FAQ - Custom iPSC Services

Questions About Service Packages

1. What does REPROCELL’s iPSC research reprogramming service include?

Every service project is milestone-based and customizable to meet your needs. For our research iPSC services, REPROCELL handles everything from donor tissue collection through to differentiation into specific cell types.

Services:

Donor tissue collection
Sample quarantine
Primary cell line derivation
RNA-based iPSCs reprogramming
Expansion
Characterization
Cryopreservation
Differentiation into specific cell types
Genome-editing
Cell banking

Quality Control (QC):

Mycoplasma testing
Infectious disease check
STR analysis
Live-staining for pluripotency markers (immunocytochemistry)
Functional pluripotency assay by tri-lineage differentiation
Enhanced assays (available via strategic partners):
- Karyotyping
- Flow cytometry
- Teratoma formation
- CGH/SNP arrays

2. What is the StemRNA 3^rd Gen Reprogramming Technology?

The StemRNA 3^rd Gen Reprogramming Technology is a non-integrating system that uses only RNA to reprogram somatic cells into iPSCs. The StemRNA 3^rd Gen Reprogramming Kit contains six reprogramming RNAs (OCT4, SOX2, KLF4, c-MYC, NANOG, LIN28), three immune ablating RNAs, and a proprietary miRNA cocktail to generate footprint-free iPSCs. No screening for residual RNA vector required because by using our technology, all RNA is cleared and degraded within 18-24 h after delivery into the somatic cell.

3. What primary cell types can be reprogrammed with the StemRNA 3^rd Gen Reprogramming Technology?

Validated cell types include adult and neonatal fibroblasts, blood-derived endothelial progenitors, urine-derived progenitor cells, dental pulp, nasal epithelial cells. For other human or non-human cell types not yet validated, we offer milestone-based development projects. REPROCELL can also procure starting cell source tissues via its custom collection network.

4. What are the timelines and costs for your iPSC reprogramming service?

The StemRNA 3^rd Gen iPSC technology is one of the fastest and most efficient iPSC reprogramming technologies available. With StemRNA 3^rd Gen reprogramming, iPSC clones reach expansion-ready status by day 10-15, and full banking is completed in an additional 2-3 weeks. We also offer the option for a bulk reprogramming package, where one iPSC line is generated by pooling clones and is available for even faster use.

The exact timeline and costs will vary depending on the QC and target cell type, but typically runs 2-4 months from tissue collection. Contact us to discuss timelines and costs for your particular project.

5. Can you source donor or patient tissue for us as well?

Yes, REPROCELL’s Bioserve brand is well known for custom prospective collection services through our global partner network. Through our BioServe Tissue network, we can source the starting tissues you need for your project. The Biopta brand provides 24/7 operation for fresh human-tissue collection and receipt outside regular hours.

6. Can you reprogram a patient sample from your existing Bioserve patient biorepository?

Most standard Bioserve biorepository samples (serum, DNA, RNA, FFPE) are not suitable for iPSC generation.

7. Will you keep a stock of the patient material or patient-derived iPSCs yourself?

Upon completion of the reprogramming project, all patient material provided by you for the service, as well as the resulting patient-derived iPSCs, may be returned to you. You may choose to: (i) arrange return shipment at your own expense; (ii) request continued storage and pay the applicable archiving fee; or (iii) request destruction of the material. If the tissue was sourced by REPROCELL, those samples remain the property of REPROCELL.

8. Which location are your iPSC services provided from?

US (Maryland)
Japan (Yokohama)

9. What are the differences between the US and Japan iPSC service labs?

Both sites operate under the same or highly aligned Standard Operating Procedures (SOPs). While specific QC outsourcing partners may differ, the service packages remain consistent, allowing projects to be executed at the location best suited for your sample logistics and program requirements.

10. Can you provide iPSC differentiation services as well? Which cell types?

Yes. REPROCELL was the first company to commercialize differentiated iPSC-derived cells. Across all our service sites, we routinely differentiate iPSCs into cardiomyocytes, hepatocytes, multiple immune cell types, and neurons. We use established in-house protocols but can also follow customer-provided methods when required. Additional lineages—such as muscle cells, RPE, dopaminergic neurons, and sensory neurons—can also be accommodated following project consultation.

