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Advanced Freeze Dryer

Active

Federal

Contract Overview

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

AI Contract Overview

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The Food and Drug Administration is seeking an advanced freeze dryer to support the Office of Pharmaceutical Quality Research in its evaluation of complex generics, biologics, and essential medicines. This equipment will feature advanced process monitoring and control capabilities to assist in the assessment of manufacturing quality and the development of science-based regulatory standards. The acquisition aims to strengthen the agency's ability to ensure the safety, efficacy, and quality of lyophilized drugs, which include a significant portion of FDA-approved antibiotics and injectable medications. This capability will directly support facility inspections, staff training, guidance development, and the overall review process for new and generic drug products.

General Info

FDA seeks an advanced freeze dryer to evaluate complex generics and biologics quality.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

333415 - Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

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Timeline

PostedJan 1

forecast

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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Approximately 70% of FDA-approved antibiotics and most injectable drugs use lyophilization (freeze-drying) during manufacturing. OPQR conducts lyophilization research to support review of generic and new drugs, facility inspections, staff training, and guidance development for these critical drug products. The proposed equipment will support complex generics, biologics, and essential medicine manufacturing and product quality research. The lyophilizer with advanced process monitoring and control capabilities will support assessment of manufacturing quality, develop science-based regulatory standards. This equipment will strengthen FDA's ability to ensure the safety, efficacy, and quality of lyophilized drugs that reach patients.

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