The need to monitor, measure, and control sub-visible proteinaceous particulates in biopharmaceutical formulations has been emphasized in recent publications and commentaries. Some of these particulates can be highly transparent, fragile, and unstable. In addition, for much of the size range of concern, no practical measurement method with adequate sensitivity and repeatability has been available. A complication in measuring protein particulates in many formulations is the simultaneous presence of other particle types such as silicone micro-droplets, air bubbles, and extrinsic contaminants. The need has therefore been identified for new analytical methods which can accurately measure and characterize sub-visible particulates in formulations. Micro-flow imaging has been shown to provide high sensitivity in detecting and imaging transparent protein particles and a unique capability to independently analyze such populations even when other particle types are present.

The common pathogenic prodiplostomulum metacercaria in the flesh, mostly near the skin, of pond-produced channel catfish Ictalurus punctatus has been demonstrated to be Bolbophorus damnificus Overstreet & Curran n. sp. The catfish acquires the infection from the snail Planorbella trivolvis, the only known first intermediate host, and the species is perpetuated through the American white pelican Pelecanus erythrorhynchos, as confirmed by experimental infections with nestling and dewormed adult pelican specimens in conjunction with molecular data. It differs from the cryptic species Bolbophorus sp., also found concurrently in the American white pelican, by having eggs 123-129 microm rather than 100-112 microm long and consistent low values for nucleotide percentage sequence similarity comparing COI, ITS 1/2, 18S rRNA and 28S rRNA fragments. Bolbophorus sp. is comparable but most likely distinct from B. confusus (Kraus, 1914), which occurs in Europe and has eggs 90-102 microm long. Its intermediate hosts were not demonstrated. The adults of neither of the confirmed North American species of Bolbophorus were encountered in any bird other than a pelican, although several shore birds feed on infected catfish, and B. damnificus can survive but not mature when protected in the mouse abdominal cavity. B. ictaluri (Haderlie, 1953) Overstreet & Curran n. comb., a species different from B. damnificus, is considered a species inquirenda.

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