Abstract: The present invention provides for methyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt, a novel process for the preparation of crystalline Form B of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt.

Abstract: The present invention discloses rapid and cost-effective method of de-glycosyation of a glycoprotein, wherein, glycoprotein is combined with anionic surfactant and reducing agent and non-ionic surfactant in order to obtain stable denatured glycoprotein. An endoglycosidase is further added to denatured glycoprotein to cleave N-linked glycans in order to obtain de-glycosylated protein. A rapid tool for assessing the protein conformation by partial de-glycosylation is also presented wherein the partial de-glycosylated protein is analysed using capillary electrophoresis (CE-SDS).

Abstract: The present invention provides an in vitro method for detecting the presence of neutralizing antibodies against recombinant human insulin (rHI) in human serum. It also provides a kit for an in vitro method of detection of the presence of recombinant human insulin (rHI) neutralizing antibodies.

Abstract: The present invention provides for novel co-crystals of lenalidomide. The present invention particularly provides for novel cocrystals of lenalidomide with Resorcinol, Methyl paraben and Saccharin. The present invention also provides for the processes for the production of cocrystals of lenalidomide with Resorcinol, Methyl paraben and Saccharin. The present invention further provides for processes for the preparation of crystalline anhydrous lenalidomide Form IV.

Abstract: The present invention relates to the efficient solid-phase synthesis of liraglutide represented by Formula-I. The present invention relates to an efficient process for the preparation of liraglutide by sequential coupling employing solid phase approach. It involves sequential coupling of protected amino acids to prepare backbone of liraglutide and upon completion of linear sequence, synthesis was extended from lysine side chain by adding ?-glutamic acid and palmitic acid, followed by removal of protective groups, cleavage of the peptide from solid support and purification of crude liraglutide obtained. The present invention also involves the usage of inorganic salts during the coupling, wash with HOBt in DMF solution after Fmoc-deprotection step to suppress the aggregation of peptides and ensure reactions are going for completion, and thus avoid deletion sequences and improve the process yield.

Abstract: The present invention provides for the dasatinib-thymine co-crystal and dasatinib-adenine co-crystal. The present invention further provides dasatinib-butanediol solvate. The present invention further provides for crystalline dasatinib-(±)-1, 2-Butanediol, crystalline dasatinib (R)-1, 2-Butanediol, crystalline dasatinib (S)-1, 2-Butanediol and crystalline dasatinib (±)-2, 3-Butanediol and processes for preparation thereof. The present invention also provides for a process for preparation of amorphous dasatinib using dasatinib-butanediol solvate. The present invention further provides for the preparation of anhydrous dasatinib. The present invention also provides for a process for preparation of dasatinib monohydrate from anhydrous dasatinib.

Abstract: The present invention provides novel crystalline forms B1 & B2 of linagliptin intermediate of structural formula V and methods for production of novel crystalline form of linagliptin intermediate represented by the following structural formula V.

Abstract: The present disclosure relates to methods for treatment and prevention of disease conditions mediated by T-helper 17 (Th17) and/or T-helper 1 (Th1) T lymphocytes (T cells). In particular, the present disclosure relates to use of anti-CD6 antibody for treatment of disease conditions mediated by auto-reactive Th17 and Th1 T lymphocytes. The methods of the present disclosure further have utility in methods for modulating an immune response by suppressing production of the cytokine IL-23R, thereby decreasing inflammation mediated by Th17 cells.

Abstract: The present invention provides for crystalline Form B1 of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenyl-methyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt, crystalline Form B2 of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt, a novel process for the preparation of crystalline Form B of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt.

Abstract: The present invention provides an industrial method production of amorphous posaconazole. The present invention also relates to a method for production of the posaconazole via and novel crystalline forms of posaconazole intermediate. More particularly the present invention relates to novel crystalline forms of posaconazole intermediate and methods for production of novel crystalline forms of posaconazole intermediate represented by the following structural formula III Which is key intermediate in the production of posaconazole. The present invention also provides for the one pot process for the preparation of amorphous posaconazole using novel crystalline forms of benzyl posaconazole.

