Merck Sharp + Dohme Corp.

Mark C Sleevi

Allison D Ortigosa

Michael Patrick Coleman

Kartoa Chow

Michael A Rauscher

Shibu T George

Jack Lile

William L Perry

Douglas S Watson

Rebecca A Chmielowski

Kathryn M Story

Bryn Grimison

Luis Sierra

Allison C Ortigosa

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 producing recombinant trypsin from prokaryote host cells in high yield and high specific activity is described. In particular, a process for producing recombinant trypsin fromis described.

Process for producing recombinant trypsin

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 for refolding recombinant chymotrypsin produced from prokaryote host cells is described. In particular, the present invention provides a process for refolding recombinant chymotrypsin produced fromis described.

Process for refolding recombinant chymotrypsin

A method for crystallizing insulin or insulin analogs under alkaline conditions in the presence of zinc, purifying the crystals by filtering through a filter, and drying the crystals captured on the filter to produce crystalline insulin or insulin analog compositions is described. Method has been exemplified with insulin lispro.

Method for preparing crystalline insulin or insulin analog compositions

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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Longmont, CO, United States of America

Mark C Sleevi