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Scalable Biologic Manufacturing and Formulation

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Contract Overview

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This subcontract focuses on the development of CMC strategies and scalable production processes for biologic therapies supporting prime contractors on NIH/NINDS projects. The scope of work involves utilizing bioreactors and cleanroom facilities to establish manufacturing processes and formulation strategies, ensuring that all quality attributes are validated in accordance with GMP and regulatory standards for clinical application. The successful provider will be responsible for delivering comprehensive scalable manufacturing documentation, formulated drug products, and detailed quality specifications. This effort is managed under the National Institutes of Health within the Department of Health and Human Services, falling under NAICS code 325414 for biologic product manufacturing.

General Info

Subcontract for CMC strategies and scalable biologic production processes for NIH/NINDS projects.

Agency

Department Of Health And Human Services → National Institutes Of Health

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of RFA-NS-28-012.

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

View the prime solicitation

Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)

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Timeline

Posted

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Submission deadline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressN/A
ContactsNo contact information available

Full Description

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Develops CMC strategy and scalable production processes for biologic therapies for prime contractors on NIH/NINDS projects. Develops manufacturing processes and formulation strategies using bioreactors and cleanroom facilities. Validates quality attributes aligned with GMP and regulatory expectations for clinical use. Delivers scalable manufacturing documentation, formulated drug product, and quality specifications.

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Same NAICS industry code

NAICS: 325414
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Mrpbs Minneapolis Mn

POSTED

8 days ago

DEADLINE

in 6 days
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