Allogeneic iPSC-derived therapies hold immense promise, offering scalable, off-the-shelf solutions for a wide spectrum of diseases. However, the journey from donor cells to a gene edited, clinically compliant GMP Master Cell Bank (MCB) is fraught with challenges and is particularly vulnerable to risks stemming from misaligned early development.
A major bottleneck seen in the majority of iPSC therapeutic programs arises when development teams continue to rely on R&D grade cell lines to confirm proof-of-concept, conduct preclinical animal studies, and to start process & analytical development. [Read more…]
