Control of ph transitions during chromatography

Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Separation or purification

Reexamination Certificate

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C530S350000, C514S002600, C435S069100

Reexamination Certificate

active

07101982

ABSTRACT:
The invention provides methods of controlling pH variations during chromatography. In particular embodiments, the invention includes equilibrating and eluting proteins from chromatography resins have a solid phase that possesses a charged functional group on its backbone under controlled conditions of osmolarity and pH. The invention is particularly useful in the purification of proteins that are sensitive to pH transitions such as, for example, the IL-1 Receptor type II protein.

REFERENCES:
patent: 5767064 (1998-06-01), Sims et al.
patent: 6162629 (2000-12-01), Baker et al.
patent: WO 90/12803 (1990-11-01), None
Clayton and Bushuk, “Ion Exchange Chromatography of Proteins Artifact Separations Resulting From Inadequate pH Control,”J Chromatog21:67-74, 1966.
Frey et al., “Numerical Studies of Multicomponent Chromatography Using pH Gradients,”AlChE Journal41(5):171-1183, 1995.
Fuchs et al., “Determination of Optimal Non-Denaturing Elution Conditions From Affinity Columns by a Solid-Phase Screen,”BioTechniques31(3):584-596, 2001.
Ghose, “Practical Aspects of Large-Scale Chromatography of Biologicals -Short Course,”International Business Communications,Nov. 15, 2000.
Jansen et al., “Effect of pH and Concentration on Column Dynamics of Weak Electrolyte Ion Exchange,”AlChE Journal42(7):1925-1937, 1996.

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