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A--Malaria Vaccine Research and Development

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W911QY15CMVRDFederal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The U.S. Army Contracting Command, Aberdeen Proving Ground, through the Natick Contracting Division, intends to award a Cost Plus Fixed Fee contract on a sole source basis to Sanaria, Inc. for the development of an innovative manufacturing process for a malaria vaccine. This vaccine is based on irradiated, aseptic, purified, cryopreserved, attenuated, and metabolically active Plasmodium falciparum sporozoites derived from mosquitoes. The focus is to scale up manufacturing in compliance with current Good Manufacturing Practices (cGMP) to support Phase 3 clinical trials, ensuring the production of large quantities of vaccine for intravenous administration. Sanaria, Inc., a small business located in Rockville, MD, is recognized as the sole responsible source due to its unique position in developing this specific type of malaria vaccine, making it the only vendor qualified to fulfill this requirement. The contract aligns with NAICS code 541711 and emphasizes the critical need for a large-scale automated manufacturing process capable of meeting stringent regulatory standards. The synopsis for this opportunity was posted in June 2015, with inquiries directed to the designated point of contact within the contracting command.

General Info

Award to Sanaria, Inc. for cGMP-compliant malaria vaccine manufacturing supporting Phase 3 trials.

Agency

Department Of Defense → W6QK Acc-Apg Natick

NAICS

541711 - Research and Development in Biotechnology

Place of Performance

Set-Aside

NONE

Documents

No documents available

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Uniform Contract Format

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Timeline

PostedJun 8

special-notice

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Organization & Contact Information

AgencyDepartment Of Defense → W6QK Acc-Apg Natick

ContactsNo contacts available

OfficeNATICK, MA, 01760-5011, USA

Organization / AgencyDepartment Of Defense → W6QK Acc-Apg Natick

Office AddressNATICK, MA, 01760-5011, USA

ContactsNo contact information available

Full Description

SYNOPSIS: The U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division (NCD), on behalf of the Advanced Medical Development (AMD) Program Office of Naval Medical Research Center (NMRC), intends to award a Cost Plus Fixed Fee contract on a sole source basis to Sanaria, Inc., for the development of an improved manufacturing process of an irradiated sporozoites-based malaria vaccine to support large scale manufacturing for use in Phase 3 clinical trials. The requirement calls for the development of a large scale automated manufacturing process that is compliant with current Good Manufacturing Practices (cGMPs) that will produce large amounts of malaria vaccine to be utilized in future Phase 3 clinical trials. The vaccine must utilize irradiated aseptic, purified, cryopreserved, attenuated (non-replicating), metabolically active Plasmodium falciparum (Pf) sporozoites (SPZ) extracted from mosquitos that are grown and incubated. In addition, the vaccine must be administered intravenously. Sanaria, Inc., a small business located in Rockville, MD is the only responsible source for this effort based on Market Research, and Sanaria, Inc. is the only vendor that is developing a malaria vaccine utilizing irradiated aseptic, purified, cryopreserved, attenuated (non-replicating), metabolically active Plasmodium falciparum (Pf) sporozoites (SPZ) extracted from mosquitos that are grown and incubated. As such, this contract will be awarded to Sanaria, Inc. The applicable NAICS code is 541711 with a size standard of 500 employees. This synopsis expires on June 23, 2015, 3:30PM EST. Please direct any questions to Shawn Haubner at contact@example.gov.