Tools commonly used in the Serums & Vaccines (Manufacturing) industry for day-to-day tasks and operations.

• Bioreactors
• Centrifuges
• Chromatography systems
• Fermenters
• Incubators
• Lyophilizers
• Microscopes
• Pipettes
• Spectrophotometers
• Ultrafiltration systems

Common products and services typical of NAICS Code 325414-04, illustrating the main business activities and contributions to the market.

• Influenza vaccine
• Measles vaccine
• Polio vaccine
• Rabies vaccine
• Tetanus vaccine
• Yellow fever vaccine
• Anti-venom serum
• Antitoxin serum
• Hepatitis B vaccine
• Meningococcal vaccine

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

• Biologics License Application (BLA): A BLA is required by the FDA for the approval of biological products, including vaccines and serums, for use in humans. The application includes information on the manufacturing process, clinical data, and labeling. The FDA reviews the application to ensure that the product is safe and effective.
• Good Manufacturing Practices (GMP): GMP regulations ensure that biological products are consistently produced and controlled according to quality standards. Compliance with GMP regulations is required for the manufacture of vaccines and serums. The FDA enforces GMP regulations through inspections of manufacturing facilities.
• ISO 13485: ISO 13485 is an international standard for the quality management system of medical devices, including vaccines and serums. Compliance with ISO 13485 demonstrates that a company has implemented a quality management system that meets international standards.
• Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard: The OSHA Bloodborne Pathogens Standard requires employers to protect workers who may be exposed to blood or other potentially infectious materials. This standard applies to workers in the vaccine and serum manufacturing industry who may come into contact with blood or other biological materials.
• National Institute for Occupational Safety and Health (NIOSH) Respiratory Protection Standard: The NIOSH Respiratory Protection Standard requires employers to provide respiratory protection to workers who may be exposed to airborne contaminants, including those in the vaccine and serum manufacturing industry.

A concise historical narrative of NAICS Code 325414-04 covering global milestones and recent developments within the United States.

• The manufacturing of serums and vaccines has a long and rich history dating back to the late 18th century when Edward Jenner developed the first vaccine for smallpox. Since then, the industry has made significant advancements, including the development of vaccines for various diseases such as polio, measles, and influenza. In the early 20th century, the industry saw a significant boost with the discovery of antibiotics, which led to the development of new vaccines and treatments. In recent years, the industry has been at the forefront of developing vaccines for emerging diseases such as Ebola, Zika, and COVID-19. In the United States, the industry has seen significant growth in the past decade, with the approval of new vaccines and the expansion of production facilities.

The anticipated future trajectory of the NAICS 325414-04 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 Serums & Vaccines (Manufacturing) industry in the USA is positive due to the increasing demand for vaccines and the ongoing research and development of new vaccines. The COVID-19 pandemic has highlighted the importance of vaccines and has led to increased investment in vaccine research and development. The industry is also expected to benefit from the growing aging population and the increasing prevalence of chronic diseases. However, the industry may face challenges such as regulatory hurdles, supply chain disruptions, and competition from generic drugs. Overall, the industry is expected to grow in the coming years due to the increasing demand for vaccines and the ongoing research and development of new vaccines.

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

• Pfizer-Biontech COVID-19 Vaccine: The Pfizer-BioNTech COVID-19 vaccine was developed in record time and has been authorized for emergency use in the USA. The vaccine uses messenger RNA (mRNA) technology and has shown to be highly effective in preventing COVID-19.
• Moderna COVID-19 Vaccine: The Moderna COVID-19 vaccine is another mRNA-based vaccine that has been authorized for emergency use in the USA. The vaccine has shown to be highly effective in preventing COVID-19 and has been well-tolerated in clinical trials.
• Johnson & Johnson COVID-19 Vaccine: The Johnson & Johnson COVID-19 vaccine is a viral vector-based vaccine that has been authorized for emergency use in the USA. The vaccine has shown to be highly effective in preventing severe COVID-19 and has the advantage of requiring only one dose.
• Novavax COVID-19 Vaccine: The Novavax COVID-19 vaccine is a protein subunit vaccine that is currently in phase 3 clinical trials. The vaccine has shown to be highly effective in early clinical trials and has the advantage of being stable at normal refrigerator temperatures.
• MRNA Technology: The development of mRNA technology has revolutionized the vaccine industry and has led to the rapid development of COVID-19 vaccines. mRNA technology has the potential to be used in the development of vaccines for other infectious diseases and even cancer.
• Gene Editing: Gene editing technologies such as CRISPR-Cas9 have the potential to be used in the development of new vaccines. Gene editing can be used to modify viruses and bacteria to make them less virulent or to produce antigens that can be used in vaccines.
• Adjuvants: Adjuvants are substances that can be added to vaccines to enhance the immune response. The development of new adjuvants can improve the efficacy of vaccines and reduce the amount of antigen needed in each dose.
• Personalized Vaccines: Personalized vaccines can be tailored to an individual's specific immune system and can potentially provide better protection against infectious diseases. The development of personalized vaccines is still in the early stages but has the potential to revolutionize the vaccine industry.
• Vaccine Storage and Distribution: The development of new technologies for vaccine storage and distribution can improve access to vaccines in remote and underserved areas. Technologies such as freeze-drying and micro-needle patches can improve the stability and ease of use of vaccines.
• Vaccine Hesitancy: Vaccine hesitancy is a growing concern and can potentially undermine the success of vaccination programs. The development of new strategies for vaccine education and communication can help to address vaccine hesitancy and improve vaccine uptake.