$573,900
COVETRUS NORTH AMERICA, LLC
Animal and Plant Health Inspection Service
- PIID
- 12639526C0032
- PSC
- 6509 - DRUGS AND BIOLOGICALS, VETERINARY USE
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
- $135.6B
- Total awards
- 14,679 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
- $132.7M
- Awards
- 331
- Average award
- $401K
- Change from FY2024
- -92.6%
Federal obligation trend
FY2021
$4.2B · 248 awards
FY2022
$4.6B · 556 awards
FY2023
$8.6B · 542 awards
FY2024
$1.8B · 466 awards
FY2025
$132.7M · 331 awards
FY2026
$74.3M · 88 awards
Recent awards
$206,861
OLINK PROTEOMICS INC
National Institutes of Health
- PIID
- 75N98026P00626
- PSC
- 6505 - DRUGS AND BIOLOGICALS
$174,560
REPLIGEN CORPORATION
Food and Drug Administration
- PIID
- 75F40126P00067
- PSC
- 6640 - LABORATORY EQUIPMENT AND SUPPLIES
$522,030
SOMALOGIC OPERATING CO., INC
National Institutes of Health
- PIID
- 75N98026P00545
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$19,304
LIFE TECHNOLOGIES CORPORATION
National Institutes of Health
- PIID
- 75N98026P00524
- PSC
- 6640 - LABORATORY EQUIPMENT AND SUPPLIES
$22,757
BIOLEGEND, INC.
National Institutes of Health
- PIID
- 75N98026P00519
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$92,585
ILLUMINA, INC.
National Institutes of Health
- PIID
- 75N98026P00474
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$16,488
BIOLEGEND, INC.
National Institutes of Health
- PIID
- 75N98026P00452
- 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.
Put this market knowledge to work
Now that you know about NAICS 325414 - Biological Product (except Diagnostic) Manufacturing, let Sweetspot help you find and win relevant government contracts with AI-powered tools.