Biocon Limited

Goldy Sachdev

Harish Iyer

Anuj Goel

Partha Hazra

Nitesh Dave

Nita Roy

Sanjay Tiwari

Shrikumar Suryanarayan

Anand Khedkar

Mukesh Babuappa Patale

Mayank Kumar Garg

Gautam Krishnan

Krishnamurthy Venkatesan

Anoop Vasudevan

Anupama Jagadish

H S Manjunath

Govindasamy Manikam

Vivekanandan Kannan

Mayank Garg

The invention relates to methods of separation and/or purification of impurities yielding a purified heterologous protein product devoid of related impurities or with substantially minimal quantities of such glycosylated impurities. More specifically, the invention relates to the identification of glycosylated forms of insulin analogues such as glargine impurities characterized post expression in yeast based systems such as. The invention also relates to methods used to clone gene encoding the protein insulin glargine; inserting the related gene in a suitable yeast host; producing culture of the recombinant strain, stimulating expression of the heterologous polypeptide, its secretion and purification post fermentation and related enzymatic conversions.

Method of obtaining a purified, biologically active heterologous protein

The invention claims a process for making an insulin-oligomer conjugate IN-105. IN-105 precursor having formula G-A-V-R-[B-Chain]-R-D-A-D-D-R-[A-Chain] is cloned and expressed in. The biosynthetic precursor is then conjugated with an activated oligomer. The IN-105 precursor-oligomer conjugate is then treated with protease and purified to afford active insulin-oligomer conjugate of formula insulin-OC&#x2014;CH&#x2014;CH&#x2014;(OCHCH)&#x2014;OCH.

Process for the preparation of insulin conjugate IN-105

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Karnataka, India

Goldy Sachdev