As a primary stability-indicating parameter, potency should be strategically evaluated during each phase of vaccine development. Herein, we present potency testing during the early clinical development of the Schistosoma mansoni (Sm) Tetraspanin-2 vaccine formulated on Alhydrogel (Sm-TSP-2/Al). As Sm-TSP-2/Al does not induce sterilizing immunity against its target pathogen (Sm) in animal models, potency is measured by “serological substitution”, a method that can add significant variation to the potency metric, especially when used in a compliance (or ‘single data point’) approach.Potency data were analyzed using the compliance approach to determine if two clinical lots of Sm-TSP-2/Al retained potency over 84 and 36 months post-release, respectively. These same data were also analyzed by: i) least-squares regression with a joinpoint regression analysis; ii) control charting of stability slopes; and iii) bootstrap modeling. Nested-regression and bootstrapping were used to compare the potency of the first (#11-69F-003) and second (#1975) clinical lots of Sm-TSP-2/Al.Despite significant variability in the immune assay, both clinical lots of Sm-TSP-2/Al remained potent for 84 and 36 months, respectively, in all four statistical approaches. The first lot of Sm-TSP-2/Al showed a gain in potency starting at 36 months post-release as captured by joinpoint regression. The two clinical lots of Sm-TSP-2/Al had comparable long-term potency.While a compliance approach can monitor the long-term stability of Sm-TSP-2/Al, it risks putting this critical stability-indicating parameter out of specification with each time point tested due to statistical multiplicity. Alternative statistical methods, such as joinpoint regression or bootstrapping, do not have this limitation and offer even more precise estimations of potency, with the added benefit of also providing predictive analytics. Nested regression and bootstrapping were shown to be a viable alternatives for lot-to-lot comparisons of the stability of Sm-TSP-2/Al. Instructions for implementing both these potency testing approaches are provided.

The new generic name Calloria is proposed as a replacement for Waltonia Davidson, 1850, the type species of which is the common smooth red endemic terebratulide brachiopod of New Zealand seas. Waltonia was based on a juvenile, imperfect specimen of a ribbed brachiopod belonging to an existing genus, and was abandoned by Davidson in 1861. The complex later nomenclatural history of Waltonia and Magasella Dall is described in detail. A type is selected for Terebratula inconspicua Sowerby, 1846, the type species of Calloria n. gen.

A new species of terebratellid brachiopod, Calloria variegata, is described from rocky, subtidal habitats in the Hauraki Gulf, northern New Zealand. The distribution and ecology of C. variegata are compared with the closely related C. inconspicua, and a detailed description of the new species, including loop development, is provided.

made of the brachiopods from the Jurassic deposits of Saudi Arabia.This first study of the brachiopods from this important

The Tertiary brachiopod fauna of the United States is discussed and reference is made to the composition of the World Tertiary fauna.The brachiopod fauna of the East Coast of the United States at present numbers 17 genera (4 inarticulates and 13 articulates), of which 11 are discussed herein (asterisk): 2 linguilidids: Glottidia* Discradisca; 2 craniidinids: Isocrania?* and Crania?*; 2 rhynchonellids: Probolarina* and Cryptopora, the former extinct; 2 cancellothyrids: Eucalathis* and Terebratulina*

Journal Article Anomalous results on using an inhibitor method for the determination of pancreatic isoenzymes. Get access S Gordon, S Gordon Search for other works by this author on: Oxford Academic Google Scholar G Cooper, G Cooper Search for other works by this author on: Oxford Academic Google Scholar W Murray, W Murray Search for other works by this author on: Oxford Academic Google Scholar R Campbell, R Campbell Search for other works by this author on: Oxford Academic Google Scholar S Oakes S Oakes Search for other works by this author on: Oxford Academic Google Scholar Clinical Chemistry, Volume 30, Issue 2, 1 February 1984, Pages 339–340, https://doi.org/10.1093/clinchem/30.2.339 Published: 01 February 1984

