Merck Sharp + Dohme Corp.

Michael A Rauscher

Allison D Ortigosa

Mark C Sleevi

Michael Patrick Coleman

Kartoa Chow

Shibu T George

Douglas S Watson

David J Roush

Kathryn M Story

Christopher H Smith

Martin Chandler

Sean S Gant

Matthew Petroff

Michael J Iammarino

Kristi Kerchner

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

The use of two tandem microfiltration (MF) steps in a process for making recombinant insulin is described. The two MF steps in a single downstream purification unit operation reduce both soluble and insoluble impurities and exchange the insulin product into a suitable buffer for downstream purification.

Process for preparing recombinant insulin using microfiltration

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

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Garwood, NJ, United States of America

Michael A Rauscher