A strategy to mitigate US pharmaceutical supply chain risk
seeks to identify and commercialize new synthesis pathways for
critical drug substances based on domestically sourced
materials.
MINNEAPOLIS, June 18, 2024 /PRNewswire/ -- Today, the US
depends on imports from China and
other overseas sources for a majority of the active pharmaceutical
ingredients (APIs) used to make drug products critical to US
patients. The National Institute for Pharmaceutical Technology and
Education (NIPTE) today announced a strategy for mitigating this
risk to the US pharmaceutical supply chain and the US population
who depend on access to these life-saving medicines.
"If a major disruption of international commerce prevented the
US from importing APIs and finished pharmaceutical products, the
impact could be catastrophic," says Vadim
J. Gurvich, Executive Director of NIPTE and Research
Associate Professor at the University of
Minnesota. "We currently lack much of the industrial
capacity needed to replace API imports. We need to find consensus
and begin to implement a plan."
A strategy, described in a publication on NIPTE's website
nipte.org, identifies several needs and structures a plan of
activities to identify the 50 most critical medicines as well as
new synthetic pathways for both APIs and excipients using chemical
building blocks that are manufactured in the US or closely allied
countries. The work would build on existing critical medicine lists
and would use AI tools to optimize manufacturing routes for the
portfolio of drugs.
"AI-assisted retrosynthetic analysis and reaction databases can
be used to create potential routes to each regulatory starting
material (RSM). Other tools will be expanded to predict impurities
and identify separation procedures," explains Gurvich. "In
developing updated, advanced manufacturing processes, we can also
build in efficiency and environmental and economic
sustainability."
Such efficiencies could translate to lower-cost processes for
generic drugs, which could help alleviate drug shortages.
"We are issuing a call to action to refine the identified
priorities and begin to work towards implementation," says Gurvich.
"The time to act is now."
About NIPTE
The National Institute for Pharmaceutical Technology and
Education (NIPTE) is a non-profit academic organization of 17 US
universities that collaborate with industry, academia, and
government to improve the way medicines are designed, developed,
and manufactured to meet the needs of patients.
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SOURCE National Institute for Pharmaceutical Technology and
Education (NIPTE)