Bovine origins

Where affected excipients are used—particularly when of bovine origin—including lactose, gelatin, stearic acid/stearates, etc., a statement of compliance with the current requirements relating to transmissible spongiform encephalopathies is included in the EPARs. 

Anderson PM, Schultze MO. Cleavage of S-(l,2-dichlorovinyl)-L-cysteine by an enzyme of bovine origin. Arch Biochem Biophys 1965 lll(3) 593-602. 

Endothelial cells can also be prepared from tissue from other species. Capillary endothelial cells of bovine origin are used quite frequently, because these cells are rather sensitive to treatment with angiogenesis inhibitors such as angiostatin and endostatin (Griffioen et al., unpublished results). It should be noted however, that species-dependent responses to drugs can occur. 

Thrombin, topical (bovine origin) [FDA former as originally approved]... 

Heparin-induced thrombocytopenia (HIT) is a systemic hypercoagulable state that occurs in 1-4% of individuals treated with UFH for a minimum of 7 days. Surgical patients are at greatest risk. The reported incidence of HIT is lower in pediatric populations outside the critical care setting and is relatively rare in pregnant women. The risk of HIT may be higher in individuals treated with UFH of bovine origin compared with porcine heparin and is lower in those treated exclusively with LMWH. 

Commercially albumins are obtained from avian eggs, fractionated blood products of human or bovine origin, or from plant sources such as soy bean. 

Harrison, L. J. S., Le Riche, P. D. Sewell, M. M. H. (1986). Variations in Echinococcus granulosus of bovine origin identified by enzyme electrophoresis. Tropical Animal Health and Production, 18 48-50. 

Enzyme replacement therapy (ERT) is a therapeutic approach in which the specific enzyme that is absent or inactive in affected individuals is replaced with a functional enzyme molecule. Pancreatic enzyme preparations of porcine or bovine origin have been available in the United States for treatment of exocrine pancreatic insufficiency (EPI) in children and adults with cystic fibrosis and chronic pancreatitis since before the enactment of the Federal Food, Drug and Cosmetic Act of 1938 (ref FDA guidance on EIP April 2004). A... 

Figure S. A diagrammatic illustration of the manufacturing processes fm LMWHs. Uniractionated hqrarin of pOTcine or bovine origin is depolymerized by chemical or enzymatic digestion in controlled ccmditimis. The degree of depolymerization is adjusted to obtain LMWH of varying weight...

Oxygen carriers can be divided into two classes hemoglobin-based oxygen carriers, prepared from hemoglobin of human or bovine origin, and synthetic perfluorocarbons. 

Insulin is an early and classic example of a biotechnology product. It illustrates some of the general problems that are associated with peptide drugs and how modem technology leads to improved therapy. Prior to the production of human insulin by cell-based fermentation processes, treatment was with pancreatic extracts of porcine or bovine origin. Many patients developed insulin resistance, and... 

S. aureus strains of bovine origin have been found to produce a surface protein known as biofilm associated protein (Bap) which supports biofdm formation... 

Replacement of heart valves was introduced into clinical practice around 1960. In the past few years, heart valves have been among the most apphed cardiovascular prostheses, which have had a dramatic effect on patients suffering from valvular diseases [120,121], Currently, clinically accepted heart valves include mechanical valves and bioprosthetic valves of porcine or bovine origins. Mechanical valves... 

Various investigators (Halpern et al. 1967 Federlin et al. 1969 Federlin 1971 Feinglos and Jegasothy 1969 Faulk et al. 1975 MacCuish et al. 1975 Diem and Teuscher 1979 Diem et al. 1982) have shown that insulin of porcine or bovine origin can induce lymphocyte transformation in lymphocytes from diabetic patients with both immediate- or delayed-type hypersensitivity to commercial insulin. Such cell-mediated reactions to insulin in vitro have also been reported in untreated diabetics they are rather common in insulin-treated diabetics even without any evidence of allergy in vivo (MacCuish et al. 1975). 

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