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Congressman Jim Baird (IN-04) introduced the Bioindustrial Infrastructure for Open Scale-up, Commercialization, and Accelerated Launch Ecosystems (BIO-SCALE) Act. This legislation will establish three or more product-agnostic, nonprofit, pre-commercial scale-up facilities for the scaling of non-pharmaceutical biotechnologies.

“We must continue to lead the world in biotechnology, and the United States remains a premier place to scale biotechnology,” said Congressman Baird. “However, widespread use of life-changing innovations is often stalled because of roadblocks to the commercial production of biotech products. This legislation will help remove these roadblocks and create the tools necessary to bring biotechnologies to market by authorizing a network of pre-commercial facilities. I am proud to lead this legislation to help advance biotechnology to market and keep America at the forefront of innovation.”

“Breakthrough science is just the first step--biotechnology innovators must also prove their products can be scaled,” said National Security Commission on Emerging Biotechnology Commissioner Alexander Titus. “The BIO-SCALE Actwill help fill a critical gap between transformative ideas and a new biotech product coming to market, giving biotech entrepreneurs a real shot at unlocking private investment and turning promising discoveries into competitive products.”

Background:

While the U.S. has abundant feedstocks, reliable utilities, extensive transportation infrastructure, and proximity to consumers, the U.S. currently lacks sufficient biomanufacturing capacity to make here what we innovate here. A major roadblock for U.S. biotechnology is proving that products and processes will work at commercial scale.

The BIO-SCALE Act requires the U.S. Secretary of Commerce to submit a plan detailing criteria for an open competition, such as site selection, cost-sharing plans, approach to stakeholder engagement, and integration with existing infrastructure.

These facilities would have two to three years for fund expenditure, based on whether a facility has prior existing infrastructure and resources. The BIO-SCALE Act sunsets funding after 10 years from the enactment date. Facilities could continue if deemed successful by the U.S. Secretary of Commerce.

Read the bill text here.

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