Eager to speed development of revolutionary treatments, the Food and Drug Administration recently announced that it would expedite approval of experimental gene therapies. But the regulatory process may not be the biggest obstacle here.
Biotech companies have exciting plans to introduce treatments that may be transformative, sometimes curing genetic diseases with a single treatment. And the firms are itching to test their products.
But they are struggling to obtain a critical component of the therapy: the disabled viruses used to slip good genes into cells that lack them.
This delivery system lies at the heart of many forms of gene therapy; without the disabled viruses, there is no treatment. But manufacturing them is costly and onerous.
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The result is a logjam. Firms exploring new gene therapies may wait for years in line for bespoke viruses, said Dr. Jim Wilson, director of the gene therapy program at the University of Pennsylvania’s Perelman School of Medicine.
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Other gene therapy companies are not always able to afford the manufacturing costs or find a manufacturer. Some have taken to buying slots in virus production queues years in advance — like buying a nonrefundable airline ticket long before your vacation and hoping you can get away when the time comes.
The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage
