Pharmaceutical Manufacturing in America

BARDA'S COMMITMENT TO EXPANDING PHARMACEUTICAL MANUFACTURING IN THE UNITED STATES

EXPANDING PHARMACEUTICAL MANUFACTURING IN THE UNITED STATES Support Servicesy MCM Portfolio Clinical Trials
BARDA launched new strategic partnerships starting in May 2020 to expand Pharmaceutical Manufacturing in America (PMIA) and has continued making investments throughout the pandemic.
manufacturing

The Mission

The PMIA initiative is strengthening pharmaceutical manufacturing capacity for medical countermeasures in the U.S. by investing in critical supplies and capabilities ranging from raw materials to fill/finish services. PMIA is increasing the ability within the U.S. to manufacture the consumables used in vaccine production (e.g., tubing, assemblies, filters, buffers) and the raw materials and other ingredients required to manufacture life-saving drugs and vaccines (e.g., APIs, lipids, nucleotide triphosphates (NTPs), reagents).

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BARDA is also working to strengthen the domestic capacity to produce generic drugs as well as the ancillary supplies (e.g., needles, vials, and syringes) needed to deliver vaccines and other therapies. To fortify health security, BARDA will continue to invest in domestic manufacturing and infrastructure improvements to ensure rapid MCM manufacturing, scale-up, and domestic fill/finish capacity to support future public health emergencies.

The Challenge

For public health and economic security, the U.S. must maintain access to key components of the pharmaceutical industrial base and supply chain, which are currently manufactured outside the U.S. A majority of APIs and their chemical compounds needed for critical medicines are also manufactured abroad. BARDA’s PMIA partnerships aim to increase the domestic industrial base to allow for the additional raw material and consumables production necessary to support the manufacturing of therapeutics and vaccines during a public health emergency or pandemic.

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Without access to these critical supplies, raw materials and services, United States Governments response capability is limited and reliant on foreign sources. By leveraging BARDA’s experience in building novel public private partnerships, BARDA is improving access to U.S. supplies and services for this pandemic, and ensuring we are better positioned for the next public health emergency.

The Opportunities

With funding provided by Congress under “Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020” and “Coronavirus Aid, Relief, and Economic Security Act’’ (CARES Act’) and the “America Rescue Plan - Domestic Manufacturing Capacity & Supply Chain” (Section 2303) signed in March 2021, BARDA is leading the expansion of U.S.- based pharmaceutical manufacturing capacity.

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BARDA has made previous investments to expand U.S.- based biological manufacturing capacity by helping private sector partners build or retrofit manufacturing lines, establishing three Centers for Innovation and Advanced Manufacturing (CIADMs), and a Fill Finish Manufacturing Network (FFMN). COVID-19 funding and authorization enabled BARDA to build on that experience by expanding into new public-private partnerships that further increase U.S.- based pharmaceutical manufacturing capabilities and strengthen the MCM supply chain. These new partnerships highlighted below provide a unique opportunity to develop an end-to-end domestic manufacturing capability to significantly improve our Nation’s domestic pharmaceutical supply chain and preparedness for future pandemics.

The Impact

The Pharmaceutical Manufacturing in America initiative will enhance the Nation’s ability to respond to public health emergencies through expanded and accelerated vaccine manufacturing capacity, enable sustained access to life-saving and life-enhancing medicines and therapeutics, and add to supply chain resiliency.

BARDA’s COVID-19
Domestic MCM Manufacturing CapacityX Strengthening
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MCM Manufacturing Capacity Strengthening

BARDA is making critical investments to accelerate the expansion of domestic manufacturing capacity for ancillary supplies (e.g., needles, syringes, vials) as part of our commitment to foster and expand domestic pharmaceutical manufacturing.

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Next Generation Manufacturing Investments

BARDA is making critical next-generation and continuous manufacturing investments to drive innovation in manufacturing.

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MCM Industrial Base Expansion

BARDA is investing in the domestic industrial base to sustain the manufacturing capacity for raw materials, critical ingredients, consumables, and facilities required to produce COVID-19 (and future) vaccines and therapeutics.