Federal NAICS Codes

NAICS 325414: Biological Product (except Diagnostic) Manufacturing

Explore obligations, trends, recent awards, and incumbent contractors for NAICS 325414.

NAICS 325414 federal market metrics

Total obligations
$135.7B
Total awards
14,702 awards
Active obligations
$2.5B
Size standard
1,250 employees

What this NAICS covers

NAICS 325414 covers manufacturing biological products except diagnostics, including production, formulation, fill-finish, sterile processing, batch testing, packaging, and maintaining manufacturing quality records and compliance for biologics produced at commercial facilities.

Federal opportunities under 325414 typically involve supplying government agencies with finished biological products, requiring validated manufacturing processes, batch records, lot release testing, regulatory compliance documentation, cold-chain packaging, and delivery of certified product lots for program use.

FY2025 snapshot

Obligations
$131.9M
Awards
331
Average award
$398.5K
Change from FY2024
-92.6%

Recent awards

Search contractors

$21,835

ACROBIOSYSTEMS INC

National Institutes of Health

PIID
75N98026P01080
PSC
6505 - DRUGS AND BIOLOGICALS

$27,446

EMD MILLIPORE CORP

National Institutes of Health

PIID
75N98026P00978
PSC
6505 - DRUGS AND BIOLOGICALS

$15,133

FUJIFILM BIOSCIENCES INC.

Food and Drug Administration

PIID
75F40126F19002
PSC
B529 - SPECIAL STUDIES/ANALYSIS- SCIENTIFIC DATA

$248,906

JACKSON LABORATORY

National Institutes of Health

PIID
75N98026P00914
PSC
6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS

$977

BIOMERIEUX INC

Food Safety and Inspection Service

PIID
123A9426F0069
PSC
6640 - LABORATORY EQUIPMENT AND SUPPLIES

FAQ

What work fits NAICS 325414?
  • Commercial-scale sterile fill/finish operations for vaccine or biologic drug product lots including aseptic processing and primary container sealing.
  • Bulk upstream production of cell-culture or fermentation-derived active biological ingredients with process monitoring and waste biosafety handling.
  • Contract manufacturing organization services for regulated biologics, including batch record management, stability storage, and lot release support.
  • Transfer and scale-up of lab processes to GMP production, establishing validated manufacturing runs and documentation for regulatory submissions.
When is NAICS 325414 a weak fit?
  • Diagnostic device or in vitro test manufacturing: work limited to producing test kits, assay cartridges, or clinical diagnostic reagents that require different regulatory controls and fall outside this NAICS.
  • Research and development laboratories: bench-scale R&D, preclinical assays, or process development without full-scale GMP manufacturing runs or commercial lot production.
  • Biological product testing and analytical laboratory services: stand-alone analytical testing, potency assays, or contract lab testing without responsibility for production or fill-finish manufacturing.
What solicitation language points to NAICS 325414?
  • Requirements list GMP-compliant production suites, validated cleanroom classifications, environmental monitoring data, and sterile filling line qualifications.
  • Deliverables include batch records, change control documentation, cold-chain validated storage and shipping procedures, and lot release certification packages.
  • Performance requirements specify biosafety level controls, hazardous biological waste handling, and validated sterilization or depyrogenation processes.

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