SPECIAL NOTICE
A -- Domestic Manufacturing Capacity Expansion
- Notice Date
- 7/24/2020 4:59:09 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W6QK ACC-APG NATICK NATICK MA 01760-5011 USA
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-20-S-0018
- Response Due
- 10/31/2020 5:00:00 PM
- Archive Date
- 11/15/2020
- Point of Contact
- John Conlin
- E-Mail Address
-
john.conlin3.civ@mail.mil
(john.conlin3.civ@mail.mil)
- Description
- Background. The HHS Biomedical Advanced Research Development Authority (BARDA) in conjunction with the DoD Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) has a need to expand the domestic manufacturing capacity for vaccine consumables products, in support of the US Government's COVID-19 response. Interested parties operating in this sector are encouraged to submit a preproposal through the JPEO CBRND Medical Countermeasures Broad Agency Announcement, W911QY-17-S-0001, describing their interest and capability to partner with the JPEO CBRND via a Technology Investment Agreement under the authority of 10 U.S.C. 2371.� Description of Need. General Objectives: The recipient shall expand existing domestic Continental US (CONUS) based manufacturing capacity for COVID-19 vaccine consumables products. The recipient shall identify, develop and qualify new US-based manufacturing capacity for utilization with USG (BARDA and affiliate partners) COVID-19 vaccines.� Expansion of existing domestic capacity shall be through expansion of manufacturing capabilities in existing and new recipient facilities. ������� Specific Objectives: 1. The recipient shall develop a vaccine consumables manufacturing capacity and production solution to provide a long term capability. This expanded capacity shall enable surge production of parenteral drug product capacity, to support the US Government's COVID-19 response and future pandemic or other critical situations.� The recipient shall undertake all necessary activities to build out and expand capacity at its domestic manufacturing facilities.� 2. Manufacturing capacity expansion shall be for vaccine consumables products including, but not limited to: . Cell Culture Media . Bioreactors and Mixers Bags . Single Use Consumables 3. Manufacturing capacity expansion shall be capable of supporting projected 3rd party demand for consumables products from current BARDA sponsored COVID-19 vaccine developers through 2022, to specifically include the current surge requirement for the US domestic response to COVID-19.� 4. The recipient shall ensure compliance with all Federal safety and health regulations and ensure Food and Drug Administration (FDA) approval upon completion of the effort for all of the new capacity. BARDA will support the recipient's requests for assistance in navigating and streamlining federal requirements to the maximum practical extent. How to submit a preproposal. Interested parties should submit preproposals in accordance with Section III.F. and IV.C. Preproposals shall include technical details describing the type and amount of capacity increase envisioned, timeline to achieve that increase, a rough order of magnitude cost to achieve the increase, and the degree of cost sharing expected from the US Government. Questions may be submitted to John Conlin at john.conlin3.civ@mail.mil.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/1959e15d9a174b93adde502a35c77a9c/view)
- Record
- SN05732634-F 20200726/200724230142 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |