Abstract:
The present invention discloses a cell culture method for producing a CTLA-4 fusion protein composition comprising a target % of monomer species of the fusion protein, wherein the cell culture method comprises addition of cysteine in the cell culture medium. The invention further discloses a cell culture process to produce CTLA-4 fusion protein composition with target % of monomer species involving a dual temperature shift with addition of cysteine. Also, the present invention provides a CTLA-4 fusion protein composition comprised of target % of monomer species and/or homodimer species of the CTLA-4 fusion protein.
Abstract:
The present invention discloses a therapeutic composition comprising fusion protein with reduced heterogeneity in the glycosylation profile of the protein and methods thereof. More particularly the invention provides the composition with reduced heterogeneity in the glycosylation profile. By reducing heterogeneity, the resultant preparation is expected to exhibit superior, consistent results in terms of safety, purity and potency. The invention is of particular importance as it can form the part of the critical quality attributes (CQA) that help in ensuring batch-to-batch consistency and predicted shelf-life of complex protein molecules.
Abstract:
The present invention discloses an optimal lyophilization method to prepare a room-temperature-stable freeze-dried formulation of an anti-α4β7 antibody wherein the lyophilized anti-α4β7 antibody formulation obtained from the said method exhibits stability at room temperature for at least three months and reconstituted anti-α4β7 antibody formulation exhibits stability at room temperature at least for 24 hours.
Abstract:
The present invention provides co-crystals of Deutetrabenazine and Vanillin, process for the preparation of co-crystals and pharmaceutical composition comprising said co-crystals of Deutetrabenazine. The co-crystals of Deutetrabenazine and Vanillin is non-hygroscopic, chemically and physically stable and suitable for pharmaceutical formulation and its use in the treatment of tardive dyskinesia and chorea associated with Huntington's disease.
Abstract:
The present invention provides a process for the preparation of Lenvatinib or its salts thereof. The present invention also provides a crystalline form of Lenvatinib, which is characterized by the PXRD pattern as shown in figure 1. The present invention also provides a process for their preparation and pharmaceutical composition thereof.
Abstract:
The present application relates to a process for the preparation of crystalline form A of palbociclib having specific surface area more than 2m 2 /g comprising one-pot process for the preparation of compound of formula (IV). The present application further relates to the preparation of acid-addition salts of palbociclib and their use for the synthesis of crystalline form A of palbociclib having specific surface area more than 2 m 2 /g.
Abstract:
The present application relates to a process for preparation of tert-butyl ( R )-(1-([1,1'-biphenyl]-4- yl)-3-hydroxypropan-2-yl)carbamate (IA). The compound of formula (IA) may be used as an intermediate for the preparation of sacubitril.
Abstract:
The present application relates to a regioselective and stereoselective processes for the preparation of dehydroepiandrosterone (DHEA) and processes for its intermediates.