Development, preparation, and testing of VAQTA®, a highly purified hepatitis A vaccine

Manufacture of VAQTA^®, an inactivated hepatitis A vaccine, uses state-of-the-art technologies in cell culture and bioprocessing science, which have made it possible to routinely produce the vaccine at manufacturing scale. VAQTA^® consists of an attenuated strain of hepatitis A virus that is highly purified and formaldehyde-inactivated, then formulated with an aluminum hydroxide adjuvant. Process development and scale-up have resulted in a well-characterized vaccine manufacturing process with appropriate in-process controls to assure consistent performance, and a reproducible, well-defined product. Results are presented from a series of manufacturing demonstration lots to show consistency, as well as comparability to clinical lots prepared at an earlier stage in development.     

Metaphycus anneckei and Metaphycushageni: two discrete speciesparasitic on black scale, Saissetia oleae

Parasitized black scale, Saissetia oleae, were collected from olives(Olea europaea L.) in Spain and from thismaterial an encyrtid parasitoid was reared that istaxonomically similar to Metaphycus anneckeiGuerrieri and Noyes. Differences were noted betweenthe Spanish Metaphycus nr. sp. anneckeiand material described as M. anneckei that isresident to California. Although dissimilar in fewmorphological characters, the ovipositor length andshape of the male genitalia and the antennal club ofboth sexes can be used to discriminate between M.anneckei resident to California and the Spanishmaterial, which was subsequently named Metaphycushageni Daane and Caltagirone. To determine ifmorphological differences correspond to biologicaldifferences, reproductive and oviposition behavioursof Californian M. anneckei and SpanishM. hageni were studied. Mating was not observedbetween individuals of the two types and only maleprogeny were produced in interspecific pairings. Metaphycus anneckei females deposit eggs through thescale's ventral side and were never observed to hostfeed, while M. hageni females oviposit throughthe scale's dorsum and frequently host fed. Thecollective biological evidence agrees withmorphological evidence, indicating that M.anneckei and M. hageni are discrete species. Specimens from recent collections in California andSpain were compared with specimens from earliercollections (1910s to 1980s) in Australia, California,Greece, Hawaii, Italy, Israel, Mexico, and SouthAfrica. With the exception of Greek and Spanishmaterial, all specimens examined were M.anneckei. We discuss the significance of this newinformation with respect to biological control andprovide a key to separate these and other closelyrelated black scale parasitoids.     

Synergism between morphogenetic mutants of Myxococcus xanthus.

Myxococcus xanthus, a social procaryotic microorganism, forms fruiting bodies and myxospores. We have isolated a collection of mutants of M. xanthus that are defective in fruiting morphogenesis and have studied synergistic interaction in pairwise mixtures of these mutants. Certain pairs of these fruiting-defective mutants can fruit when mixed together. Similarly, certain mutants that cannot sporulate under standard fruiting conditions can form myxospores in the presence of wildtype or other nonsporulating mutants. The pattern of synergism between pairs of conditional nonsporulating mutants defines at least three and probably four groups of mutants, such that members of a group cannot synergize with each other but can synergize with members of other groups.     

A New Approach to Standardize Multicenter Studies: Mobile Lab Technology for the German Environmental Specimen Bank

Technical progress has simplified tasks in lab diagnosis and improved quality of test results. Errors occurring during the pre-analytical phase have more negative impact on the quality of test results than errors encountered during the total analytical process. Different infrastructures of sampling sites can highly influence the quality of samples and therewith of analytical results. Annually the German Environmental Specimen Bank (ESB) collects, characterizes, and stores blood, plasma, and urine samples of 120–150 volunteers each on four different sampling sites in Germany. Overarching goal is to investigate the exposure to environmental pollutants of non-occupational exposed young adults combining human biomonitoring with questionnaire data. We investigated the requirements of the study and the possibility to realize a highly standardized sampling procedure on a mobile platform in order to increase the required quality of the pre-analytical phase. The results lead to the development of a mobile epidemiologic laboratory (epiLab) in the project “Labor der Zukunft” (future’s lab technology). This laboratory includes a 14.7 m² reception area to record medical history and exposure-relevant behavior, a 21.1 m² examination room to record dental fillings and for blood withdrawal, a 15.5 m² biological safety level 2 laboratory to process and analyze samples on site including a 2.8 m² personnel lock and a 3.6 m² cryofacility to immediately freeze samples. Frozen samples can be transferred to their final destination within the vehicle without breaking the cold chain. To our knowledge, we herewith describe for the first time the implementation of a biological safety laboratory (BSL) 2 lab and an epidemiologic unit on a single mobile platform. Since 2013 we have been collecting up to 15.000 individual human samples annually under highly standardized conditions using the mobile laboratory. Characterized and free of alterations they are kept ready for retrospective analyses in their final archive, the German ESB.