Chapters authored
Nanotechnologies Applied in Biomedical Vaccines
Vaccination, one of the most effective strategies to prevent infectious diseases, is the administration of antigenic materials to stimulate an individual’s immune system to develop adaptive immunity to a specific pathogen. Though it is so advantageous for diseases control and prevention, vaccines still have some limitations. Nanotechnology is an approach to prepare a novel biomedicine vaccine with the vaccine consumption and side effects significantly decreased. Regulation is the most important criterion for the development of nanovaccines. All marketing products have to meet the requirement of regulation. The fast-track designation potentially aids in the development and expedites the review of nanovaccines that show promises in an unmet medical need. Here, some successful nanovaccine products are introduced—Inflexal® V, Epaxal®, GardasilTM, and CervarixTM have been widely used for the clinical applications, which are delivered either in the form of virosomes or virus-like particles. Vaccines based on nanotechnology may overcome their original disadvantages and lead to the development of painless, safer, and more effective products.
Part of the book: Micro and Nanotechnologies for Biotechnology
The Regulation Requirement of Dengue Vaccines
Dengue fever (dengue), a mosquito-borne disease caused by dengue viruses (DENVs), represents severe public health problems in Southeast Asia, Latin America, Africa and other subtropical regions. Many regulatory issues arise along with the development of dengue vaccines. It is required to follow the regulatory pathway for the license application. Dengue vaccines can be approved without local clinical phase III data. The national regulatory authorities (NRAs) must have the information, training and ability to review and approve the application. A novel vaccine product Dengvaxia® for dengue has been approved in many countries. The approval is based on clinical trials that show the vaccine could reduce about 60% dengue, prevented 90% of severe cases and 80% of hospitalizations. Several other DNA, live-attenuated, purified inactivated, subunit, vectored and chimeric vaccine candidates are currently developing in clinical phases. Although there are still some challenges for the development and regulation of vaccine, the prospects of dengue vaccines are promising provided that we can overcome the difficulty.
Part of the book: Dengue
Biotechnologies Applied in Biomedical Vaccines
Vaccination, the administration of an antigenic material (vaccine), is considered to be the most effective method for disease prevention and control. A vaccine usually contains an agent that resembles a diseases‐causing pathogen and is often made from inactivated microbes, live attenuated microbes, its toxins, or part of surface antigens (subunit). However, the modern biotechnological tools and genomics have opened a new era to develop novel vaccines and many products are successfully marketing around the world. It is important to formulate and deliver these vaccines appropriately to maximize the potential advances in prevention, therapy, and vaccinology. New vaccines employing biotechnological innovations are helping us to change the way for illness prevention. The clinical application of vaccines will be diversified along with the development of biotechnologies. In modern society, the outbreak of many infectious diseases has decreased through vaccination, but the burden of noninfectious diseases is growing. The new biotechnologies may result in not only the appreciation of vaccines which are critical in inducing protection against an infectious disease but also the production of therapeutic vaccines which are effective for alldiseases including infectious and noninfectious diseases.
Part of the book: Vaccines
Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars
Similar biotherapeutic products (SBPs), also called biosimilars, exhibit similar biological and clinical properties to authorized reference products. Biosimilars, including small molecules like erythropoietin and complex macromolecules like monoclonal antibodies (mAbs), have been used extensively in disease treatment. Monoclonal antibody biosimilars have gradually become a dominant development in the global pharmaceutical industry since their patents or data protection have been expired or nearing expiration. Since the mAb biosimilars are complex biological macromolecules with various post-translation modifications, it is important to evaluate whether these tiny differences significantly affect the quality. From a regulatory perspective, the comparability study needs to be performed to demonstrate that the quality, safety, and efficacy are similar to the biological reference. Based on these comprehensive comparative results, the indicated extrapolation might be acceptable. Post-market surveillance is also required because of unexpected biological variation caused by slightly different manufacturing processes. This chapter presents the scientific and regulatory considerations for monoclonal antibody biosimilar products for manufactures and for the regulatory authorities to administrate wisely and comprehensively.
Part of the book: Biopharmaceuticals