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Allele’s work in iPSC-based cell therapy is grounded in globally patent-protected mRNA reprogramming technology and more than a decade of continuous cGMP process development. This foundation enables the production of cGMP iPSC materials that serve as reliable starting sources for cell therapy development and manufacturing. Our offerings include off-the-shelf and custom iPSC lines, autologous iPSC generation, single-cell iPSC line establishment, iPSC expansion, cell cloning, refinement, and banking—all operated under cGMP guidelines. These capabilities extend into upstream development, where protocols and processes are refined to build robust, well-defined production workflows aligned with regulatory expectations and industry standards. By defining process parameters, establishing controls, and ensuring consistency through phased progression, Allele provides a comprehensive framework that supports both early-stage development and scalable manufacturing for iPSC-based cell therapy programs.

Some additional information about Allele Biotech’s cGMP mRNA reprogramming:

  • Efficiency translates to the fact that reprogramming can be completed in as fast as a week
  • Consistency signifies an impeccable track record over the past 12 years since the establishment of the technology at Allele Biotech.
  • Speaking of cGMP at Allele Biotech, it encompasses an end-to-end approach. This spans from donor recruitment to cGMP banking and shipping, all underpinned by a commitment to quality-by-design and validation.
  • One needs to be cautious about how ‘cGMP’ is defined by a facility. Be wary of those that merely advertise cGMP but lack a validation process or the underpinning quality management system.