Biological Sciences
Vaccine Manufacturing
Vaccine manufacturing involves the production of vaccines, which are biological preparations that provide immunity against specific diseases. The process typically includes growing the disease-causing organism, inactivating or attenuating it, and formulating it into a vaccine. Quality control and regulatory compliance are crucial aspects of vaccine manufacturing to ensure safety and efficacy.
Written by Perlego with AI-assistance
Related key terms
1 of 5
7 Key excerpts on "Vaccine Manufacturing"
eBook - PDF- Myrone M. Levine, Myron M. Levine, Gordon Dougan, Michael F. Good, Margaret A. Liu, Gary J. Nabel, James P. Nataro, Rino Rappuoli, Myrone M. Levine, Myron M. Levine, Gordon Dougan, Michael F. Good, Gary J. Nabel, James P. Nataro, Rino Rappuoli, Myrone M. Levine, Myron M. Levine, Gordon Dougan, Michael F. Good, Gary J. Nabel, James P. Nataro, Rino Rappuoli(Authors)
- 2016(Publication Date)
- CRC Press(Publisher)
The entire process may take from one to two years to manufacture and release a vaccine (1), although production can be fast-tracked, for example, for biodefense products or the annual formulation of influenza vaccines. Raw Materials All raw materials must come from reliable sources and be shown to meet specifications. Most manufacturers use supplier qualification coupled with some quarantine release tests for this purpose. The primary raw materials for biological products, such as seeds, cells, and biological fluids are subject to intense documentation and testing measures, to ensure both consistent characteristics and freedom from adventitious or potentially harmful agents. Bulk Manufacture Production should occur in dedicated laboratory suites with biologically inactive (prior to infection or after inactivation) areas segregated from production areas in which active materi-als are being processed. Physical barriers and pressurized air locks are used to prevent cross-contamination of the product; in addition, air and effluents must not contain viruses or bacteria that could contaminate the environment. Seed Preparation Master and working seed bank systems are generally used to initiate manufacture. The bacterial or viral seed is obtained with a well-documented history and is stored in an appropriate manner. Bacterial Fermentation Although fermentation generally refers to the process of grow-ing bacteria in large-volume-closed systems, fermentation This is a revision and update of the chapter in the previous edition of this volume: Milstien J, Stephenne J, Gordon L. A primer on large-scale manufacture of modern vaccines. Chapter 89. In: Levine MM et al., eds, New Generation Vaccines. New York: Marcel Dekker Inc., 2004:1081–1091. Table 1 Process of Bulk Manufacture for Selected Vaccine Types Vaccine type Process Examples Attenuated microbial cells Growth and purification of microbial cells adapted or engineered to delete pathogenicity, retaining immunogenicity.
eBook - ePub- Amine Kamen, Laura Cervera(Authors)
- 2022(Publication Date)
- CRC Press(Publisher)
Phase 4 occurs after the vaccine has been approved for use and is incorporated into immunization surveillance programs. This is also known as post-marketing surveillance. This includes ongoing safety monitoring, assessing vaccine effectiveness in specific population groups, and determining the duration of immunity to inform future decisions on the need for booster doses.As it is the case for any biologics, any significant change in the Vaccine Manufacturing process might require clinical demonstrations of safety and eventually efficacy. Manufacturing of vaccines on different sites or countries might require bridging clinical trials. The role of the WHO through “pre-qualification” of Vaccine Manufacturing sites worldwide is an improved process for facilitating commercialization of vaccines in the different regions of the world.1.5 Basic Principles of Viral Vaccine Design and Traditional ProductionThis textbook focuses only on viral vaccines; therefore, although designed using the same principles to activate immune response, other microbial infections and vaccination strategies will not be discussed. Vaccines might be classified taking into consideration their design and mode of exposure of the dominant antigen to the human immune system.Figure 1.1 captures the principles of vaccination and provides a simplified view of the possible interaction pathways with key mediators of the immune response. This section will be detailed in Chapter 3 of this textbook by reviewing the basic principles in immunology that are directly applicable to vaccine design and development.Figure 1.1Description of the different types of vaccines and their possible interaction with the immune system. Credit for the design: Kumar Subramaniam.Traditional viral vaccines involve the whole virus as inactivated or live attenuated, such as influenza vaccines (Chapter 9 ), or a sub-unit, representing the dominant