Biocon Limited

Nitesh Dave

Harish Iyer

Anand Khedkar

Partha Hazra

Sanjay Tiwari

Shrikumar Suryanarayan

Anuj Goel

Mukesh Babuappa Patale

Krishnamurthy Venkatesan

Nita Roy

Goldy Sachdev

Gautam Krishnan

Ramakrishnan Melarkode

Kedarnath Nanjund Sastry

Nagaraj Govindappa

Harish Venkatraman Pai

Mayank Kumar Garg

Manjunath Hadavanahalli Shivarudraiah

Komal N Kanojia

Nilanjan Sengupta

H S Manjunath

Anupama Jagadish

Govindasamy Manikam

Ranjith Ramakrishna

Anoop Vasudevan

Vivekanandan Kannan

Shanmugam Thandava Murthy

Sudheer Chivukula

Sundaresh Shankar

Devesh Radhakrishnan

Ramesh Subramani

Sharath Kumar Mallapura Rangappa

Sharath Kumar Rangappa

Komal Kanojia

Krishana Chaitanya Gulla

Mayank Garg

The invention relates to improvised pharmaceutical compositions permitting ingestion via oral delivery of proteins/peptides or their conjugates, and/or cation-insulin conjugate complexes demonstrating desirable pharmacokinetic profiles and potency in efficacy models of diabetes in dogs and humans. A preferred formulation comprises 0.01%-20% w/w of insulin, insulin compound conjugates and/or cation insulin conjugates, 10%-60% w/w of one or more fatty acid components selected from saturated or unsaturated C4-C12 fatty acids and/or salts of such fatty acids and additionally contains optimal amounts of other pharmaceutically suitable polymer excipients which permit improved solubility, dissolution rate and effective bioavailability of poorly water soluble compositions and consistent in-vivo release profiles upon scalability during manufacture. A further aspect of the invention features the process of preparing the aforesaid formulations.

Orally administrable solid pharmaceutical composition and a process thereof

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 disclosure relates to method of reducing O-glycosylation levels of the insulin or insulin analog precursor molecule produced bysp. The present disclosure provides genetically engineered knock-out strains of methylotrophic yeast includingand especiallyby disruption of Protein mannosyl transferase (PMT) genes and rendering them capable of producing heterologous proteins with reduced glycosylation. Vectors, which comprise coding sequences for PMT1, PMT2, PMT4, PMT5, and PMT6 genes, for transforming methylotrophic yeasts are contemplated by the present disclosure. PMT inactivated strains of this disclosure have been deposited at MTCC, Chandigarh. The strains are PMT1/GS115 (MTCC 5515), PMT4/GS115 (MTCC 5516), PMT5/GS115 (MTCC 5517) and PMT6/GS115 (MTCC 5518).

Method of reducing glycosylation of proteins, processes and proteins thereof

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

The present invention discloses a process for making an insulin-oligomer conjugate as a one-pot reaction by conjugation of insulin-ester with an activated oligomer wherein simultaneous deblocking and conjugation is carried out.

Preparation of insulin conjugates

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Karnataka, India

Nitesh Dave