NAICS 325414 - Biological Product (except Diagnostic) Manufacturing
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What is NAICS 325414
NAICS code 325414 covers establishments primarily engaged in the manufacturing of biological products excluding diagnostic items. This sector includes companies that produce vaccines, toxoids, blood fractions, and culture media derived from plant or animal origins. Businesses operating under this code play a critical role in public health by providing essential biological materials for disease prevention, treatment, and research. The manufacturing processes often involve advanced biotechnology and strict regulatory compliance, ensuring the safety and efficacy of products. Government agencies contract with these manufacturers to secure reliable supplies of vaccines and biological therapeutics, which are vital for national health security and emergency preparedness. The sector’s focus on innovation and high standards makes it a key partner in government healthcare initiatives and biodefense programs.
Industry Classification for NAICS 325414
This U.S. industry comprises establishments primarily engaged in manufacturing vaccines, toxoids, blood fractions, and culture media of plant or animal origin (except diagnostic).
Breakdown for NAICS 325414
- Manufacturing of vaccines, toxoids, blood fractions, and culture media from biological sources.
- Excludes diagnostic biological product manufacturing.
- Includes establishments compliant with FDA regulations and Good Manufacturing Practices.
- Typical contract sizes range from small R&D projects to multi-million dollar supply agreements.
- Critical for supporting national immunization and biodefense programs.
- Businesses must maintain high standards for safety, quality, and regulatory compliance.
Included Activities for NAICS 325414
- Vaccine production and formulation.
- Manufacture of toxoids and immunological agents.
- Processing and preparation of blood fractions.
- Development of culture media for biological research and production.
- Quality control and assurance testing of biological products.
- Regulatory compliance and validation activities.
- Packaging and distribution of biological products for government use.
- Research and development related to new biological therapeutics.
Business Types for NAICS 325414
- Biotechnology firms specializing in vaccine development.
- Pharmaceutical manufacturers producing biological products.
- Contract manufacturing organizations (CMOs) focusing on biologics.
- Government contractors with expertise in GMP-compliant production.
- Research institutions engaged in biologics manufacturing.
- Specialized blood product manufacturers.
Subcategories for NAICS 325414
- Agar culture media manufacturing
- Aggressins (except in-vitro) manufacturing
- Allergenic extracts (except diagnostic substances) manufacturing
- Allergens manufacturing
- Antigens manufacturing
- Antiserums manufacturing
- Antitoxins manufacturing
- Antivenoms manufacturing
- Bacterial vaccines manufacturing
- Bacterins (i.e., bacterial vaccines) manufacturing
- Blood derivatives manufacturing
- Blood fractions manufacturing
- Cholera serums manufacturing
- Culture media manufacturing
- Gene therapy preparations manufacturing
- Hematology products (except diagnostic substances) manufacturing
- Plasmas manufacturing
- Serums (except diagnostic substances) manufacturing
- Toxoids (e.g., diphtheria, tetanus) manufacturing
- Tuberculin (i.e., tuberculo-protein derived) manufacturing
- Vaccines (i.e., bacterial, virus) manufacturing
- Virus vaccines manufacturing
Government Buyers for NAICS 325414
Federal agencies such as the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the Department of Defense (DoD), and the Biomedical Advanced Research and Development Authority (BARDA) are primary buyers of products under NAICS 325414. These agencies require biological products for national immunization programs, pandemic response, military readiness, and public health protection. Contracts often support stockpiling vaccines and biological agents for emergency use, as well as ongoing research and development activities to combat emerging infectious diseases. State and local health departments also procure these products to implement vaccination campaigns and public health initiatives.
Contract Types & Procurement for NAICS 325414
Contracts in this sector commonly include fixed-price, cost-plus, and indefinite-delivery/indefinite-quantity (IDIQ) agreements. Procurement methods often involve competitive bidding, negotiated contracts, and sole-source awards in cases of specialized or urgent needs. Contract values can vary widely, from small-scale research and development contracts to multi-million-dollar procurement agreements for vaccine manufacturing and supply. Long-term contracts and partnership agreements are frequent due to the need for continuous production, quality assurance, and regulatory compliance. Government contracting officers emphasize adherence to Good Manufacturing Practices (GMP) and timely delivery schedules in awarding contracts under this NAICS code.
Details for NAICS 325414
Explore the hierarchy and related codes for this industry
| NAICS Code | Industry Title |
|---|---|
| 32541 | Pharmaceutical and Medicine Manufacturing |
| 3254 | Pharmaceutical and Medicine Manufacturing |
| 325 | Chemical Manufacturing |
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