Immunochemical properties

Habeeb, A.F.S.A., and Atassi, M.Z. (1970) Enzymatic and immunochemical properties of lysozyme. Evaluation of several amino group reversible blocking reagents. Biochemistry 9, 4959—4944. 

Phosphoenolpyruvate carboxykinase (PEPCK) deficiency is distinctly rare and even more devastating clinically than deficiencies of glucose-6-phosphatase or fructose-1,6-bisphosphatase. PEPCK activity is almost equally distributed between a cytosolic form and a mitochondrial form. These two forms have similar molecular weights but differ by their kinetic and immunochemical properties. The cytosolic activity is responsive to fasting and various hormonal stimuli. Hypoglycemia is severe and intractable in the absence of PEPCK [12]. A young child with cytosolic PEPCK deficiency had severe cerebral atrophy, optic atrophy and fatty infiltration of liver and kidney. 

King TP, Kochoumian L and Lichtenstein LM (1977) Preparation and immunochemical properties of methoxypolyethylene glycol-coupled and N-car-boxymethylated derivatives of ragweed pollen allergen, antigen E. Arch Biochem Biophysl78, 442-450. 

Vadeboncoeur, C. Proulx, M. Trahan, L. Purification of proteins similar to HPr and enzyme I from the oral bacterium Streptococcus salivarius. Biochemical and immunochemical properties. Can. J. Microbiol., 29, 1694-1705 (1983)... 

Level II methods are those that are not unequivocal but are used to determine the concentration of an analyte at the level of interest, and to provide some structural information. For example, these methods may employ molecular, functional-group, or immunochemical properties as the basis of the analytical scheme. Hence, these methods are often reliable enough to be used as reference methods. Level II methods commonly separate the determinative from the identification procedures, and may also be used to corroborate the presence of a compound or class of compounds. Tims, a combination of two level II methods may provide attributes suitable for a level I method. The majority of analytical methods presently available and used by regulatory control agencies are level II methods. 

Habeeb, A. F. S. A. and Atassi, M. Z. 1971. Enzymic and immunochemical properties of lysozyme. IV. Demonstration of conformational differences between a-lactal-bumin and lysozyme. Biochim. Biophys. Acta 236, 131-141. 

XII. Preparation of Blood Group Substances from Bovine Stomach Linings and a Comparison of Their Chemical and Immunochemical Properties with Those of Blood Group Substances from Other Species/ J. Immunol. (1952) 68,19. 

The platelet surface contains aggregin, a membrane protein with a molecular weight of 100 kDa, which has physical and immunochemical properties that differ from those of platelet glycoprotein Ilia. 

B. A. Dmitriev and N. K. Kochetkov, Relation of the structure of the specific polysaccharides of the somatic antigens of the bacteria Shigella dysenteriae to immunochemical properties, Dokl. Akad. Nauk SSSR, 245 (1979) 765-768. 

G. Schiffman, E. A. Kabat, and W. Thompson, Immunochemical studies on blood groups. XXXn. Immunochemical properties of and possible partial structures for the blood group A, B, and H antigenic determinants, Biochem. J., 3 (1964) 587-593. 

D. M. Carlson and C. Blackwell, Structures and immunochemical properties of oligosaccharides isolated from pig submaxillary mucins, J. Biol. Chem., 243 (1968) 616-626. 

K. Barnes, J. Ingram, A. J. Kenny, Proteins of the kidney microvillar membrane. Structural and immunochemical properties of rat endopeptidase-2 and its immu-nohistochemical location in tissues of rat and mouse, Biochem J 264 335-346 (1989). 

F5. Foster, M. H., Cizman, B., and Madaio, M. P., Nephritogenic autoantibodies in systemic lupus erythematosus. Immunochemical properties, mechanisms of immune deposition, and genetic origins. Lab. Invest. 69, 494-507 (1993). 

