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.
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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.

Multiple Requests for Information (RFI):

SELECT A RFI FOR DETAILS

BARDA Needs Your Assistance!

Q:
Could your organization help strengthen the industrial supply chain for medical countermeasure (MCM) production, manufacturing, and implementation?
A:
If you answered YES to the above question, please consider submitting a formal response to our Request for Information (RFI)

1. Biopharmaceutical Manufacturing Partnership (BioMaP) Consortium

RFI Main Image

Type: Sources Sought

Product Service Code: 6505 Drugs and Biologics

Place of Performance: HHS BARDA

To: Prospective Partners & Interested Parties

The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from current and potential biopharmaceutical industry partners. Information collected from this RFI will serve as continued market research for the development of a possible program where BARDA would partner with industry to achieve the pandemic preparedness goals set forth by the U.S. Government (USG).

Background: The Department of Health and Human Services (DHHS) is engaging with other Federal agencies and the White House in a whole-of-Government review, update, and transformation of U.S. bio-preparedness capabilities, as outlined in the White House’s September 2021 report, American Pandemic Preparedness:  Transforming our Capabilities.1 This effort will fundamentally transform the Nation’s biodefense and pandemic readiness and address challenges experienced during the ongoing COVID-19 pandemic. Work is being organized across five pillars: (I) Transforming our Medical Defenses, (II) Ensuring Situational Awareness, (III) Strengthening Public Health Systems, (IV) Building Core Capabilities, and (V) Managing the Mission.

The subject of this Sources Sought are Goal I: Transforming our Medical Defenses and Goal IV: Building Core Capabilities, as they pertain to BARDA’s ongoing effort to expand the industrial supply chain for medical countermeasure (MCM) production, manufacturing, and implementation.2

1White House Office of Science and Technology Policy (OSTP), American Pandemic Preparedness Transforming our Capabilities, September 2021, https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf.

2Gary Disbrow and Ian Watson, “Expanding the domestic public health supply chain is a matter of national security,: STAT, 26 Aug 2021, https://www.statnews.com/2021/08/26/expanding-domestic-public-health-supply-chain-matter-of-national-security/.

To transform and build core capabilities for biodefense, BARDA is contemplating consortia comprised of industry partners across the drug and vaccine manufacturing supply chain, including the manufacturers of required raw materials and consumables as well as suppliers of fill-finish services. The consortia will establish the physical infrastructure, manufacturing platforms, and supply chain capable of producing enough vaccines for the entire United States population within 130 days and the global population within 200 days after its recognition as a potential emerging pandemic threat and expand the ability to domestically produce the therapeutics and vital supplies to halt future pandemics.

BARDA is interested in identifying industry and private-sector partners who may be interested in participating in such consortia, supported by BARDA, that will prepare for and respond to emerging and ongoing pandemic threats focused on developing, establishing, and manufacturing capabilities to handle a broad array of threats. BARDA is interested in establishing and sustaining:

  • Facilities and organizations with experience supplying or manufacturing any of the following:
    • licensed vaccines and antibodies
    • single-use consumables such as sterile packaging, tubing, connectors, assemblies, needles
    • fill-finish services and supplies (e.g., syringes, vials)
    • suppliers of raw materials such as the solvents, reagents, and other materials
    • small-molecule and active pharmaceutical ingredient (APIs) manufacturers
  • Proven vaccine manufacturing platform technologies
  • Trained biomanufacturing workforce
  • Robust supply chain to support large-scale manufacturing
  • contracting/agreement mechanisms

Interested firms are requested to submit company contact information and responses to the following questions relating to the establishment of, and participation in, potential consortia:

  • Brief description (10 pages or less) of company experience and existing infrastructure related to manufacture or supply of any of the aforementioned resources or services; plus additional pages comprising:
  • Discussion/perspective on potential barriers (financial, technological, legal, etc.) to, and/or concerns over, participating in consortia of industry participants to meet the pandemic preparedness and response requirements;
  • Perspective on granting the USG access/rights to USG-funded infrastructure and technologies on a preferential basis (“priority access”) in the event of a declared public health emergency (PHE);
  • Perspective on sustainment of pandemic response capacities and capabilities during non-pandemic or declared PHE’s.

