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Manufacturing of Clinical-Grade Materials (CMC)

Active
SBIR / STTR

Contract Overview

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

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This subcontract opportunity with the Department of Health and Human Services focuses on the manufacturing of clinical-grade materials for CMC purposes. The primary objective is to produce GMP-compliant biologic drug substances or device components intended for use in early-phase clinical trials, utilizing processes that are designed to be scalable. The solicitation is designated as a total small business set-aside under the SBIR/STTR mandate, requiring contractors to have fewer than 500 employees. It falls under NAICS code 325412, with a posting date of May 28, 2026, and a response deadline of April 6, 2027.

General Info

HHS small business subcontract for manufacturing GMP-compliant clinical-grade biologic drug substances.

Agency

Department of Health and Human ServicesView Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

Not specified

Set-Aside

SBA

Documents

This scope was carved out of PA-27-100.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)

AI Contract Breakdown

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Timeline

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Response Deadline

Submission deadline

Response Deadline

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Organization & Contact Information

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AgencyDepartment of Health and Human Services
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department of Health and Human Services
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Office AddressN/A
ContactsNo contact information available

Full Description

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Produce GMP-compliant biologic drug substances or device components for use in early-phase clinical trials with scalable processes.

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