antigen extracted from the viral structure, such as Hepatitis B vaccines. Recombinant DNA technology enabled the design of vectored vaccines (Chapter 11 ) such as adeno-vectored vaccines against Ebola, SARS-CoV-2 infections, virus like-particle vaccines (Chapter 10 ) such as human papilloma virus vaccine, and recombinant protein vaccines such as recombinant hemagglutinin as the first approved influenza vaccine of its kind. An emerging class of vaccines based on delivery of genomic components of the virus include DNA vaccines and mRNA vaccines (Chapter 12 ). Over the COVID-19 pandemic, a remarkable demonstration has been made on safety, efficacy, and effectiveness of mRNA vaccines against SARS-CoV-2 infection, establishing this vaccine technology platform as a major technological jump in vaccinology. As data collected for phase 4 following the vaccine approval and commercialization of COVID-19 mRNA
eBook - PDF- Edward Bauer(Author)
- 2016(Publication Date)
- CRC Press(Publisher)
3 Vaccines and Biologically Produced Pharmaceuticals INTRODUCTION Biotechnology is an exciting area of pharmaceutical research and development. It comprises drugs, proteins, and vaccines. The promise that it holds has captured the imagination and interest of the press and general public. The potential benefit from new products developed by this technology is staggering. It offers the possibility for cures of genetic conditions and for repair and healing of severely damaged cells that cannot repair themselves. It is the brave new world of multidisciplinary science, medicine, and from a packaging perspective, a new range of products to protect. As the technology and the products it manufactures move to commercialization, packaging must develop new methods, materials, and delivery systems. The pharmaceutical industry considers these technologies and the products they manufacture to provide an opportunity to dramatically improve health care on a broad spectrum of problems little understood as few as 10 years ago. Vaccines are in an equally exciting position. The introduction of new vaccines that treat a wide range of diseases, including bacterial meningitis, a severe disease of the brain and spinal canal, is equally as exciting as the biologic drugs. The manufacture of vaccines is undergoing a major change as it shifts from antibody production in eggs to products produced by recombinant RNA and DNA techniques. The research into diseases like HIV has led to the possi-bility of developing a vaccine to immunize against this deadly killer. Our understanding of the immune system in the post-HIV world has improved dra-matically. Targeted vaccine development into areas that permit the body, properly immunized with a vaccine, to fight off many deadly killers is again at the cutting edge of medical technology. 93 How are biologic products made and how are they packaged? The whole idea of biologically produced materials is foreign to the general public.
eBook - PDF- Purusotam Basnet(Author)
- 2012(Publication Date)
- IntechOpen(Publisher)
4 Biological Products: Manufacturing, Handling, Packaging and Storage Nahla S. Barakat King Saud University, College of Pharmacy, Dept. of Pharmaceutics, Saudi Arabia 1. Introduction A biological product is defined as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or any other trivalent organic arsenic compound, applicable to the prevention, treatment or cure of a disease or condition of human beings”. Throughout the 20th century, the world witnessed great discoveries in the biological sciences. One of the earliest biological products introduced to the U.S. marketplace was a blood protein called Factor VIII first sold in 1966. The earliest FDA approval for a modern biotech product designed for human therapeutic use was given to human insulin in 1982, approval was given in 1985 to a human growth hormone (HGH) for the treatment of dwarfism. In the 1990s FDA granted approvals for vaccines against rabies, tetanum toxoids, and pertussis. The manufacturing process for a biological product usually different from the process for drugs. The manufacture of biological medicinal products involves certain specific considerations arising from the nature of the products and the processes. Persons responsible for production and quality control should have an adequate background in relevant scientific disciplines, such as bacteriology, biology, biometry, chemistry, medicine, pharmacy, pharmacology, virology, immunology and veterinary medicine. The degree of environmental control of particulate and microbial contamination of the production premises should be adapted to the product and the production step. Animals are used for the manufacture of a number of biological products, in addition, animals may also be used in the quality control of most sera, antibiotics and vaccines. All biological products should be clearly identified by labels which should be approved by the national control authority.
