Challenges in Moving Pharmaceutical Manufacturing to the US

Moving pharmaceutical manufacturing to the US can be a complex and time-consuming process, potentially taking years to complete1.

Major challenges include:

Limited existing manufacturing facilities suitable for modern products like biologics in the US1
Long lead times (up to 4 years) for designing, building, and qualifying new manufacturing facilities1
Significant costs associated with building new facilities (e.g. $1-2 billion for large-scale biologics facilities)1
Extended timelines (up to 18 months) for ordering and receiving key equipment like filling lines1
Time-consuming product transfer processes, taking up to 2 years per product1

Bavarian Nordic, a Danish biotechnology company, has manufacturing facilities in Denmark and Switzerland, with additional facilities in Germany and the US5.

The company has been expanding its manufacturing capabilities through partnerships and acquisitions:

Acquired travel vaccines from GSK in 2019 and Emergent BioSolutions in 20235
Entered a contract manufacturing agreement with Biological E Limited in 2025 to expand vaccine production capacity for low- and middle-income countries6 7

Bavarian Nordic has been focusing on expanding its global reach and manufacturing capabilities for vaccines, particularly for diseases like smallpox, mpox, and chikungunya6 7 9.