A. Levieux et al., Immunochemical control of the species origin of porcine crude heparin and detection of ovine and caprine materials, J PHARM B, 27(1-2), 2002, pp. 305-313
As a consequence of the outbreak of bovine spongiform encephalopathy (BSE),
ruminants materials have been generally banned from the production of hepa
rin. Immunochemical methods have been recently developed for the control of
the raw materials used by manufacturers of materials such as porcine mucos
a and for the detection of bovine crude heparins. To certify the porcine or
igin of crude porcine heparins and to exclude ovine or caprine materials, n
ew ELISAs were developed. Rabbit antisera were produced against species-spe
cific antigenic contaminants present in crude heparins or in eluted materia
ls (EM) from the chromatographic step of the purification process. When ana
lysed by line immunoelectrophoresis, these antisera revealed five to eleven
antigenic contaminants in the EMs, the major one being the most anodic and
predominant antigen in crude heparins. Using the best antisera, competitiv
e indirect ELISAs were optimised. They allowed the detection of porcine, ov
ine and caprine crude heparins down to a dilution of 0.6 to 1.5 parts per 1
000, with CVs ranging from 3 to 12%. These ELISAs complete the set of immun
ological techniques which can be routinely used by heparin manufacturers to
secure their supply chain. (C) 2002 Elsevier Science B.V. All rights reser
ved.