Cooper, G. Arthur New Brachiopods from the Southern Hemisphere and Cryptopora from Oregon (Recent).Smithsonian Contributions to Paleobiology, num¬ ber 41,43 pages, 4 figures, 7 plates, 1982.-TheRecent brachiopods described herein were collected during dredging operations of several research vessels, the United States R/V Eltanin (alias Islas Orcadas while on loan to Argentina) in Antarctica, in the subantarctic waters of the Atlantic around South Georgia and the South Sandwich Islands, and in the Scotia Sea; R/V Hero dredging in Antarctic waters; R/V Anton Bruun operating along the west coast of South America; the initial cruises of R/V Rafale and Thierry operating in the Gulf of Guinea off the coast of West Africa.Seventeen genera are described, including 19 species and 10 lots not identified as to species; Pelagodiscus atlanticus (King), Disamsca laevis (Sowerby), Discimsca species, Cryptopora hespens, new species, the first report of this genus in the northern Pacific, Terebratulina kuensis Dali and Pilsbry, Terebratulina species, Abyssothyns wyvillei (Davidson), A. cf.elongata Cooper, Abyssothyns?species, Liothyrella delsolan, new species, L. expansa, new species, L. fosten, new species, L. georgiana Foster, L. hendlen, new species, L. notorcadensis (Jackson), L.? vema Cooper, Platidia species, Argyrotheca species, Megathms species, Pantellana monstruosa (Scacchi), Macandrevia amencana Dali, Macandrevia species, Notorygmia species, Terebratella?species, Syntomana curiosa, new genus and species, Dyscntosia secreta, new genus and species, Neothyns parva, new species.The loop development of the new genera is described and illustrated in detail.Most of the localities from which the specimens were taken add geographic and bathymetric information new for these genera.

Specimens collected from 120 stations around and between the subantarctic islands: Marion, Prince Edward

Cooper, G. Arthur.Brachiopoda from the Gulf of Gascogne, France (Recent).Smithsonian Contributions to Paleobiology, number 44, 35 pages, 5 figures, 3 plates, 1981.-Brachiopodscollected during the operations of Biogas and Polygas, Gulf of Gascogne Abyssal Survey, and Thalassa, Gulf of Gascogne Bathyal Survey of the Centre Oceanologique de Bretagne, are recorded and data concerning them noted.Most of the specimens taken in Biogas and Polygas are from depths ranging from 1010 meters to 4459 meters.The specimens taken by Thalassa are mostly from waters less than 1000 meters in depth.Twenty-one species in 14 genera are recognized, six of them, including a new species, hitherto not recorded from the Gulf of Gascogne, are starred: *Pelagodiscus atlanticus (King), Crania anomala (Muller), C. anomala turbinata (Poli), *Cryptopora gnomon Jeffreys, Hispamrhynchia cornea (Fischer), Eucalathis ergastica Fischer and Oehlert, E. tuberata (Jeffreys), Terebratulina retusa (Linne), T. retusa emarginata (Risso), Gryphus vitreus (Born), *G.P coopen d Hondt, Dallithyns? aff.DP sphenoidea (Jeffreys), Platidia anomioides (Scacchi and Philippi), Megerha truncata (Linne), M. echinata (Fischer and Oehlert), Pantellana monstruosa (Scac¬ chi), Macandrevia cranium (Muller), *M.novangliae Dali, *Fallax dalliniformis Atkins, Dallina septigera (Loven), and *D.parva, new species.Five described species not previously recorded from the Gulf of Gascogne are: Pelagodiscus atlanticus (King), a world-wide abyssal form; Cryptopora gnomon (Jeffreys), widespread in the northern Atlantic; Macandrevia novangliae Dali, hitherto only known from deep water off the coast of New England, United States; Fallax dalliniformis Atkins, newly discovered in the approaches to the English Channel; and Gryphus?coopen d'Hondt recently described.The first four were taken in deep water in the Biogas operations; the fifth was taken by Thalassa.Speci¬ mens taken by Thalassa are mostly small or immature forms that are usually difficult to identify generically.Specimens of the rare genus Eucalathis ap¬ peared in several lots taken by Thalassa as well as the new species, Dallina parva.Not included in the above lists is a fossil brachiopod, dredged by Thalassa, that is assigned with a query to the Cretaceous genus Meoma.

