Quality-control issues and approaches in vaccine development

Abstract

The successful development of vaccines is a lengthy process, requiring input from different expertises, such as research and development, quality control, quality assurance, production, regulatory affairs, and marketing and sales. A cornerstone in vaccine development is the availability of a panel of high-quality assays that can reduce the risk of failure in clinical trials and licensure. This review highlights the quality-control issues and approaches in vaccine development from different viewpoints: discovery, process development, assay development, clinical development and the postlicensing phase.

Immunoagglutination Test Using Monoclonal Antibodies Coupled to Latex Particles to Identify The Streptococcus Pneumoniae Capsular Polysaccharides Serotype 1, 5, 6B, 14 And 19F In Quimi-Vio Vaccine

“…Generally they are qualitative rather than quantitative methods. [8,17,18] In the case of the Cuban vaccine against Spn"Quimi-Vio", the identity test aims to identify (qualitatively) in the context of multivalent formulation the seven PsCs present in it. In this work we present the Immunoalgutination assay as a method to carry out the identity test of this vaccine, using the MAbs against five of the PsC present in the vaccine (1, 5, 6B, 14, and 19F), coupled to latex particles.…”

“…[8,18,22]Among the first are: nuclear magnetic resonance (NMR), reverse phase chromatography, twodimensional electrophoresis (isoelectric focusing followed by SDS-PAGE) and mass spectrometry, etc. Is true that many of these methods have revolutionized identity testing from the technological point of view, they have the disadvantages of being very expensive, not being available to all laboratories, they need a highly qualified staff and in most of the cases require prior treatment of the sample.…”

“…Is true that many of these methods have revolutionized identity testing from the technological point of view, they have the disadvantages of being very expensive, not being available to all laboratories, they need a highly qualified staff and in most of the cases require prior treatment of the sample. [8,9,10] Immunoassays are based on the Antigen-Antibody reaction. In immunoagglutination techniques, this Ag-Ac reaction becomes visible (agglutination) because one of the two molecules are forming part of or artificially joined to particulate systems such as the surface of red blood cells, platelets, leukocytes, or latex particles, etc.…”

“…These controls include (among many others) the identification of active ingredients present in vaccines as a mandatory requirement for final product release. [7,8] Several techniques have been used for vaccine identity test, among which are the immunoassays, that are simple techniques, easy to carry, to interpret the results, and accessible to all. Immunoagglutination technique specifically using latex reagents is within immunoassays and have been very useful because they are the fastest and can be carried out anywhere without the need of can technology complexity.…”

New tools for NTD vaccines: A case study of quality control assays for product development of the human hookworm vaccineNa-APR-1M74

“…Often, these assays become important components in the licensure of the vaccine. 35 In this study, we have presented (1) a fluorescence polarization assay to monitor the lot to lot production of the human hookworm vaccine candidate Na-APR-1 M74 and (2) an antibody inhibition assay to assess the functional capacity of anti-Na-APR-1 M74 IgG induced by vaccination. Together, these assays comprise a "toolbox" for monitoring the Na-APR-1 M74 vaccine antigen, which will undoubtedly aid in the development of a human vaccine to fight this debilitating NTD.…”