Artificial Intelligence and Computational Statistics Platform for Biosimilar Subvisible Characterization
Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF.FOOD AND DRUG ADMINISTRATION.FDA OFFICE OF ACQ GRANT SVCS
Location
Silver Spring, MD
Maryland
Estimated Value
N/A
Type
Combined Synopsis/Solicitation
Service / NAICS
513210
Set-Aside
NONE
Opportunity Summary
This federal contract opportunity from HEALTH AND HUMAN SERVICES, DEPARTMENT OF.FOOD AND DRUG ADMINISTRATION.FDA OFFICE OF ACQ GRANT SVCS involves artificial intelligence and computational statistics platform for biosimilar subvisible characterization in Silver Spring, Maryland. This is a NONE set-aside procurement. Responses are due by May 26, 2026 (13 days remaining).
Contract Description
The Food and Drug Administration’s Office of Product Quality Research (OPQR) require a machine learning (ML/AI) and computational statistics platform with associated services to detect and classify protein aggregates in biosimilar drug products. This capability will support a feasibility study assessing the utility of artificial intelligence/machine learning and computational statistical analysis for biosimilar comparability assessment, quality assessment, and quality surveillance. The platform: • Shall combine machine learning to generate morphological fingerprints of protein aggregates • Shall generate morphological fingerprints specific to product and underlying stress or mechanism of aggregation • Shall be able to differentiate particles from different stress types, the product, and co...
Timeline
Posted Date
May 11, 2026
Response Deadline
May 26, 2026
13 days remaining
What Contractors Should Know
This is a NONE set-aside, meaning only qualifying small businesses may compete.
Work will be performed in Silver Spring, Maryland. Local presence or experience in this area can strengthen your proposal.
Should You Pursue This?
Good Fit If…
- ✓You hold the required NONE certification
- ✓You have operations or past performance in Maryland
- ✓You have worked with HEALTH AND HUMAN SERVICES, DEPARTMENT OF.FOOD AND DRUG ADMINISTRATION.FDA OFFICE OF ACQ GRANT SVCS before
Harder to Win If…
- !Only 13 days remaining to prepare your response
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Contractor FAQ
What certifications are needed for this NONE contract?
This opportunity requires NONE certification. Contractors must be registered and certified in SAM.gov with the appropriate small business designation to be eligible to submit proposals.
How do I submit a bid for this HEALTH AND HUMAN SERVICES, DEPARTMENT OF.FOOD AND DRUG ADMINISTRATION.FDA OFFICE OF ACQ GRANT SVCS contract?
To bid on this opportunity, you must be registered in SAM.gov. Review the full solicitation documents available at SAM.gov, prepare your technical and cost proposals per the instructions, and submit before the response deadline of May 26, 2026.
Are there other federal contract opportunities in Maryland?
Yes. RecompeteIQ tracks federal contract opportunities across Maryland, including active solicitations and upcoming recompetes. Visit our Maryland contracts page for a full list of current opportunities in this area.
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Original listing: View on SAM.gov