Cooper, G. Arthur.Tertiary and Cretaceous Brachiopods from Cuba and the Caribbean.Smithsonian Contributions to Paleobiology, number 37, 45 pages, 2 figures, 7 plates, 1 table, 1979.-Thirty-ninetaxa of fossil brachiopods are de¬ scribed, figured, and discussed.Three come from Cretaceous rocks of Cuba and the remainder were found in Tertiary sediments of Cuba and other parts of the Caribbean region.These range in age from Eocene to Pliocene.Fourteen genera are identified of which two are new: one from the Cretaceous and the other from the Eocene, both from Cuba.Thirty species are recognized among the fossil genera: Cruralina, 1 (new); Terebratulina, 1 (new); Tichosina, 2 new; Tichosina?, 3 (1 new); Stenosarina, 1 (new); Gryphus, 4 (2 new); Gryphusf, 1; Dyscritothyris, 1 (new genus and species); Argyrotheca, 12 (11 new); Cistellarcula, 1 (new); Hercothyris, 2 (new genus and 2 new species); Lacazella, 1. Representatives of the following genera are not iden¬ tified specifically: Cryptopora, Rugia, Terebratulina, Platidia, Argyrotheca, Thecidellina.

Cooper, G. Arthur. Tertiary and Quaternary Brachiopods from the Southwest Pacific. Smithsonian Contributions to Paleobiology, number 38, 23 pages, 4 figures, 2 plates, 1978.—Brachiopods from Tertiary and Quaternary sediments in the islands of the South Pacific are rarities. They are important in helping us to understand the geographic and geologic distribution and evolution of parts of the phylum. This paper describes genera and species from Fiji, Java, and the New Hebrides. All except two of the genera live in the South Pacific today but are rare, absent, or not yet taken from the waters surrounding Fiji and the New Hebrides: Craniscus?, Cryptopora, Basiliola, Terebratulina, Abyssothyris, Dallithyris?, Argyrotheca, Platidia, Frenulina, Dallina, and Thecidellina. The exceptions are: an extinct new genus, here named Dicrosia, and Lacazella, a genus common in the Mediterranean, less common in the Caribbean, but not now known to be living in the Pacific. OFFICIAL PUBLICATION DATE is handstamped in a limited number of initial copies and is recorded in the Institution's annual report, SMITHSONIAN YEAR. SERIES COVER DESIGN: The trilobite Phacops rana Green. Library of Congress Cataloging in Publication Data Cooper, Gustav Arthur, 1902Tertiary and Quaternary brachiopods from the Southwest Pacific. (Smithsonian contributions to paleobiology ; no. 38) liibliography: p. 1. Brachiopoda, Fossil. 2. Paleontology—Cenozoic. 3. Paleontology—Oceania. I. Title., II. Series: Smithsonian Institution. Smithsonian contributions to paleobiology ; no. 38. QE701.S56 no. 38 [QB796] 5601'.8s [564'.8] 78-606152

TWO new species and two previously described species of brachiopods were dredged off the west coast of Africa by the R/V John Elliott Pillsbury of Miami Uni- versity, Florida, and the R/V Atlantis of Woods Hole Oceanographic Institution. Three species were taken by the Pillsbury from the Gulf of Guinea: Pelagodiscus atlanticus (W. King), Kraussina mercatori Helmcke and a large new species of Macandrevia. Another species of Macandrevia in addition to Pelagodiscus was taken by the Atlantis off the coast of Angola. All except the Kraussina are from deep water. Although the two species of Macandrevia from off Africa are similar, that from Angola, M. africana, differs from the species from the Gulf of Guinea, M. bayeri, in having the anterior commissure sulcate in about 90% of the specimens. This species is thus tending toward the sulcate macandreviid genus Notorygmia living in the Pacific today. This seems to be an example of collateral evolution described recently by Shaw. A few examples comparable to the evolution exhibited by African Macandrevia are given from several parts of the geological column.

s Brachiopods (Recent).Smithsonian Contributions to