Establishment of a Quality-Driven Manufacturing Process to Reprogram Human Donor Material into Human Induced Pluripotent Stem Cells (iPSCs) to Support Drug Discovery

The poster Establishment of a Quality-Driven Manufacturing Process to Reprogram Human Donor Material into Human Induced Pluripotent Stem Cells (iPSCs) to Support Drug Discovery presents Axol Bioscience’s standardized and traceable approach to iPSC generation for scalable in vitro disease modeling.

Key highlights include:

• ISO 9001-Accredited Quality Management System (QMS): Ensures full traceability, documentation, and standardization across all axoLines™ iPSC products.
• Ethical Consent & Licensing: Donor samples are collected under UK ethics-approved protocols, enabling genetic analysis and commercial use.
• Standardized Reprogramming: Sendai virus and episomal vector methods used to generate stable clones from skin, blood, or fibroblast samples.
• Quality Control Testing:
  • Sterility (broth, qPCR, microbiological growth)
  • Mycoplasma and viral screening
  • Viability and growth profiling
  • Genetic identity (STR analysis, mutation confirmation)
  • Vector clearance (qPCR)
  • Karyotyping (G-banding, aCGH)
  • Pluripotency (OCT3/4, NANOG, TRA-1-60, SSEA-3/4)
  • Differentiation potential (embryoid body scorecard)
• Certificate of Analysis (CoA): Generated for each line, summarizing QC results and confirming release status.
• Data Management: Q-Pulse system used for SOPs, forms, reports, and version control, ensuring ongoing compliance and updates.
• Scalability: Over 50 iPSC lines manufactured from patient and healthy donors, supporting comparative studies and reproducible assay development.

This quality-driven framework enables the creation of robust, human-relevant iPSC models for drug discovery, reducing variability and enhancing translational potential.

Featured Axol Products:

• axoCells™ Motor Neuron Progenitors – ax0074, ax0078
• axoCells™ Motor Neuron Accelerator – ax0072, ax0179
• axoCells™ Cardiomyocyte Maintenance Medium – ax2530
• axoCells™ Human Fibronectin – ax0050