Merck Sharp + Dohme Corp.

Allison D Ortigosa

Mark C Sleevi

Michael Patrick Coleman

Michael A Rauscher

Kartoa Chow

Shibu T George

William L Perry

Douglas S Watson

Rebecca A Chmielowski

Kathryn M Story

Luis Sierra

William Perry

A process is described for purifying insulin and insulin analogs that comprises high-pressure liquid chromatography with an acidic cation exchange medium performed in the presence of a water miscible organic modifier and at an elevated temperature followed by reverse phase chromatography performed in the presence of a water miscible organic modifier and at an elevated temperature.

Purifying insulin using cation exchange and reverse phase chromatography in the presence of an organic modifier and elevated temperature

A process for solubilization and refolding of precursor insulin or insulin analogs from inclusion body isolates for use in the production of insulin or insulin analog is described.

Process for obtaining insulin with correctly formed disulfide bonds

A process is described for purifying insulin and insulin analogs that comprises high-pressure liquid chromatography with an acidic cation exchange medium performed under low to moderate pressure at an elevated temperature.

Process for purifying insulin and analogues thereof

A process is described for purifying insulin and insulin analogs that comprises use of two or more orthogonal chromatographic purification steps in tandem following enzymatic digestion of the propeptide-insulin precursor to remove specific product impurities, improve process consistency, and increase process redundancy in the purification of the insulin or insulin analog, e.g., insulin lispro.

Chromatography process for purification of insulin and insulin analogs

A method for crystallizing insulin or insulin analogs under alkaline conditions and purifying the insulin or insulin analog crystals by filtering through a filter and drying the insulin or insulin analog crystals captured on the filter to produce crystalline insulin or insulin analog crystal compositions is described. In particular aspects, the method may be used to crystalize insulin glargine.

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Harrisonburg, VA, United States of America

Allison D Ortigosa