Purified LH

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

Reexamination Certificate

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Reexamination Certificate

active

07053054

ABSTRACT:
A process for the purification of recombinant human Luteinizing Hormone (LH) from a sample of crude recombinant LH in the supernatant of CHO cells comprises the combined use of the ion-exchange chromatography and reverse phase HPLC. The ion-exchange chromatography and the reverse phase HPLC are performed twice and the final use of a gel permeation column allows the purification from any residual traces of contaminants. The specific bioactivity of the highly purified LH obtained from the process is particularly high, amounting to 25,000 IU/mg.

REFERENCES:
patent: WO 90/02757 (1990-03-01), None
patent: WO 90/09800 (1990-09-01), None
patent: WO 98/20039 (1998-05-01), None
patent: WO 98/58957 (1998-12-01), None
Camero, et al., Aislamiento Y Purification De Hormona Luteinizante Humana, Revista Colombina Dde Quimica, 1993, vol. 22, No. 1, pp. 69-77 and translation.
Rivier, Reversed-Phase high performance Liquid Chromatography: Preparative Purification of Synthetic peptides, journal of Chromatography, 1984, vol. 288, pp. 303-328.
Barnthouse, et al, “Cation-exchange Displacement Chromatography for the Purification of Recombinant Protein Therapeutics from Variants”,J. of Biotechnology, 66: 125-136, XP002138425 (1998).
DYR, et al, “Separation Used for Purification of Recombinant Proteins”,J. of Chromatography B. 699: 383-401 XP-002138424 (1997).
Eder, et al, “New cation-exchange Resins with High Reversed-phased Character fro Solid-phase Extraction of Phenols”,J. of Chromatography A, 810: 43-52 (1998).

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