Abstract: The present invention provides for the dasatinib-thymine co-crystal and dasatinib-adenine co-crystal. The present invention further provides dasatinib-butanediol solvate. The present invention further provides for crystalline dasatinib-(±)-1,2-Butane diol, crystalline dasatinib (R)-1,2-Butanediol, crystalline dasatinib (S)-1,2-Butanediol and crystalline dasatinib (±)-2,3-Butanediol and processes for preparation thereof. The present invention also provides for a process for preparation of amorphous dasatinib using dasatinib-butanediol solvate. The present invention further provides for the preparation of anhydrous dasatinib.

Abstract: The present invention relates to a humanized IgG1 isotype anti-CD6 antibody (T1h) that binds to the Scavenger receptor cysteine-rich (SRCR) domain 1 (D1) of CD6 present on the surface of thymic epithelial cells, monocytes, activated T cells and a variety of other cells types.

Abstract: The present invention provides a process for the preparation of Teriflunomide (Formula-I). The present invention describes the synthesis of Teriflunomide without isolating the intermediate Leflunomide. Teriflunomide is prepared from 5-Methyl isoxazole-4-carboxylic acid by converting to its acid chloride and coupling with 4-trifluoromethyl aniline to obtain Leflunomide (which is not isolated) followed by ring opening reaction using aq. Sodium Hydroxide to form Teriflunomide. In other words, the process is telescoped from 5-methylisoxazole-4-carbonyl chloride.

Abstract: The present invention provides an industrial method production of amorphous posaconazole. The present invention also relates to a method for production of the posaconazole via and novel crystalline forms of posaconazole intermediate. More particularly the present invention relates to novel crystalline forms of posaconazole intermediate and methods for production of novel crystalline forms of posaconazole intermediate represented by the following structural formula III Which is key intermediate in the production of posaconazole. The present invention also provides for the one pot process for the preparation of amorphous posaconazole using novel crystalline forms of benzyl posaconazole.

Abstract: The present invention relates generally to the field of generating fusion proteins to be used in cancer therapy, and more specifically, to nucleotide sequences encoding the fusion proteins, wherein the chimeric fusion proteins comprises at least one targeting moiety and at least one immunomodulatory moiety that counteracts the immune tolerance of cancer cells.

Abstract: The present invention relates to compositions and methods useful for the treatment of lupus using a humanized IgG1 anti-CD6 monoclonal antibody (T1h) that binds to the SRCR domain 1 (D1) of CD6 without blocking the interaction of CD6 with the CD6 ligand Activated Leukocyte Cell Adhesion Molecule (ALCAM).

Abstract: The present invention relates to a method or process for controlling, inhibiting or reducing protein fucosylation in a eukaryote and/or eukaryotic protein expression system. Said method comprises carrying out the protein expression and/or post-translational modification in the presence of an elevated total concentration of manganese or manganese ions.

Abstract: The present disclosure relates to methods for treatment and prevention of disease conditions mediated by T-helper 17 (Th17) and/or T-helper 1 (Th1) T lymphocytes (T cells). In particular, the present disclosure relates to use of anti-CD6 antibody for treatment of disease conditions mediated by auto-reactive Th17 and Th1 T lymphocytes. The methods of the present disclosure further have utility in methods for modulating an immune response by suppressing production of the cytokine IL-23R, thereby decreasing inflammation mediated by Th17 cells.

Abstract: The present invention relates generally to the field of generating fusion proteins to be used in cancer therapy, and more specifically, to nucleotide sequences encoding the fusion proteins, wherein the chimeric fusion proteins comprises at least one targeting moiety and at least one immunomodulatory moiety that counteracts the immune tolerance of cancer cells.

Abstract: The present disclosure relates to a comprehensive model for expression of recombinant peptides by Pichia pastoris. The model uses an easily controllable variable called ‘critical nutrient ratio’ for obtaining a right balance between product synthesis and it's degradation during the fermentation process. The extra cellular concentration of precursor could be increased by about 10 folds and the degradation constants could be reduced by about 10-20 folds for intracellular and extracellular cases respectively by controlling critical nutrient ratio and addition of soya flour hydrolysate and EDTA.