Questions About Competitors / Pricing

1. Why is your method (3^rd Gen RNA) better and different compared to other reprogramming technologies on the market?

REPROCELL’s StemRNA™ 3rd Generation RNA reprogramming technology is proprietary to our company and represents the fastest and cleanest RNA-based reprogramming method available (see Specification Sheet).

2. It is the only RNA-based platform capable of reprogramming adult and neonatal fibroblasts, as well as blood- and urine-derived cells, into iPSCs—an important advantage when a skin punch biopsy is not feasible.

In contrast, many competitors rely on Sendai virus or episomal DNA approaches, which often result in residual vector retention and require prolonged culture or additional screening to confirm clearance. StemRNA™ 3rd Gen avoids these issues entirely, offering a footprint-free, rapid, and highly efficient reprogramming workflow.

3. Can I get a discount on multiple iPSC lines?

Each iPSC generation contract is scoped and priced independently. Discounts are not guaranteed, but they may be possible if:

Multiple donor samples are submitted at the same time, allowing parallel processing, or
You bundle additional services such as differentiation.

For specific pricing options, contact our experts.

Questions About License Model / Freedom to Operate

1. Can I use the iPSCs for a cell therapy program we are working on?

REPROCELL’s StemRNA 3rd Generation reprogramming service is for research use only. iPSCs generated with this technology are not consented or qualified for clinical cell therapy applications.For clinical cell-based programs, REPROCELL provides reprogramming services using its clinical-grade StemRNA 5.0 technology—available either as a custom service or as pre-established, ready-to-use clinical iPSC lines:

2. Can you provide GMP grade reprogramming services?

We can generate clinical-grade iPSCs that are manufactured using our StemRNA 5.0 proprietary footprint-free RNA reprogramming technology and clinical-grade media reagents. To find out more, please visit our Clinical-grade iPSCs & GMP MCBs FAQ page.

3. What is my Freedom to Operate, and is there a royalty model?

There are no upfront fees, annual maintenance fees or royalties if the customer does not commercialize the product, such as for internal R&D projects. The freedom to operate will be detailed in the User Agreement that will be sent to you together with the service contract. Commercial sales of products or services using differentiated iPSCs or derivatives requires a separate Commercial Agreement. Distribution (passing and sale) of undifferentiated iPSCs is by default not allowed without REPROCELL’s explicit written permission.

Please contact us to discuss your project and determine the correct license.

4. We would like to use these iPSCs for a research collaboration/consortium where we will be reimbursed on cost recovery basis. For participation, we would need to pass the undifferentiated iPSCs to another partner for genome-editing/ differentiation/ automated scale-up, etc. Is this possible?

Passing undifferentiated iPSCs to third parties amongst academic research groups and partners is allowed. Please inquire for specific case details.

5. We are partnering with another commercial company who will be genome-editing REPROCELL iPSC lines for us. Can I send them the undifferentiated iPSCs?

Passing undifferentiated iPSCs to third parties for genome editing is allowed, provided the cells and any derivatives are not used for commercial sale or commercial gain.

6. Can I differentiate the iPSCs into neurons, hepatocytes, cardiomyocytes, or other lineages for providing commercial (screening) services to other companies?

Yes, but a separate commercial license is required for any use involving commercialization of differentiated iPSC-derived cells. Please contact REPROCELL for more information and licensing details.

7. Can I sell differentiated iPSC-derived cells to other companies or universities?

Yes, but a separate commercial license is required for any use involving commercialization of differentiated iPSC-derived cells. If you intend to sell or otherwise commercialize these materials, you must contact REPROCELL to obtain a separate commercial license.

8. Can I send undifferentiated iPSCs to a partner company or university lab for differentiation using their own protocols?

Passing undifferentiated iPSCs to third parties is permitted for research purposes only, provided that the cells or their derivatives will not be used for commercial sale or commercial gain. REPROCELL retains its own in-house expertise for differentiation. Please contact us to discuss your project and confirm compliance with the appropriate terms.

Frequently Asked Questions About Our Custom iPSC Services