Tools commonly used in the Biological Specimens (Manufacturing) industry for day-to-day tasks and operations.

• Bioreactors
• Microscopes
• Centrifuges
• Pipettes
• Incubators
• Freezers
• Cryogenic storage tanks
• Cell culture plates
• Petri dishes
• Microtomes
• Microinjectors
• Electrophoresis equipment
• PCR machines
• Spectrophotometers
• Flow cytometers
• Liquid handling robots
• Microarray scanners
• Gel documentation systems
• Automated cell counters

Common products and services typical of NAICS Code 325414-02, illustrating the main business activities and contributions to the market.

• Tissue samples
• Blood samples
• Bacterial cultures
• Yeast cultures
• Cell lines
• DNA samples
• RNA samples
• Protein samples
• Antibodies
• Viral vectors
• Microbial strains
• Parasite specimens
• Fungal specimens
• Insect specimens
• Plant specimens
• Animal specimens
• Human specimens
• Stem cells
• Embryonic cells
• Cancer cells

The specific certifications, permits, licenses, and regulatory compliance requirements within the United States for this industry.

• Good Manufacturing Practice (GMP): GMP is a set of regulations enforced by the FDA to ensure that products are consistently produced and controlled according to quality standards. This certification is required for the manufacturing of biological specimens. The FDA provides guidance on GMP compliance:
• Clinical Laboratory Improvement Amendments (CLIA): CLIA certification is required for any laboratory that performs testing on human specimens for the purpose of diagnosis, prevention, or treatment of disease. This certification is required for the manufacturing of biological specimens. The Centers for Medicare & Medicaid Services (CMS) provides guidance on CLIA certification:
• Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard: This standard requires employers to protect workers who are occupationally exposed to blood or other potentially infectious materials. This certification is required for the manufacturing of biological specimens. OSHA provides guidance on the Bloodborne Pathogens Standard:
• International Organization for Standardization (ISO) 13485: ISO 13485 is a quality management system standard for medical devices. This certification is not required for the manufacturing of biological specimens, but it can be beneficial for companies that manufacture medical devices that use biological specimens. The International Organization for Standardization provides guidance on ISO 13485:
• College Of American Pathologists (CAP) Accreditation: CAP accreditation is a voluntary certification for laboratories that perform diagnostic testing. This certification is not required for the manufacturing of biological specimens, but it can be beneficial for companies that manufacture diagnostic products that use biological specimens. The College of American Pathologists provides guidance on CAP accreditation:

A concise historical narrative of NAICS Code 325414-02 covering global milestones and recent developments within the United States.

• The Biological Specimens Manufacturing industry has a long history dating back to the 19th century when the first biological specimens were collected and preserved for scientific research. In the early 1900s, the industry experienced significant growth due to the increasing demand for biological specimens in medical research and education. Notable advancements in the industry include the development of new preservation techniques, such as cryopreservation, which allows for the long-term storage of biological specimens. In recent years, the industry has seen a surge in demand for biological specimens for use in genetic research, drug development, and personalized medicine. In the United States, the industry has been impacted by the COVID-19 pandemic, with increased demand for biological specimens for use in diagnostic testing and vaccine development.

The anticipated future trajectory of the NAICS 325414-02 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

• Growth Prediction: Growing

  The future outlook for the Biological Specimens (Manufacturing) industry in the USA is positive. The industry is expected to grow due to the increasing demand for biological specimens in research and development activities in the healthcare sector. The advancements in technology and the increasing focus on precision medicine are also expected to drive the growth of the industry. Additionally, the COVID-19 pandemic has highlighted the importance of biological specimens in the development of vaccines and treatments, which is expected to further boost the demand for the industry. However, the industry may face challenges such as regulatory hurdles and ethical concerns related to the collection and use of biological specimens.

Recent groundbreaking advancements and milestones in the Biological Specimens (Manufacturing) industry, reflecting notable innovations that have reshaped its landscape.

• Development Of 3D Bioprinting Technology: This technology allows the creation of complex biological structures, including tissues and organs, which can be used for research and drug testing purposes.
• Use Of CRISPR Gene Editing Technology: This technology allows the modification of genes in biological specimens, which can be used to study the effects of genetic mutations and develop new treatments for genetic diseases.
• Development Of Liquid Biopsy Tests: These tests use biological specimens such as blood or urine to detect cancer and other diseases at an early stage, which can improve patient outcomes.
• Use Of Artificial Intelligence In Specimen Analysis: AI can be used to analyze large amounts of data from biological specimens, which can help identify new biomarkers and develop personalized treatments.
• Development Of Biobanks: Biobanks are repositories of biological specimens that can be used for research purposes. The development of biobanks has facilitated research in various fields, including genomics, proteomics, and drug discovery.