That gap may soon narrow, though: nearly 70% of current ATMP trials are in phase 2 or 3 of clinical trials. How close are we to widely accessible, affordable ATMPs for patients?Īs of early 2021, there are twenty approved cell and gene therapies available in the U.S., a small fraction of the trials currently moving through the clinical pipeline. The solution is flexibility: as more ATMP products move towards regulatory approval and commercial scale-out, manufacturers are turning to a new kind of production facility, one that’s flexible and future-ready, capable of adapting quickly as the industry evolves and new technologies emerge. That’s a far cry from traditional biopharma facilities, where you’ll find closed and automated process technologies designed to reliably and repeatedly manufacture high-volume batches of identical products. Target patient populations are very small-sometimes as small as one, in the case of autologous therapies that rely on a patient’s own cellular material as the therapeutic vehicle. That’s because ATMP manufacturing processes are, for now, largely open and operator-driven. The greatest of those challenges is one of scale: few ATMP manufacturers have successfully transitioned from early lab-based research to a hardened and sustainable commercial process. ATMP innovators are on the cusp of forever changing that prognosis.īefore they do, these innovators must overcome all-new manufacturing challenges. This investment is funding more than 1,200 clinical trials of personalized cell and gene therapies worldwide as of early 2021, many of them focused on the life-threatening cancers, cardiovascular diseases, and genetic disorders that-until now-could only be managed, not eliminated. In 2020 alone, the global ATMP industry raised $19.9B in annual financing, a 200% increase over 2019. That’s the big promise of ATMPs, and it’s attracting big numbers.
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