The composition and dental properties of eight different soft drinks, representing some of the most popular types used in the UK, were examined. Demineralization experiments were conducted on hydroxylapatite, the basic component of dental enamel, determining calcium dissolving by atomic absorption spectroscopy and phosphorus by u.v. visual spectrophotometry. The titratable acid content of the drinks was found to give a better guide than their pH to their potential dental erosiveness. The sugar content, in their ready-to-drink form, varied from zero in a low-calorie product up to almost 14 % in a blackcurrant drink, but using a technique with a relatively long contact time, and in the absence of intact dental plaque, the demineralizing action on hydroxylapatite of the acids already in the drinks eclipsed the effects of the acid generated by oral micro-organisms from the sugars in the drinks. The pure citrus juices showed potentially the worst dental properties, followed by the orange and blackcurrant concentrates after dilution to their ready-to-drink form, with least demineralization from the carbonated drinks, and a cola drink giving especially low values.

Eighteen different infants' drinks from five manufacturers were examined for their carbohydrate, calcium, phosphorus and acid contents, and their attack on tooth mineral. Seven of the drinks were compared with nine varieties of adults' soft drinks, and demineralization was studied with and without the presence of a cariogenic oral streptococcus. The influence of the acids already in the drinks in dissolving Ca and P outstripped that of any acid generated in these studies in vitro by microbial fermentation of the sugars they contained, giving an indication of their relative erosiveness rather than their cariogenic action. Various other features of the drinks relevant to dental health were identified. Titratable acid was a better guide than pH to their dental properties. Although there were considerable differences between the various infants' drinks, taken as a group, their acidity levels and demineralizing powers were generally lower than those of the adults' drinks.

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Towards achieving the goal of eliminating epidemic outbreaks of meningococcal disease in the African meningitis belt, a pentavalent glycoconjugate vaccine (NmCV-5) has been developed to protect against Neisseria meningitidis serogroups A, C, Y, W and X. MenA and X polysaccharides are conjugated to tetanus toxoid (TT) while MenC, Y and W polysaccharides are conjugated to recombinant cross reactive material 197 (rCRM197), a non-toxic genetic variant of diphtheria toxin. This study describes quality control testing performed by the manufacturer, Serum Institute of India Private Limited (SIIPL), and the independent control laboratory of the U.K. (NIBSC) on seven clinical lots of the vaccine to ensure its potency, purity, safety and consistency of its manufacturing. In addition to monitoring upstream-manufactured components, samples of drug substance, final drug product and stability samples were evaluated. This paper focuses on the comparison of the vaccine’s critical quality attributes and reviews key indicators of its stability and immunogenicity. Comparable results were obtained by the two laboratories demonstrating sufficient levels of polysaccharide O-acetylation, consistency in size of the bulk conjugate molecules, integrity of the conjugated saccharides in the drug substance and drug product, and acceptable endotoxin content in the final drug product. The freeze-dried vaccine in 5-dose vials was stable based on molecular sizing and free saccharide assays. Lot-to-lot manufacturing consistency was also demonstrated in preclinical studies for polysaccharide-specific IgG and complement-dependent serum bactericidal activity for each serogroup. This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India.