The number of studies focusing on induced pluripotent stem cell (iPSC)-based therapies has significantly increased in recent years, leading to a variety of pre-clinical and clinical studies in the treatment of conditions such as retinopathies, cardiovascular diseases, and neurodegenerative disorders. It is anticipated that Japan will soon grant market authorization for the first iPSC-based cell therapy designed to treat heart failure. As research on iPSCs progresses and knowledge in this field grows, various approaches are being employed to address critical chemistry, manufacturing, and controls (CMC) challenges, which include improving reprogramming efficiency, characterizing iPSCs and their derived cell products, and ensuring quality consistency, etc. Porton Advanced offers an integrated CMC service for iPSC-based cell therapies, supported by our extensive experience in stem cell and immune cell therapies.
We offer integrated CMC services ranging from reprogramming factor delivery vectors, reprogramming, to cell differentiation and large-scale manufacturing:
- Episomal vectors, lentiviral vectors, and mRNA production for reprogramming
- Cell reprogramming and iPSC colony selection
- Gene modification/editing
- GMP cell banking and cell storage
- iPSC differentiation
- iPSC-derived cell product GMP manufacturing
- Process development and optimization
- Analytical method development and optimization, analytical qualification, and validation
- Testing Services for drug substance (DS) and drug Product (DP)
- CMC information writing and regulatory submission