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY. NO CONSORTIUM OR SOLICITATION CURRENTLY EXISTS. BARDA will use this information to guide decisions and plans regarding establishing domestic biopharmaceutical consortia and to establish a contact list of potential industry participants for future outreach efforts.

Please note that contractors performing advisory and assistance services that support BARDA will have access to any submission under this RFI. Please do not include proprietary information in response to this RFI.

HHS BARDA POC: Peter Wallace, peter.wallace@hhs.gov, 508.498.6676

Closing Date: February 28, 2022

pdf icon Download Full BioMap Consortium RFI

2. Domestic Vaccine Manufacturing Capabilities Utilizing mRNA Technology

RFI Main Image

Type: Sources Sought

Product Service Code: 6505 Drugs and Biologics

Place of Performance: HHS/ASPR/BARDA

To: Prospective Partners & Interested Parties

The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from current and potential biopharmaceutical industry partners.

Information collected from this RFI will serve as continued market research for the development of a possible program where BARDA would partner with industry to achieve the pandemic preparedness goals set forth by the U.S. Government (USG).

SOURCES SOUGHT TITLE: Bolstering U.S.-based Vaccine Manufacturing Capabilities that Utilize messenger Ribonucleic Acid [mRNA] Technology

BACKGROUND: The USG has delivered over 496 million doses of mRNA vaccines for domestic preparedness. Globally, the USG is committed to donating over 1.2 billion vaccines doses. To meet short- and long-term needs, both domestically and globally, the USG seeks to increase mRNA vaccine U.S.-based production capacity for domestic and global use by at least 1 billion doses annually not later than the second half of 2022 to address the current COVID-19 pandemic and prepare for future pandemic response efforts 1.

1See White House Office of Science and Technology Policy (OSTP), American Pandemic Preparedness: Transforming our Capabilities, September 2021, https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf.

To expand ongoing COVID-19 mRNA vaccine supply, as well as build pandemic preparedness against future infectious disease threats, BARDA is contemplating a substantial investment to partner with one or more experienced firms to bolster U.S.-based production capabilities with proven mRNA vaccine manufacturing technology for domestic and global use.

The contemplated requirement will focus on targeted investments to rapidly scale-up, scale-out, and/or otherwise intensify U.S.-based mRNA vaccine drug substance manufacturing capacity.

Investments being considered may involve costs associated with infrastructure (facilities/equipment), bolstering trained staff and long-term sustainment (‘readiness’) for COVID-19 vaccine, or variants of concern, and emerging infectious disease/ pandemic response at no less than 100 million doses per month over and above current U.S.-based capacity.

These contemplated mRNA vaccine drug substance capacity investments are expected to realize the requisite surge manufacturing capabilities no later than fourth quarter 2022. Other potential approaches and innovations that would further accelerate bolstering mRNA vaccine development and manufacturing are also of great interest to the USG.

Interested firms are requested to submit company contact information and responses that capture the following elements:

Brief description (10 pages or less) of company experience and existing infrastructure related to manufacture and supply of mRNA vaccine drug substances, plus additional pages comprising:

  • Discussion/perspective on potential barriers (financial, technological, legal, etc.) to, and/or concerns over, meeting the contemplated objective(s) and timeline;
  • Perspective on granting the USG access/rights to USG-funded infrastructure and technologies on a preferential basis (“priority access”) in the event of a declared public health emergency (PHE);
  • Perspective on cost sharing capital investments in support of U.S.-based capacity expansion objectives;
  • Perspective on sustainment of pandemic response capacities/capabilities during non-pandemic periods;
  • Perspective on “preferred USG pricing” if vaccine doses were to be used to support global response efforts and support low- to middle-income countries.

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY.

NO SOLICITATION CURRENTLY EXISTS.

BARDA will use this information to guide decisions and plans regarding bolstering US-based mRNA vaccine manufacturing capabilities, and to establish a contact list of potential industry participants for future outreach efforts. Please note that contractors performing advisory and assistance services that support BARDA will have access to any submission under this RFI. Please do not include proprietary information in response to this RFI without appropriate markings.

HHS BARDA POC: Mike Angelastro; michael.angelastro@hhs.gov ; 202-260-1887 [desk]; 202-868-9647 [mobile]

Closing Date: Monday, December 13, 2021 at 16:00 EST

pdf icon Download Full RFI
BARDA’s COVID-19
Domestic MCM Manufacturing Capacity 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.

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