This Government Contract opportunity from Department Of Health And Human Services was posted on May 18, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Non-Clinical Safety and Toxicology Studies

Closed

Federal

Submission Closed06/02/2026, 07:00:00 PM UTC

Contract Overview

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

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NAICS: 541714

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Triad - DOE Contractor

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Contact Activation Pathway Function Blocking Antibody AB023The Defense Health Agency is conducting a Request for Information (RFI) to gather market intelligence and identify qualified sources for the supply of the contact activation pathway function blocking antibody AB023, also known as Xisomab 3G3 or Gruticibart. This antibody is designed to inhibit Coagulation Factor XI (FXI) by targeting the "apple 2" domain, preventing its activation by activated factor XII (FXIIa) in the contact pathway, which is implicated in clot formation on artificial surfaces. The antibody is intended for use in medical applications such as Extracorporeal Membrane Oxygenation (ECMO) circuits, hemodialysis, catheters, and cancer-associated thrombosis. It is designed to preserve natural clotting processes by not interfering with FXI activation by thrombin or the conversion of Factor IX by activated FXI, thus maintaining normal hemostasis required for wound healing. The Government anticipates procuring up to 0.5 grams of AB023 annually and requires pharmacokinetic and pharmacodynamic testing to assess its concentration over time, biochemical impacts, clotting time effects, and ability to prevent thrombus growth and fibrin accumulation in vascular thrombosis models. Stability, dosage, and potency validations must be conducted using clotting assays. Although this announcement does not represent a solicitation or obligation to award a contract, interested parties with relevant expertise must submit technical information by June 18, 2026. All responders must be registered in the System for Award Management (SAM). The associated NAICS code is 541714, reflecting research and development in biotechnology. The point of contact is based at the Defense Health Agency in Fort Detrick, Maryland, with the place of performance listed in Texas.

Defense Health Agency

POSTED

5 days ago

DEADLINE

in 1 day

AI Contract Overview

This contract involves conducting non-clinical safety and toxicology studies, specifically focusing on toxicology, pharmacokinetics, and safety pharmacology assessments. These studies are designed to support Investigational New Drug (IND), New Drug Application (NDA), or Biologics License Application (BLA) submissions for radiological medical countermeasures (MCMs). The work will help ensure the safety and efficacy of these countermeasures as part of the regulatory review process. Issued by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases under the Department of Health and Human Services, this subcontract is categorized under the NAICS code 541714, indicating research and development in biotechnology. The contract was posted on May 18, 2026, with responses due by June 2, 2026. While specific location and point of contact details are not provided, the contract emphasizes the critical role of preclinical studies in advancing radiological MCMs through the regulatory pathway.

General Info

Conduct non-clinical safety, toxicology, and pharmacokinetics studies for radiological MCM regulatory approval.

Agency

Department Of Health And Human Services → National Institutes Of Health Niaid

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)View NAICS

Place of Performance

MD, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PhaseClosed

PostedMay 18

subcontract

Response DeadlineJun 2

Deadline has passed

Submission Closed

06/02/2026, 07:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Niaid

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health Niaid

Office AddressN/A

ContactsNo contact information available

Full Description

Perform toxicology, pharmacokinetics, and safety pharmacology studies to support IND, NDA, or BLA submissions for radiological MCMs.