Modernizing Your Way to Success In Cell And Gene Therapy Manufacturing

By James Jardine, GxP Lifeline Editor, MasterControl

The landscape of cell and gene therapy (CGT) has undergone a remarkable transformation in just a few short years. When Kymriah became the first CGT product to receive regulatory approval five years ago, the field was still considered a niche corner of the biopharmaceutical industry. Fast forward to today, and CGT has emerged as one of the most dynamic and rapidly expanding sectors in life sciences. What was once viewed with cautious optimism is now a magnet for innovation and investment, boasting a pipeline that is both deep and diverse. Over 1,300 companies are now actively engaged in CGT manufacturing, and 11 gene therapy medicinal products have secured valid marketing authorizations—clear indicators of the sector’s accelerating momentum. The recent approval of bluebird bio’s Skysona, a groundbreaking gene therapy priced at $3 million per patient, underscores the scale and ambition of what’s now possible in this space.

As CGT continues to redefine the boundaries of modern medicine, now is the time for stakeholders across the healthcare ecosystem—researchers, investors, clinicians, and policymakers—to engage, collaborate, and innovate.