An improved method of chromatographic analysis of protein samples by using reverse phase high performance liquid chromatography is disclosed. In which a chromatographic step is carried out by maintaining column temperature between 4 °C to 15 °C.

The present invention relates to a liquid formulation of a polypeptide containing an Fc domain of an immunoglobulin which is stabilized to maintain the activity of a polypeptide containing an Fc domain for a prolonged period of time.

The invention relates to a process for the purification of Fc containing proteins. A process comprising at least three chromatographic purification steps i.e. protein A affinity chromatography, anion exchange chromatography and hydrophobic interaction chromatography. The invention relates to, in particular, a proces...

The invention relates to the formulations of pegylated interferons. In particular, the invention provides pharmaceutical formulations of pegylated interferons comprising pegylated interferon and pharmaceutically acceptable excipients wherein the formulation is a lyophilized powder

The present invention relates to an aqueous formulation of a follicle stimulating hormone (hFSH) which is stabilized to maintain the activity of hFSH for a prolonged period of time.

The invention relates to a fed-batch fermentation process for high level production of recombinant human growth hormone (rhGH) and its analogs in the form of inclusion bodies. The high level production of inclusion bodies can be achieved by the specific type of fed batch strategy which includes maintaining the parti...

The invention relates to a process for the purification of hyperglocysylated analogue of erythropoietin. A process comprising of at least four chromatographic purification steps i.e. at least two anion exchange chromatographies, at least one hydroxyapatide chromatography and atleast one gel permeation chromatography...

The present invention relates to a formulation of polymer - drug conjugate with dual buffer system to minimize the cleavage between polymer and therapeutic drug. The present invention also relates to a method of preparation of stable pharmaceutically acceptable formulation of polymer - drug conjugates comprising use...

The present invention relates to a method for obtaining recombinant human parathyroid hormone (rHu PTH) ; and in particular, for the purification of a recombinant teriparatide, i.e. PTH (1-34) of the 84 amino acid full-length human parathyroid hormone (hPTH). As per the method, the said purification process begins w...

Interferon conjugate comprising interferon, branched polyethylene glycol with aspartic acid core as a linker in the conjugate.

This invention relates to a process for developing a stable cell line for high level expression of recombinant proteins by co-transfection of two mammalian expression vectors wherein the gene for desired protein of interest (POI) along with signal sequence and reading frame are cloned/ inserted into two vectors inde...

The invention relates to a process for the purification of Fc containing proteins. A process comprising at least three chromatographic purification steps i.e. anion exchange chromatography, cation exchange chromatography and hydrophobic interaction chromatography. In a preferred embodiment, this process does not req...

The invention relates to batch fermentation process for high level production of inclusion bodies i.e. Parathyroid Hormone (PTH). Under the given conditions, the E.coli cells are able to produce very high concentration of Inclusion bodies. High level production of Inclusion bodies can be achieved by batch fermentat...

The present invention relates to pharmaceutical compositions of therapeutic proteins which are selected from the group comprising of naturally occurring or recombinant parathyroid hormone(PTH) and its analogues such as teriparatide PTH (1-34), PTH (1-37), PTH (1-38), PTH (1-41), PTH (1-84) and the like; or their pha...

The present invention relates to a process to control the production of acidic isoforms of recombinant human erythropoietin (rHu EPO). This invention applies to recombinant CHO cells grown as a suspension cells in serum and animal component free cell culture medium in stir-tank bioreactors in a fed-batch mode over a...

The present invention relates to the process(s) for the preparation of Granulocyte Colony-Stimulating Factor or mixture(s) of Granulocyte Colony-Stimulating Factor. Granulocyte Colony-Stimulating Factor (G-CSF) is a glycoprotein, growth factor or cytokine produced by a number of different tissues to stimulate the b...

The invention relates to a process for the purification of gonadotropins. A process comprising of at least four chromatographic purifications steps, i.e. at least one anion exchange chromatography, one cation exchange chromatography, one hydrophobic interaction chromatography and at least one gel permeation chromato...

The prsent invention provides a stable water-in-oil microemulsion pharmaceutical formulation comprising a continuous oil phase and a dispersed aqueous phase containing a biological. The microemulsion formulation of the present invetion is stable under refrigerated conditions, have acceptable organo-leptic properties...

The present invention relates to the process for the preparation of lnterleukin-2 using exponential feeding strategy. The process of the present invention was found to be economically viable and feasible.

The present invention relates to an aqueous formulation of recombinant human gonadotropins which is stabilized to maintain the activity of gonadotropins for a prolonged period of time.

The present invention relates to a composition and method of preparing biodegradable polymer-based delivery system, loaded with peptides and proteins as drugs for its sustained and controlled release over an extended period of time.

NA

The present invention relates to an aqueous formulation of human Gonadotropins which are stabilized to maintain its activity for a prolonged period of time for therapeutic use to guarantee a reasonable shelf life. More specifically, the present invention relates to an aqueous formulation of gonadotropin (e.g. FSH, T...

Compositions of reconstitution medium useful for the reconstitution of the iyophilized formulations containing protein are provided. The composition generally includes amino acid, sugar alcohol, surfactant, tonicity modifier and stabilizer each either alone or in a suitable combination thereof. The reconstitution me...

NOT SUBMITTED

The present invention is directed to a method for inactivating viruses, virus like particles or fragments thereof from purified or partially purified therapeutic proteins/therapeutic solutions. The process comprises the steps of (a) adding stabilizer to solution; (b) adjusting pH of the solution between 3.0 to 4.1 t...

The present invention provides stable pharmaceutical formulations of pegylated interferons comprising pegylated interferon alfa conjugates and phannaceutically acceptable excipients. The formulations of the invention are in the form of lyophilized powder.