Epitopes Of Tilapia Red Blood Cells. I. Species-Specific Antibodies For The Control Of Tilapia Breeding Stocks

Specific antisera against red blood cells of some tilapia species were obtained by reciprocal inter- specific and intergeneric immunizations. The antisera were used to confirm co-dominant expres- sion of epitopes in F1 interspecific hybrids and to identify the parental origin of three red tilapia strains. The antisera in all hybrids (Oreochromis niloticus x O. mossambicus, O. aureus x O. horno- rum, O. niloticus x S. galilaeus and O. niloticus x O. aureus) were positive to both parental strains. However, while all F1 hybrids of O. mossambicus x O. hornorum were positive to anti-O. mossambi- cus antiserum, only 50% were positive to anti-O. hornorum antiserum. In most cases, these results point to co-dominant expression of the species-specific epitopes in hybrids. In addition, the triple parental origins of the Philippine red tilapia (positive for O. aureus, O. mossambicus and O. niloticus epitopes) and of mossambicus red tilapia (positive for O. hornorum, O. mossambicus and O. niloticus epitopes) were assessed. The O. niloticus red tilapia, described as a purebred red variant of O. niloticus, was positive for both anti-O. niloticus and anti-O. aureus antibodies, with a significantly more intense reaction to the latter. A possible genetic basis of this last finding is discussed

Physicochemical and Biological Examination of Two Glatiramer Acetate Products

Herein we compared 40 mg/mL lots of the active ingredient, glatiramer acetate, manufactured by Mylan/Natco to the active ingredient, glatiramer acetate in Copaxone (Teva Pharmaceuticals, Ltd., Netanya Israel) using physicochemical (PCC) methods and biological assays. No differences were seen between the Mylan/Natco and Teva lots with some low resolution release PCC assays (amino acid analysis, molecular weight distribution, interaction with Coomassie Brilliant Blue G-250). Changes in polydispersity between Mylan/Natco and Copaxone lots were found using size exclusion chromatography and the high resolution PCC method, known as Viscotek, and suggestive of a disparity in the homogeneity of mixture, with a shift towards high molecular weight polypeptides. Using RPLC-2D MALLS, 5 out of 8 Mylan/Natco lots fell outside the Copaxone range, containing a high molecular weight and high hydrophobicity subpopulation of polypeptides not found in Copaxone lots. Cation exchange chromatography showed differences in the surface charge distribution between the Copaxone and Mylan/Natco lots. The Mylan/Natco lots were found to be within Copaxone specifications for the EAE model, monoclonal and polyclonal binding assays and the in vitro cytotoxicity assay, however higher IL-2 secretion was shown for three Mylan/Natco lots in a potency assay. These observations provide data to inform the ongoing scientific discussion about the comparability of glatiramer acetate in Copaxone and follow-on products