Some of the images from the first weeks of the COVID-19 pandemic are indelible: doctors and nurses wearing garbage bags instead of gowns and reusing the same protective mask for days at a time; homemade plastic face shields replacing professional-grade models; live coverage of deliveries of personal protective equipment to hard-hit hospitals. The...

The National Institutes of Health, U.S. Food and Drug Administration, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. While there are approximately 7,000 rare diseases, only two heritable diseases currently have FDA...

Perhaps the biggest achievement thus far at the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has been disabusing companies that are members of the Manufacturing USA innovation institute that it is smart to be “a fast second” to market.

“Nobody actually believed when we started, except apparently us naively, that we...

In December 2016, Manufacturing USA, a newly developed unit within the Commerce Department’s National Institute for Standards and Technology (NIST), announced it had received Congressional funding for its newest and 11th institute – the National Institute for Innovation in Manufacturing Biopharmaceuticals, or NIIMBL for short. With the formal NIST...

In February 2020, NIIMBL ran a three-day workshop, which included participants from the FDA, the U.S. National Institute of Standards and Technology, plus what Erickson describes as “distinguished leaders in manufacturing and process development from 14 major manufacturers and suppliers.”

In January 2021, a team of pharmaceutical experts published...