Method for determining the biological activity of recombinant hu

Details Method for determining the biological activity of recombinant hu Method for determining the biological activity of recombinant hu

1996-04-19

1998-03-31

Ulm, John

Chemistry: natural resins or derivatives; peptides or proteins;

Proteins, i.e., more than 100 amino acid residues

Separation or purification

530399, 530417, 530422, C07K 114, C07K 120, C07K 1461

Patent

active

057340242

ABSTRACT:
A method is provided for determination of the biological activity, purity and/or homogeneity of recombinant human growth hormone ("rhGH") using an analytical chemistry test. The method is based on distribution of the rhGH between two or more immiscible aqueous phases and the subsequent determination of the ratio of rhGH concentration in the phases. The ratio is then used as a relative measure of biological activity, homogeneity, and purity, when calibrated against a sample of rhGH that was previously characterized with respect to its activity, homogeneity and purity. Typical applications of this test include quality control, quality assurance, biological identity testing, etc.

REFERENCES:
patent: 5407810 (1995-04-01), Builder et al.
Zaslavsky et al. Biochim. Biophys. Acta 579:463-465, 1979.
Wingun et al. J. Chromatog. B. 680:113-122, 1996.
Johansson, G. in Walter et al. (Ed) Partitioning in Aqueous Two-Phase Systems. Acad. Press, Orlando, FL. 161-226, 1985.
Zaslavsky, B.Y. Aqueous Two-Phase Partitioning. Marcel Dekker, Inc., New York. pp. 401-446, 1995.

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