Induced pluripotent stem cells (iPSCs), reprogrammed with integration-free mRNA from FDA-compliant donor cells sourced in the USA, have been fully characterized and released.
iPSC banks were generated in a GMP-compliant cleanroom in accordance with regulatory requirements. Reprogramming was performed using our efficient RNA-LNP kit with donor cells sourced from the USA.
Donor sourced from the USA, fully FDA compliant
Generated using mRNA reprogramming, no genomic footprint
Fully characterized and rigorously tested
Multiple iPSC banks available
The various Rep/Cap plasmids and helper plasmids have been tested for high quality and high yield in GMP AAV production.
We have assisted our clients in obtaining IND clearance with AAV produced using these AAV helper plasmids.
| Product Name | Catalog Number | Description | Product Grade | Product Size | Price (Research Grade) |
|---|---|---|---|---|---|
| iPSC-Cells-Banks | IPSC-BANK-SC-R | Single cell-derived iPSC line: Generated using uBriGene’s mRNA-LNP reprogramming mix from fibroblasts. | Research | 1mL/vial | $1,860 |
| IPSC-BANK-SC-G | GMP | 1mL/vial | Please Inquire | ||
| IPSC-BANK-CL-PR | iPSC clonal cell banks: Generated using uBriGene’s mRNA-LNP reprogramming mix from PBMCs. | Research | 1mL/vial | $1,550 | |
| IPSC-BANK-CL-R | iPSC clonal cell banks: Generated using uBriGene’s mRNA-LNP reprogramming mix from fibroblasts. | Research | 1mL/vial | $1,550 | |
| iPSC-Cells-Culture-Media | iPSC-Media | Media for iPSC cell culturing | ☑Research ☑GMP | 500mL/bottle | Please Inquire |
Note: Research use only. Licensing is required for commercial use. View the product's LULL.
iPSC Cell Banks
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Extensive iPSC generation and banking experience with access to essential raw materials, including iPSC reprogramming mRNA-LNP mix and CRISPR gene editing tools.
Extensive plasmid production experience
100+ GMP plasmid projects annually
| Donor | Cell Source | Disease | Reprogramming Method | Format | Storage Temperature | Vial Size |
|---|---|---|---|---|---|---|
| Asian, female, 38 | Skin Fibroblasts | Healthy | RNA-LNP | Cryo-preserved | -160oC | 1mL |
Healthy fibroblasts from a U.S. donor were reprogrammed using uBriGene’s RNA-LNP kit. iPSC clones are picked ~2 weeks later, cryopreserved as seed banks at P2–P5, and expanded into MCBs via single-cell cloning for clinical use.
RUO iPSC lines are developed from seed banks and support stem cell research, regenerative medicine, and disease modeling. Gene editing services and products are also available — contact us to learn more.
Fig. 1. RUO iPSC lines and GMP iPSC banks generation diagram using uBriGene’s reprogramming mRNA-LNP cocktail mix.
The iPSC colonies were identified with AP staining on day 18. The results showed that iPSC colonies were positive for AP staining, with reprogramming efficiency reaching as high as 10%.
Fig. 2. iPSC identification using Alkaline phosphatase staining after the iPSC reprogramming process with mRNA-LNP cocktail.
Flow cytometry analysis showed that iPSCs cell banks generated by iPSC Reprogramming mRNA-LNP Cocktail express undifferentiated cell markers (SSEA4, TRA-1-81, Sox2, and Nanog).
Fig. 3. Detection of pluripotency identification markers for uBriGene’s iPSC cell bank, including SSEA4, TRA-1-81, Sox2, and Nanog, using flow cytometry.
iPSC cell banks generated using uBriGene’s reprogramming mRNA-LNP cocktail are tested for pluripotency. Embryoid bodies are differentiated from the iPSCs and specific cell lineage cell markers are detected via immunofluorescence staining.
Fig. 4. iPSC cells were differentiated into embryoid bodies to demonstrate the pluripotency of the iPSCs generated using our iPSC reprogramming mRNA-LNP cocktail. Immunostaining was performed for Nestin, MAP2, AFP, and SMA.
Our iPSC master cell banks were rigorously characterized for stemness, pluripotency, genetic stability, safety, and the absence of adventitious viruses.
| Test Item | Method | |
|---|---|---|
| Appearance | Visual observation | |
| Identity | Cell morphology | Microscopic observation |
| Karyotype analysis* | G-banding | |
| STR* | STR | |
| Stemness Markers | SOX-2 | Flow Cytometry |
| Nanog | ||
| Oct4 | ||
| SSEA4 | ||
| TRA1-60-R | ||
| TRA1-81 | ||
| Cell Viability | Cell viability | Trypan Blue/AOPI |
| In Vitro Pluripotency | Trilineage differentiation | Immunofluorescence staining |
| In Vivo Differentiation | Teratoma formation* | Animal inoculation method |
| Safety | Sterility | Culture Method |
| Mycoplasma Testing | ||
| Mycobacterium Testing* | ||
| Adventitious Viruses | Cell morphology observation and hemadsorption test* | Pharmacopoeia method |
| TEM* | ||
| In vitro inoculation and culture method with different cell types* | ||
| Retrovirus examination* | ||
| Inoculation method in animals and chicken embryos* | ||
| Bovine-derived virus detection* | ||
| Human-derived virus detection | ||
| Impurity | Residual antibiotics | ELISA |
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uBriGene’s iPSC Reprogramming mRNA-LNP cocktail is a ready-to-use lipid nanoparticle formulation containing mRNAs for five reprogramming factors. It is designed to efficiently reprogram somatic cells, like human fibroblasts, into iPSCs without altering the cell genome.
The mRNA-LNP cocktail delivers reprogramming mRNAs into somatic cells, triggering them to convert into induced pluripotent stem cells (iPSCs). This non-integrating method reduces the risk of permanent changes to the genome.
mRNA-LNP reprogramming cocktail avoids the risk of gene integration, offers high efficiency, and has low cytotoxicity. It also simplifies the process since no transfection reagents or viral manipulation are required.
The reprogramming process usually takes about 15–18 days. iPSC colonies typically emerge around day 13, and are large enough for selection and expansion by day 15.
Yes, iPSCs generated using uBriGene’s mRNA-LNP cocktail are pluripotent. They express key pluripotency markers such as SSEA4, TRA-1-81, Sox2, and Nanog.
iPSC cell banks are tested for the expression of undifferentiated cell markers (SSEA4, TRA-1-81, Sox2, and Nanog) via flow cytometry to ensure high-quality iPSC generation.
uBriGene’s iPSC seed banks and maser cell banks were manufactured in compliance with GMP standards, making them suitable for preclinical and clinical applications.
We offer off-the-shelf GMP-grade Cas proteins and mRNAs. Additionally, uBriGene has developed an innovative in vitro transcription technology for sgRNA, providing higher scalability and cost-effectiveness for large-scale sgRNA production.
Yes, we follow the guidelines outlined in 21 CFR 1271 and maintain comprehensive governing documentation, including Trial Master Files for donor materials.
Extensive expertise with a track record of successfully releasing over 60 GMP batches of AAV.
iPSC Cell Banks for clinical use
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
