameters that are reported on for the characterization service:

  • Post-thaw viability
  • Identity (STR analysis)
  • Undifferentiated cell marker expression (OCT4, SSEA4, SSEA3, TRA-1-60, TRA-1-81 and SSEA1)
  • Karyotype (20-cell analysis)
  • SNP microarray
  • Sterility (mycoplasma)
  • Pluripotency (directed differentiation analyzed by flow cytometry)

What assays and readouts are included with the hPSC banking and characterization service?

The assays and readouts performed on a cell bank that is generated as part of the service includes all of the assays listed above for the characterization service. Sterility testing by a direct inoculation method is also included.

Can I have my hPSC sample tested for sterility?

While both mycoplasma and sterility testing by direct inoculation method are performed on a hPSC bank that is generated for a customer, sterility testing is currently not included in the bundle of hPSC characterization assays; only mycoplasma testing is performed on these samples. Sterility testing is highly dependent on the banking process, and with this being done outside of the service, there can be no guarantees of the assay's validity.

What is the turnaround time for characterization services?

Reports will be accessible in 11 - 15 weeks from the time of sample receipt.

What specific information will be provided within the hPSC characterization report?

The report provides a summary of results, along with information on individual assays performed on the submitted sample.

What information does WiCell® or STEMCELL retain?

STEMCELL Technologies retains a copy of the results from each assay for at least 5 years. WiCell® Cytogenetics Laboratory also keeps all information regarding customer samples, such as cell type, passage, type of media used to culture the cells, and the final test results and analysis for at least 5 years.

Who should I contact with questions about the hPSC characterization results?

Please contact your local STEMCELL sales representative.

How will I receive my hPSC characterization test results?

The results from your cell line(s) will be provided to you through our secure file-sharing system, ShareFile. Please consult the following document for details on how to access your reports.

How do I interpret the karyotype results?

View this sample Chromosome Analysis Report to learn how to interpret your karyotype results.

What is the significance of a recurrent abnormality?

Unexpected karyotype abnormalities pose potential risks to reproducibility and validity of scientific research. Karyotypic abnormalities that arise during the culture of hPSCs are similar to those observed in human cancers and can affect hPSC behaviour, including increased growth capacity, resistance to cell death, and also differentiation potential. Please follow this link for more information on recurrent karyotypic abnormalities. Additional information on hPSC genomic integrity and stability can be found here. If you have further questions, please contact your local STEMCELL representative.

What is a non-clonal finding on a chromosome analysis report?

The ISCN (International System for Human Cytogenomic Nomenclature) defines a clone as two or more cells that exhibit the same whole chromosome gain or structural change. If the change is a whole chromosome loss, then at least three cells must show the loss for it to be considered clonal. Non-clonal findings are changes that do not meet these requirements (typically single-cell findings).

The reason for these standards is that the preparation of the metaphase spreads is subject to a certain amount of technical artifacts (e.g. chromosomes blowing out from one metaphase spread, and possibly into another). We list non-clonal findings to make you aware that we did see a cell with some change, but that change has not (and maybe will not) rise to the level of something that would then make the karyotype abnormal.

Please note that we do not list non-clonal whole chromosome loss in the reports as we generally regard it as a technical artifact unless it rises to a clonal level (three or more cells).

In cases of abnormalities that are reported to be recurrently acquired in stem cells (e.g. extra chromosome 8, 12, 20, etc.), we will examine an additional twenty cells to detect low-level mosaicism.

How do I interpret the results of the pluripotency assay?

The STEMdiff™ Trilineage Differentiation Kit is used to assess the differentiation potential of the sample(s) submitted. hPSCs are differentiated to three germ layers (ectoderm, mesoderm, and endoderm) and analyzed by flow cytometry for lineage specific markers. The sample is considered pluripotent if it demonstrates the potential to differentiate to the three germ layers. For more information on assessing pluripotency, please see: STEMdiff™ Trilineage Differentiation Kit and Human Pluripotent Stem Cells. You can also learn more about assessing pluripotency by visiting the following webpage. If you have further questions, please contact your local STEMCELL representative.

How do I interpret the results of the undifferentiated status assay?

The hPSC sample will be stained for surface markers associated with the undifferentiated state (OCT4, SSEA4, SSEA3, TRA-1-60, TRA-1-81) as well as a negative control (SSEA1). Interpretation is based on dual expression of OCT4/SSEA4; there is no consensus on a target percentage positivity. Good quality hPSC cultures are typically ≥80% dual positive. Find additional information on hPSC marker expression in this resource. If you have further questions, please contact your local STEMCELL representative.

What practices are recommended to maintain high-quality hPSC cultures?

In order to maintain your cells in a high quality state, we strongly recommend consulting the following resources: Human Pluripotent Stem Cells and Assessing and Maintaining hPSC Quality. If you have any questions about these resources, please contact your local STEMCELL representative.


hPSC Banking

How will the cell bank(s) be shipped?

To ensure that cells retain quality throughout the shipping process, we only use vapor shippers for cell transport. Shippers are qualified to maintain a temperature below -150°C for a minimum of 10 days to ensure cells arrive safely, even if delayed in transit. We do not ship cells on dry ice.

The vapor shippers are reusable and must be returned. Shipping costs are calculated to include delivery of cells as well as return of the reusable shipper. Return instructions and waybill will be provided with the shipment, and can be found inside the shipper upon delivery.

For banking services, how long will it take before the cells are returned?

For bank sizes of 25 or 50 vials, reports will be accessible in 17 - 23 weeks from the time of sample receipt. For bank sizes of 100 vials, reports will be accessible in 19 - 27 weeks.


Sample Preparation and Shipping

In what form should samples be provided?

Two cryopreserved vials of each sample should be provided. The cell vials must be an appropriate size to be stored within a typical 10x10 cryobox (e.g. 1.8 - 2 mL cryovial).

How should the shipment be prepared?

What can I do prior to sample submission to best ensure that services proceed in a successful and timely manner?

Please consult this Technical Bulletin for recommendations on how to best prepare your samples. If you have additional questions, please contact your local STEMCELL representative.



Related Resources

Technical Bulletin
Outsource Your Characterization and Banking of Human Pluripotent Stem Cells
Webinar
Nature Research Round Table: Standards for Pluripotent Stem Cell Banking
Webinar
Best Practice Criteria for Pluripotent Stem Cell Lines
Brochure
Products for Human Pluripotent Stem Cells

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