Our off-the-shelf iPSC lines are generated and maintained under end-to-end cGMP-compliant conditions within Allele’s established iPSC platform. All activities are governed by standardized documentation and quality systems to ensure traceability, reproducibility, and controlled handling throughout the lifecycle of each iPSC line.
Allele offers off-the-shelf cGMP iPSC lines as reliable starting materials for cell therapy development and manufacturing. These lines are established using controlled and standardized processes to support consistent quality and performance. By providing readily available iPSC starting materials, off-the-shelf lines reduce early development timelines while maintaining alignment with regulatory expectations.
Off-the-shelf cGMP iPSC lines are designed to integrate smoothly with downstream development, manufacturing, and quality control activities. Their compatibility with cGMP manufacturing frameworks enables efficient transition into later development stages without introducing unnecessary complexity or rework.
Each off-the-shelf cGMP iPSC line is characterized to support a high safety profile, exceptional stability, and demonstrated differentiation potential. Rigorous quality control measures are applied during line establishment and maintenance to help ensure consistent behavior and suitability for downstream development workflows.
Off-the-shelf cGMP iPSC lines are part of Allele’s broader GMP iPSC platform, which also includes custom and autologous iPSC options. This integrated platform approach supports flexible development strategies and allows programs to evolve while maintaining consistency and regulatory alignment.
• Off-the-shelf cGMP iPSC lines
• End-to-end cGMP compliance
• High safety profile and stability
• Demonstrated differentiation potential
• Rigorous quality control and documentation
• Compatibility with downstream development and manufacturing