eBook - ePub- Emily P. Wen, Ronald Ellis, Narahari S. Pujar, Emily P. Wen, Ronald Ellis, Narahari S. Pujar(Authors)
- 2014(Publication Date)
- Wiley(Publisher)
When evaluating manufacturing cost, one must also consider decisions within the context of the global project timeline, as risk and delays can often have a greater impact on the economic viability of a product than the absolute costs themselves. This chapter reviews the interplay between these elements and outlines the techniques often used to evaluate the cost implications of manufacturing decisions. Case studies are also presented to demonstrate these techniques in actual practice.15.2 Vaccine Manufacturing, History, and Drivers
The history of vaccines dates back over 200 years ago to the development of a smallpox vaccine by Edward Jenner in 1798. Developments in vaccination have advanced sufficiently to protect humans and animals from most life-threatening diseases, with large focus applied to these preventative steps during the 1930s, the 1970s, and again today. The invention of antibiotics took the focus away from vaccines during the Second World War, and it was not returned until 1970, when research was revived. The mapping of the human genome coupled with advancements in the understanding of molecular genetics has brought about new interest and techniques for discovery. Today's challenges lie with the prevention of cancer, HIV, and hepatitis. There are two broad types of vaccine used today, each with their own cost structure.15.2.1 Traditional
- Attenuated—the virulent organism is weakened by unnatural host conditions or special modification, with the resultant effect of a scaled down immune response.
- Inactivated—the virus is treated with an agent that destroys its replicative function.
- Hepatitis B plasma derived—the first cancer vaccination was derived from the blood serum of a patient with hepatitis B. The sample was purified and attached to an alum adjuvant, resulting in a safe and effective entity. However, the complex downstream processing and concerns over the safety of human blood serums meant that this solution was only short-lived.
15.2.2 Modern
These vaccines have been developed following developments in molecular genetics and are based on modern processes manufactured in state-of-the-art facilities. They differ from traditional vaccines in that they are highly purified and well characterized.
eBook - ePub- Firdos Alam Khan(Author)
- 2020(Publication Date)
- CRC Press(Publisher)
Viruses are grown either on primary cells such as chicken eggs (e.g., for influenza), or on continuous cell lines such as cultured human cells (e.g., for hepatitis A). Bacteria such as Haemophilus influenzae type b are grown in bioreactors. Alternatively, a recombinant protein derived from the viruses or bacteria can be generated in yeast, bacteria, or cell cultures. After the antigen is generated, it is isolated from the cells used to generate it. A virus may need to be inactivated, possibly with no further purification required. Recombinant proteins (Figure 9.2) need many operations involving ultrafiltration and column chromatography. Finally, the vaccine is formulated by adding adjuvant, stabilizers, and preservatives, as needed. The adjuvant enhances the immune response of the antigen, the stabilizers increase the storage life, and the preservatives allow the use of multidose vials. Combination vaccines are harder to develop and produce because of potential incompatibilities and interactions among the antigens and other ingredients involved. Vaccine production techniques are evolving. Cultured mammalian cells are expected to become increasingly important compared to conventional options such as chicken eggs because of greater productivity and few problems with contamination. Recombination technology that produces genetically detoxified vaccines is expected to grow in popularity to produce bacterial vaccines that use toxoids. Combination vaccines are expected to reduce the quantities of antigens they contain and thereby decrease undesirable interactions by using pathogen-associated molecular patterns. Many vaccines need preservatives to prevent serious adverse effects such as the Staphylococcus infection that, in one 1928 incident, killed 12 of 21 children inoculated with a diphtheria vaccine that lacked a preservative. Several preservatives are available, including thiomersal, phenoxyethanol, and formaldehyde
eBook - PDF- (Author)
- 0(Publication Date)
- The National Academies Press(Publisher)
Manufacturing of vaccines is highly concentrated and competition is very limited. Also, the sole-supplier situation poses a threat to the continued supply of some vaccines. Certain factors adversely affect the commercial attractiveness of Vaccine Manufacturing. As noted in Chapter 3, the potential market for vaccines is comparatively small because repeat sales to recipients are uncommon. The potential market is economically distorted by undervaluation of preventive services—both by the public and by physicians. Vaccines also are undervalued because the total benefits that accrue to society are greater than the sum of benefits to individual recipients (because of reduced transmission). Consequently, research and development costs are relatively large compared to sales revenues. ECONOMIC ASPECTS OF VACCINE INNOVATION AND MANUFACTURING 61 Vaccine Supply and Innovation Copyright National Academy of Sciences. All rights reserved. TABLE 4.11 Vaccine Development and Licensing Product and Manufacturer Application/ Issue Date Comments Anthrax vaccine adsorbed Michigan Dept.
Index pages curate the most relevant extracts from our library of academic textbooks. They’ve been created using an in-house natural language model (NLM), each adding context and meaning to key research topics.
