Catalent’s iPSC GMP cell banks utilize specialized reprogramming technology to transform commercial-use donor consented, clinically approved, cord blood collections into HLA-homozygous lines that are immune compatible with a wide population. These GMP cell banks achieve current FDA and EMA compliant standards and extensive characterization of both the iPSC lines and the corresponding donor tissue.
Our cell and gene therapy custom development and manufacturing expertise focuses on an integrated vision from plasmid DNA manufacturing, process assessment and development, manufacturing scaleup to analytical method development. Our dedicated iPSC expert team is comprised of the right blend of iPSC scientists and manufacturing experts working together to develop the next-generation scalable platforms to manufacture iPSC-based therapies
Our complete toolkit offers the building blocks to industrialize iPSC-based cell therapies:
- GMP lines and non-GMP equivalents, including human leukocyte antigen (HLA)-matched cell banks
- iPSC reprogramming and differentiation services
- Characterization, manipulation & release testingof iPSC banks
- Cryopreservation and bank storage
- Process development, manufacturing and analytical method development for iPSC therapies
With global facilities and clinical- through commercial-scale production capabilities, our team is ready to deliver a full value chain offering for your iPSC program with the right tools, services and expertise to accelerate your path to clinic.