This paper explains how vaccines are developed and describes in detail their manufacturing process
The Greeks had two gods of health: Aesculapius and Hygieia, therapy and prevention, respectively. Medicine in the twentieth century retains those two concepts, and vaccination is a powerful means of prevention. Vaccines provide the immunity that comes from natural infection without the consequences of natural infection; help protect people from harmful infections before they come in contact with the disease. Vaccines may also help alleviate the symptoms of the infection caused by the virus.Vaccines provide the immunity that comes from natural infection without the consequences of natural infection.
Vaccine development is difficult, complex, highly risky, and costly and includes clinical development, process development and assay development. Vaccine development requires strong management systems and controls, and requisite skill sets among scientists and engineers. Pharmaceutical companies must demonstrate the safety and efficacy of a medicinal product or vaccine through the use of clinical trials, before a regulatory authority registers the product. The vast majority of over one billion doses of vaccines manufactured worldwide each year are given to perfectly healthy individuals. It is this fact that drives the requirements for vaccines to be among the most rigorously designed, monitored and compliant products manufactured today.
Table of Contents
- Vaccines development: Overview and History
- Vaccine development
- The manufacturing process
Objectives and Key Themes
This paper aims to provide a comprehensive overview of vaccine development and manufacturing processes. It explores the history and evolution of vaccines, delving into traditional and modern methods of production. The paper also examines the intricate process of clinical development, encompassing safety, immunogenicity, and efficacy studies.
- History and evolution of vaccine development
- Traditional and modern vaccine production methods
- Clinical development of vaccines
- Safety, immunogenicity, and efficacy of vaccines
- Manufacturing processes and quality control
Chapter Summaries
- Vaccines development: Overview and History: This section traces the historical evolution of vaccines from the early use of live attenuated viruses to the development of modern technologies like recombinant vectors and DNA vaccines. It highlights key milestones and individuals who have significantly impacted vaccine development.
- Vaccine development: This chapter focuses on the complex process of vaccine development, encompassing clinical trials, process development, and assay development. It details the various phases of clinical trials and their importance in establishing the safety and efficacy of vaccines.
- The manufacturing process: This section delves into the intricacies of vaccine manufacturing, outlining the key steps involved in bulk manufacturing and finishing operations. It explores cell culture and fermentation-based manufacturing, separation and purification, and the formulation of vaccines.
Keywords
This paper focuses on key concepts like vaccine development, manufacturing, clinical trials, safety, immunogenicity, efficacy, cell culture, fermentation, purification, formulation, and quality control. It highlights the historical evolution of vaccines, traditional and modern production methods, and the importance of regulatory compliance in ensuring the safety and effectiveness of vaccines.
- Quote paper
- Bruce Wembulua (Author), 2016, Vaccines development and manufacturing process, Munich, GRIN Verlag, https://www.grin.com/document/344660
