Patents by Inventor Nitesh Dave
Nitesh Dave has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Patent number: 9241908Abstract: 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.Type: GrantFiled: October 16, 2008Date of Patent: January 26, 2016Assignee: BIOCON LIMITEDInventors: Anand Khedkar, Sharath Kumar Mallapura Rangappa, Ramesh Subramani, Nitesh Dave, Devesh Radhakrishnan, Sundaresh Shankar, Sudheer Chivukula, Ranjith Ramakrishna, Shanmugam Thandava Murthy, Harish Venkatraman Pai, Nilanjan Sengupta, Ramakrishnan Melarkode, Harish Iyer
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Patent number: 8802816Abstract: 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 Pichia pastoris. 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.Type: GrantFiled: April 3, 2008Date of Patent: August 12, 2014Assignee: Biocon LimitedInventors: Partha Hazra, Nitesh Dave, Vivekanandan Kannan, Sanjay Tiwari, Anuj Goel, Harish Iyer, Nita Roy, Krishnamurthy Venkatesan, Anoop Vasudevan, Anupama Jagadish, Goldy Sachdev, Mukesh Babuappa Patale
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Patent number: 8778659Abstract: The disclosure relates to method of reducing O-glycosylation levels of the insulin or insulin analog precursor molecule produced by Pichia sp. The present disclosure provides genetically engineered knock-out strains of methylotrophic yeast including Pichia and especially Pichia pastoris by 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).Type: GrantFiled: March 29, 2010Date of Patent: July 15, 2014Assignee: Biocon LimitedInventors: Nagaraj Govindappa, Komal Kanojia, Krishnamurthy Venkatesan, Nitesh Dave, Mukesh Babuappa Patale, Sanjay Tiwari, Kedarnath N. Sastry, Harish Iyer
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Publication number: 20120309935Abstract: The disclosure relates to method of reducing O-glycosylation levels of the insulin or insulin analog precursor molecule produced by Pichia sp. The present disclosure provides genetically engineered knock-out strains of methylotrophic yeast including Pichia and especially Pichia pastoris by 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).Type: ApplicationFiled: March 29, 2010Publication date: December 6, 2012Applicant: Biocon LimitedInventors: Nagaraj Govindappa, Komal Kanojia, Krishnamurthy Venkatesan, Nitesh Dave, Mukesh Babuappa Patale, Sanjay Tiwari, Kedarnath N. Sastry, Harish Iyer
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Publication number: 20120178900Abstract: The present disclosure demonstrates the utility of ion pairing agents in the preparative scale of purification. More particularly, the disclosure relates to the usage of ion pairing agents in RP preparative linear chromatography enabling high purity of the desired end product. The disclosure shows that ion-pairing agents have dramatic effect on desired purity of polypeptides.Type: ApplicationFiled: August 9, 2010Publication date: July 12, 2012Applicant: BIOCON LIMITEDInventors: Nitesh Dave, Krishana Chaitanya Gulla, Sundaresh Shankar, Harish Iyer
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Publication number: 20120123089Abstract: The instant disclosure provides a method for purification of peptides by chromatographic techniques. The proposed methodology will help in addressing the problems associated in purifying biological protein products emerging from the evolving biotechnology industry.Type: ApplicationFiled: July 8, 2010Publication date: May 17, 2012Applicant: BIOCON LIMITEDInventors: Nitesh Dave, Devesh Radhakrishnan, Sundaresh Shankar, Krishanachaitanya Gulla, Harish Iyer
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Patent number: 8058391Abstract: 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 Pichia. 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—CH2—CH2—(OCH2CH2)3—OCH3.Type: GrantFiled: October 13, 2005Date of Patent: November 15, 2011Assignee: Biocon LimitedInventors: Nitesh Dave, Partha Hazra, Anuj Goel, Nita Roy, Anand Khedkar, Harish Iyer, Gautam Krishnan, H. S. Manjunath, Shrikumar Suryanarayan, Govindasamy Manikam, Goldy Sachdev, Mayank Garg
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Publication number: 20110236925Abstract: 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 Pichia pastoris. 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.Type: ApplicationFiled: April 3, 2008Publication date: September 29, 2011Applicant: BIOCON LIMITEDInventors: Partha Hazra, Nitesh Dave, Vivekanandan Kannan, Sanjay Tiwari, Anuj Goel, Harish Iyer, Nita Roy, Krishnamurthy Venkatesan, Anoop Vasudevan, Anupama Jagadish, Goldy Sachdev, Mukesh, Babuappa Patale
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Patent number: 7977454Abstract: 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.Type: GrantFiled: July 8, 2005Date of Patent: July 12, 2011Assignee: Biocon LimitedInventors: Partha Hazra, Manjunath Hadavanahalli Shivarudraiah, Anand Khedkar, Harish Iyer, Nitesh Dave, Gautam Krishnan, Shrikumar Suryanarayan
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Publication number: 20110020871Abstract: 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 Pichia. 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—CH2—CH2—(OCH2CH2)3—OCH3.Type: ApplicationFiled: October 13, 2005Publication date: January 27, 2011Applicant: BIOCAN LIMITEDInventors: Nitesh Dave, Partha Hazra, Anuj Goel, Nita Roy, Anand Khedkar, Harish Iyer, Gautam Krishnan, H.S. Manjunath, Shrikumar Suryanarayan, Govindasamy Manikam, Goldy Sachdev, Mayank Garg
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Publication number: 20100317827Abstract: The invention relates, interalia, to the field of purification of peptides, notably cyclic or non-cyclic peptides their analogs or derivatives thereof. More particularly, the invention relates to a simplified and optimized purification process of cyclic peptides from a composition comprising the said peptide and at least one related impurity by chromatographic procedures enabling high yields, selectivity and purity of the desired end product. The improved process is particularly useful for the preparation of eptifibatide, exenatide, atosiban, nesiritide and their respective derivatives and analogs. The polypeptides are prepared in high purity of at least about 96%, and preferably at least about 99%.Type: ApplicationFiled: March 26, 2008Publication date: December 16, 2010Applicant: BIOCON LIMITEDInventors: Nitesh Dave, Krishnamurthy Venkatesan, Ramprabu Nagarajan, Harish Iyer
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Publication number: 20100285143Abstract: 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.Type: ApplicationFiled: October 16, 2008Publication date: November 11, 2010Applicant: BIOCON LIMITEDInventors: Anand Khedkar, Sharath, Kumar, Mallapura Rangappa, Ramesh Subramani, Nitesh Dave, Devesh Radhakrishnan, Sundaresh Shankar, Sudheer Chivukula, Ranjith Ramakrishna, Shanmugam, Thandava Murthy, Harish Venkatraman Pai, Nilanjan Sengupta, Ramakrishnan Melarkode, Harish Iyer
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Publication number: 20080139784Abstract: 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.Type: ApplicationFiled: July 8, 2005Publication date: June 12, 2008Applicant: Biocon LimitedInventors: Partha Hazra, H.S. Manjunath, Anand Khedkar, Harish Iyer, Nitesh Dave, Gautam Krishnan, Shrikumar Suryanarayan