iPSC Banks

Yes. uBriGene supports GMP iPSC cell bank development and manufacturing for preclinical and clinical development programs. GMP cell banking can include master cell bank establishment, characterization, quality testing, and documentation appropriate to the intended manufacturing and regulatory strategy.

Donor screening and documentation for iPSC cell banking depend on the source material, intended use, and applicable regulatory requirements. uBriGene follows applicable requirements under 21 CFR Part 1271 for donor material procurement and maintains documentation supporting donor eligibility, screening, and traceability. Specific requirements can be defined according to the cell source and development program.

uBriGene’s iPSC cell-bank characterization and release testing can include identity, stemness and pluripotency markers, cell viability, genetic stability, sterility, mycoplasma, adventitious-virus testing, and other cell-bank-specific quality attributes. Pluripotency can be assessed using flow cytometry for markers such as SSEA4, TRA-1-81, SOX2, and NANOG, together with differentiation-based assays as applicable to the cell-bank program.

uBriGene supports the development and manufacture of iPSC cell banks for research, preclinical, and clinical development programs. Depending on the program, cell banking can include master cell banks (MCBs), working cell banks (WCBs), and other qualified cell banks required for downstream iPSC manufacturing.

An iPSC master cell bank (MCB) is a qualified, well-characterized primary bank established as the controlled source for generating downstream working cell banks. A working cell bank (WCB) is derived from the MCB and is typically used to support routine manufacturing while preserving the MCB as the reference source. Establishing both can help provide consistency and traceability across an iPSC manufacturing program.

uBriGene’s RNA-LNP iPSC Reprogramming Kit is a ready-to-use lipid nanoparticle formulation for reprogramming somatic cells into induced pluripotent stem cells (iPSCs). The cocktail delivers RNAs encoding five reprogramming factors and is designed for fibroblast, PBMC, and other somatic-cell reprogramming applications.

The RNA-LNP cocktail delivers reprogramming-factor RNAs into somatic cells, triggering their conversion into induced pluripotent stem cells (iPSCs). Because the reprogramming factors are delivered as RNA, this non-integrating approach does not require DNA delivery or an integrating viral vector, reducing the risk of permanent genomic changes.

The workflow involves repeated RNA-LNP treatments followed by culture, colony formation, selection and expansion, and characterization of the resulting iPSC lines.

RNA-LNP iPSC reprogramming offers several advantages over Sendai-virus reprogramming. The RNA-LNP cocktail avoids gene integration, provides high reprogramming efficiency with low cytotoxicity, and can be delivered directly to cells without transfection reagents or viral manipulation.

It also avoids the additional passaging required for Sendai-virus clearance. Sendai-virus reprogramming may require up to 10 iPSC passages for viral clearance, whereas RNA-LNP-mediated reprogramming does not require additional passaging for viral clearance. This difference can simplify the workflow and reduce time and cost. The comparison is supported by a published study of mRNA-Lipid Nanoparticle-Mediated Reprogramming and Standard Sendai Virus Reprogramming: Generation of iPSCs and iPSC-Derived Cardiomyocytes.

The RNA-LNP iPSC reprogramming process typically takes approximately 15–18 days to reach the selection and expansion stage. iPSC-like cells may appear around Day 11, with typical colonies forming around Day 13. The exact timeline can vary depending on the starting cell type and culture conditions.

Yes. iPSCs generated using uBriGene’s RNA-LNP reprogramming cocktail are characterized for pluripotency. The resulting cells express key pluripotency markers, including SSEA4, TRA-1-81, SOX2, and NANOG, and uBriGene’s iPSC characterization program can include differentiation-based assessment of pluripotency.