Centers of Excellence

Background

Advanced and continuous manufacturing has become a growing priority in the FDA’s agenda to improve quality, safety, and access since the early 2000’s. Many companies have succeeded in implementing these technologies and getting products approved. The need to build a strong supply chain has also become a matter of national urgency. In December 2022, President Biden signed into law a congressional bill requiring the
FDA to designate up to five national Centers of Excellence in Advanced and Continuous Manufacturing (HR 4369). The new law also authorized $100M in funding for the FY23-27 period.

Our Strengths

As a coalition of 18 universities, The National Institute for Pharmaceutical Technology & Education:

• Comprise most of the existing academic capabilities in the U.S. for advanced and
  continuous manufacturing.

•  Include a wide range of areas of expertise: small and big molecule, solid dose,
  injectables…

• Feature a long track record of fruitful collaborations with the industry, the FDA,
  and other federal and state organizations.

• Provide an expansive geographical footprint.