Amongst resistant variants of CEM-7 cells an additional type of receptor defect was detected which has so far not been found in other cell systems [68,69], It was called activation labile because these receptors are very unstable under conditions which normally activate receptor complexes to forms with an exposed DNA binding site. These defective receptors have recently been shown to behave normally in terms of biochemical and immunochemical properties if the hormonal ligand is covalently attached by affinity labelling and therefore is unable to dissociate upon activation [70]. 

The immunochemical properties of the biopharmaceutical should also be fully characterized. This may include binding assays of the antibody to purified antigens, using defined regions of the antigen. Additionally the target antigen,... 

By comparison to the EMEA document, the ICH guideline does not address immunogenicity in the same detail. It does suggest that immunochemical properties be a component of the characterization and considerations for immunogenicity should be a part of the planning of nonclinical and clinical... 

The availability of sensitive analytical tests to adequately characterize a product and to measure the predicted possible changes is central to a comparability assessment. Obviously tests should be chosen that will be the most likely to detect important changes. ICH Q6B offers advice on physicochemical, biological activity, and immunochemical properties, purity (impurity), con-... 

Methionine sulfoxide formation may occur without noticeable changes in physical or immunochemical properties of the protein. Thus reduction of sulfoxide to thioether often completely restores the lost protein function. Many cells, including human polymoprhonuclear neutrophilic leukocytes, contain enzyme methionine sulfoxide reductase, which is able to convert methionine sulfoxide to the reduced methione form in a variety of proteins (B25, F8). Methionine reacting with a strong oxidant effects methionine sulfone production, which in vivo is not reduced back to methionine. 

Methionine oxidation inducing abolition of protein function usually does not produce any changes in chemical and immunochemical properties of the protein. This infers that the oxidized protein can be reactivated again by reduction of sulfoxide residue, or may be catabolized through its regular proteolytic pathway. Facility of methionine oxidation, along with abundant production of various oxidants, enables oxidation of methionine residues. This rises a question concerning... 

Furlong, R. A., Takehara, T., Taylor, W. G., Nakamura, T. and Rubin, J. R. (1991). Comparison of biological and immunochemical properties indicates that scatter factor and hepatocyte growth factor are indistinguishable. J. Cell Sci. 100, 173-177. 

Izzo, J.L. Roncone, A. Izzo, M.J. Bale, W.E. Relationship between degree of iodination of insuhn and its biological electrophoretic and immunochemical properties. J. Biol. Chem. 1964, 239, 3749-3754. 

Hara, A. and H. Hirai. Comparative studies on immunochemical properties of female-specific serum protein and egg yolk proteins in rainbow trout (Salmo gairdneri). Comp. Biochem. Physiol. 59B 339—343, 1978. 

Y3. Yamauchi, T., Koyama, J., and Yamashina, I., Immunochemical properties of ai-acid glycoprotein of human plasma. J. Biochem. (Tokyo) 68, 33-40 (1968). 

These include determination of physicochemical properties, biological activity, immunochemical properties, and purity. The product should be compared with an appropriate reference material or its natural counterpart. 

Also included are analyses of studies reporting distinctive immunochemical properties as well as physical properties of enzymes prepared from several organs. Separate sections are concerned with electrophoretic data and heat sensitivity. 

Characterization of a biotechnological or biological product (which includes the determination of physico-chemical properties, biological activity, immunochemical properties, purity, and impurities) by appropriate techniques is necessary to allow relevant specifications to be established. Acceptance criteria should be established and justified based on data obtained from lots used in preclinical and/or clinical studies, data from lots used for demonstration of manufacturing consistency, data from stability studies, and relevant development data. 

For some DS or DP, the protein molecule may need to be examined using immunochemical procedures [e.g., enzyme-linked immunosorbent assay (ELISA), Westem-blot] and utilizing antibodies that recognize different epitopes of the protein molecule. Immunochemical properties of a protein may serve to establish its identity, homogeneity, or purity, or serve to quantify it. 

If immunochemical properties constitute lot release criteria, all relevant information pertaining to the antibody should be made available. 

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