325414 - Biological Product (except Diagnostic) Manufacturing
In the rapidly evolving world of manufacturing, NAICS code 325414 stands out as a critical classification for companies involved in producing life-saving and health-enhancing biological products. This sector, known as Biological Product (except Diagnostic) Manufacturing, plays a pivotal role in medical and pharmaceutical industries by supplying vaccines, blood components, and other vital biologics. Whether you're an industry professional, government contractor, or an entrepreneur, understanding this NAICS code is essential for navigating regulatory requirements, contracting opportunities, and market positioning.
What is NAICS Code 325414?
NAICS 325414 specifically describes establishments primarily engaged in manufacturing biological products, except diagnostic substances. This means companies under this code focus on creating biologics used for treatment, prevention, and therapy rather than for diagnostic testing. The product range includes vaccines against numerous diseases, blood derivatives, serums, and gene therapy preparations.
Sector Overview: Manufacturing Biological Products
- Sector: Manufacturing
- Industry Focus: Biological products used in healthcare, excluding diagnostic reagents or kits
- Key Manufacturing Areas:
- Vaccines (bacterial, viral, both)
- Blood components and derivatives
- Serums, antitoxins, antivenoms
- Gene therapy preparations
- Culture media used in life sciences (non-diagnostic)
This sector supports essential public health initiatives, pharmaceutical development, and biopharmaceutical manufacturing, contributing significantly to healthcare innovation.
Size Standards and Eligibility
For small business size standards relevant to NAICS 325414:
- Maximum number of employees: 1,250 employees
This employee cap determines eligibility for small business programs and federal contract set-asides under this NAICS code. Companies exceeding 1,250 employees are considered large businesses for government procurement and regulatory purposes.
Typical Businesses Under NAICS 325414
Organizations that categorize under this NAICS code typically include:
- Vaccine manufacturing companies producing influenza, tetanus, diphtheria, or other bacterial/viral vaccines
- Blood plasma product manufacturers specializing in plasma derivatives or fractions for therapeutic use
- Biopharmaceutical companies producing therapeutic proteins, gene therapy agents, and other biological products (non-diagnostic)
These businesses are fundamental to addressing both routine and emergent public health challenges through innovative biologic therapies.
Detailed Code Activities Table
| Activity Description | Included in NAICS 325414? |
|---|---|
| Agar culture media manufacturing | Yes |
| Aggressins (except in-vitro) manufacturing | Yes |
| Allergenic extracts (except diagnostic substances) | Yes |
| Allergens manufacturing | Yes |
| Antigens manufacturing | Yes |
| Antiserums manufacturing | Yes |
| Antitoxins manufacturing | Yes |
| Antivenoms manufacturing | Yes |
| Bacterial vaccines manufacturing | Yes |
| Bacterins (bacterial vaccines) manufacturing | Yes |
| Blood derivatives manufacturing | Yes |
| Blood fractions manufacturing | Yes |
| Cholera serums manufacturing | Yes |
| Culture media manufacturing | Yes |
| Gene therapy preparations manufacturing | Yes |
| Hematology products (except diagnostic substances) | Yes |
| Plasmas manufacturing | Yes |
| Serums (except diagnostic substances) manufacturing | Yes |
| Toxoids e.g., diphtheria, tetanus manufacturing | Yes |
| Tuberculin manufacturing | Yes |
| Vaccines manufacturing (bacterial & viral) | Yes |
| Virus vaccines manufacturing | Yes |
Frequently Asked Questions (FAQ)
What products are manufactured under NAICS 325414?
Businesses in this category produce vaccines, blood products, antitoxins, antivenoms, serums, gene therapies, and culture media—all biologicals except those designed for diagnostic purposes.
How is NAICS 325414 different from diagnostic manufacturing?
NAICS 325414 excludes diagnostic substances such as testing reagents and diagnostic kits, which fall under a different NAICS code. It focuses on biologics intended for treatment and prevention.
What is the small business size standard for this industry?
The U.S. Small Business Administration sets the maximum employee count at 1,250 employees for small business eligibility under this NAICS code.
Can biotech companies manufacturing therapeutic proteins fall under NAICS 325414?
Yes, biopharmaceutical companies producing therapeutic proteins (excluding diagnostics) are classified under this NAICS code.
Are vaccines for animals included?
No, this code primarily covers human biological products. Veterinary biologics usually fall under another classification.
Conclusion
NAICS code 325414 - Biological Product (except Diagnostic) Manufacturing defines a critical niche within the manufacturing sector focused on developing groundbreaking biological products that directly influence human health. From vaccine makers to plasma product manufacturers, companies under this NAICS serve a vital role in the healthcare supply chain. Understanding this code not only helps businesses identify relevant markets and federal opportunities but also emphasizes the essential nature of biologics manufacturing in advancing global healthcare.
For businesses and professionals operating in this sector, mastering the specifics of NAICS 325414 is a strategic advantage in compliance, bidding, and growth within the dynamic field of biological product manufacturing.
