The Regulatory Evaluation of Vaccines for Human Use

Abstract

A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to prevent, ameliorate, or treat a disease or infection. A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), mRNA, living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive testing and characterization. Special expertise and procedures are required for the manufacture, control, and regulation of vaccines. Throughout their life cycle from preclinical evaluation to post-licensure lot release testing, vaccines are subject to rigorous testing and oversight by manufacturers and national regulatory authorities. In this chapter, an overview of the regulatory evaluation and testing requirements for vaccines is presented.

Development and Qualification of an Antigen Integrity Assay for a Plasmodium falciparum Malaria Transmission Blocking Vaccine Candidate, Pfs230

“…Furthermore, lot-to-lot consistency and stability of drug substance or drug product must be assessed. Multiple biophysical and biochemical methods, such as western blot, high-performance liquid chromatography (HPLC), circular dichroism, static light scattering, and dynamic light scattering, are commonly used for the quality control of vaccines, but a potency assay is another key evaluation [ 5 , 6 ]. In the case of a malaria TBV, based on the mode of action, an in vivo immunization study (often in mice) that assesses antisera or induced antibodies by SMFA is an acceptable potency assay.…”