The consistency approach for the quality control of vaccines

Abstract

Current lot release testing of conventional vaccines emphasizes quality control of the final product and is characterized by its extensive use of laboratory animals. This report, which is based on the outcome of an ECVAM (European Centre for Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy) workshop, discusses the concept of consistency testing as an alternative approach for lot release testing. The consistency approach for the routine release of vaccines is based upon the principle that the quality of vaccines is a consequence of a quality system and of consistent production of lots with similar characteristics to those lots that have been shown to be safe and effective in humans or the target species.The report indicates why and under which circumstances this approach can be applied, the role of the different stakeholders, and the need for international harmonization. It also gives recommendations for its implementation.

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.…”

Potency Evaluation of Recombinant Human Erythropoietin in Brazil: Assessment of Reproducibility Using a Practical Approach

“…Another approach, which was also used in the present study, concerns the assessment of the applicability of control charts as an additional tool for quality control and assesses the consistency of biological assays results. Control charts for individual values are statistical tools used to assess the central tendency of a process over time and to support preventive and/or corrective actions when necessary (Hendriksen et al 2008). The control charts (Fig.…”

“…Monitoring can be accomplished using control charts (Hendriksen et al 2008), and its application to the quality control of vaccines was described 60 years ago by Batson and colleagues (Batson et al 1951). Trend analysis of the results obtained by INCQS, including the behavior of the reference standard, as well as comparisons between their results and those obtained by the producer, should be performed (Hendriksen et al 2008;WHO 2010). Using SPC Explorer RT ™ (Quality America Inc.; EUA), the control charts were plotted for both INCQS and the manufacturer results of the 47 samples tested.…”

“…Using SPC Explorer RT ™ (Quality America Inc.; EUA), the control charts were plotted for both INCQS and the manufacturer results of the 47 samples tested. The warning (±2 SD), control limits (±3 SD) and mean using the first 20 results was calculated (Bastson et al 1951;Hendriksen et al 2008;Pyzdek 2008;WHO 2013).…”