Allele offers GMP-compliant iPSC single cell cloning services to support the establishment of well-defined, stable iPSC lines for cell therapy development. Single cell cloning is performed within Allele’s cGMP-aligned iPSC platform, ensuring consistency, traceability, and regulatory readiness from clone generation through downstream application.
Our single cell cloning workflows are designed to isolate individual iPSCs and establish clonal cell lines with clearly documented lineage and growth characteristics. Clonal expansion is conducted under controlled conditions to support stable propagation while preserving key attributes required for downstream development. These workflows are integrated with standardized documentation and operating procedures to ensure reproducibility and alignment with cGMP expectations.
Throughout the cloning process, iPSC clones are managed within a structured framework that supports identity confirmation, viability assessment, and characterization at defined stages. These measures help ensure that selected clones demonstrate consistent performance and suitability for further development, manufacturing, or banking, without introducing unnecessary variability.
As part of Allele’s broader GMP iPSC offering, single cell cloning provides a reliable foundation for programs requiring well-characterized starting materials. Our approach supports both off-the-shelf and customized iPSC strategies and integrates seamlessly with downstream manufacturing, quality control, and long-term banking workflows as programs advance.
