LIQUID INSULIN COMPOSITIONS AND METHODS OF MAKING THE SAME

摘要

Disclosed herein are novel and improved preparations and methods for manufacturing substantially liquid preparations of recombinant human insulin API. The purified recombinant human insulin Active Pharmaceutical Ingredient (API) preparations are substantially free of by-products associated with the lyophilization and/or crystallization. The methods for manufacturing the substantially liquid recombinant human insulin API preparations are provided with optional steps for subjecting the recombinant insulin preparation to lyophilization and/or crystallization. Enhanced yield of recombinant insulin of greater purity are thereby provided according to the present invention. Highly purified formulations of recombinant human insulin of the API insulin preparations disclosed herein are also provided. Stably transformed E. coli cell banks (WCB) capable of expressing the recombinant human insulin are also provided

主权项

1. A highly purified liquid recombinant human insulin as an Active Pharmaceutical Ingredient (API) preparation, the liquid recombinant human insulin having an amino acid sequence that is about 95% homologous with the amino acid sequence of native human insulin, containing 2% or less of a A21 desamino insulin and containing 1% or less non-monomeric insulin species.