mRNA Reprogramming

Allele’s iPSC-based cell therapy platform is built on globally patent-protected mRNA reprogramming technology and over a decade of continuous cGMP process development. This foundation enables the production of cGMP-compliant iPSC materials for cell therapy development and manufacturing, including off-the-shelf and custom iPSC lines, autologous iPSC generation, single-cell cloning, expansion, refinement, and banking. These capabilities support both early-stage development and scalable manufacturing under a phased, regulatory-aligned framework.

mRNA Differentiation

Using the same mRNA technology, Allele has established a broad portfolio of iPSC differentiation protocols supporting diverse cell therapy applications. These include functionally mature cell types and lineage-committed progenitors, with multiple programs fully developed and cGMP manufacturing-ready. Additional protocols are compatible with cGMP principles and can be adapted through customized development to meet specific project needs.

However, if you encounter challenges related to the efficiency or consistency of your differentiation protocol, or if you are contemplating the launch of an iPSC-based cell therapy program, we encourage you to get in touch with us via email at info@allelebiotech.com. We may have a ready-to-implement solution that fully suits your needs.

mRNA Genome Editing

Allele has developed a validated iPSC genome editing platform integrating Mad7 CRISPR technology with mRNA-based engineering. The platform supports knock-out, knock-in, and safe-harbor insertion workflows designed for cGMP-oriented development. Qualified analytical methods are applied to support downstream development through genetic, epigenetic, identity, and biomarker testing.

For project-specific discussions or customization needs, please contact us at info@allelebiotech.com.

cGMP iPSC Single Cell Cloning

Single-cell iPSC cloning is integrated within Allele’s cGMP-compliant iPSC platform, supporting the generation of stable and well-characterized iPSC lines. These workflows incorporate expansion, banking, and comprehensive quality control to ensure safety, stability, and consistency for downstream cell therapy development.

Quality and Compliance Systems

Allele operates a comprehensive cGMP quality system supporting both development and manufacturing of cell therapy products. Our QC capabilities include cGMP-validated assays for in-process and release testing, managed within a structured Quality Management System covering documentation, change control, qualification, and continuous compliance.