The present disclosure discusses a method of separating and/or purifying acidic peptides by the use of a mobile phase having a pH greater than or about equal to the isoelectric point of one or more of the metal oxides in the flow path.

The present invention provided the techniques and recipes for enhancing recombinant peptide production in microorganism like E. coli, Saccharomyces cerevisiae, Pichia pastoris and Bacillus subtilis. The designs of fusion protein with a polypeptide and high cell density fermentation process to over express the peptides are given. Methods for separation of polypeptides from fusion protein and methods for isolation and purification of peptides are mentioned. This invention also provides an uncomplicated and unique purification processes for manufacturing of Teriparatide, Liraglutide precursor and Semaglutide precursor with purifies of >98%.

The present invention provided the techniques and recipes for enhancing recombinant peptide production in microorganism like E. coli, Saccharomyces cerevisiae, Pichia pastoris and Bacillus subtilis. The designs of fusion protein with a polypeptide and high cell density fermentation process to over express the peptides are given. Methods for separation of polypeptides from fusion protein and methods for isolation and purification of peptides are mentioned. This invention also provides an uncomplicated and unique purification processes for manufacturing of Teriparatide, Liraglutide precursor and Semaglutide precursor with purifies of >98%.

A process for providing a mono-PEGylated protein composition is provided. The process is particularly suitable for providing mono-PEGylated erythropoietin composition. The process comprises subjecting a mixture comprising non-PEGylated, mono-PEGylated and oligo-PEGylated to a hydrophobic interaction chromatography process.

A process for providing a mono-PEGylated protein composition is provided. The process is particularly suitable for providing mono-PEGylated erythropoietin composition. The process comprises subjecting a mixture comprising non-PEGylated, mono-PEGylated and oligo-PEGylated to a hydrophobic interaction chromatography process.

The present application relates to improved and effective purification processes and also relates to method of increasing the solubility of for GLP-1 analog and its derivatives particularly Liraglutide. The purification process of present application is advantageous not only in terms of providing the highly pure peptide chemically but also in terms of affording peptide drug substance which is having good physical stability even at a large scale during holding or in-use period, while making drug substance compatible for formulation.

The present application relates to improved and effective purification processes and also relates to method of increasing the solubility of for GLP-1 analog and its derivatives particularly Liraglutide. The purification process of present application is advantageous not only in terms of providing the highly pure peptide chemically but also in terms of affording peptide drug substance which is having good physical stability even at a large scale during holding or in-use period, while making drug substance compatible for formulation.

Aspects of the present disclosure relate to systems and methods for manufacturing biologically-produced pharmaceutical products. Some of the systems described herein comprise an upstream component comprising a bioreactor and at least one filter (e.g., a filter probe) integrated with a downstream component comprising a purification module comprising at least a first partitioning unit and a second partitioning unit. In some embodiments; these integrated biomanufacturing systems may be operated under continuous or conditions and may be capable of efficiently producing pure, high-quality pharmaceutical products.

Aspects of the present disclosure relate to systems and methods for manufacturing biologically-produced pharmaceutical products. Some of the systems described herein comprise an upstream component comprising a bioreactor and at least one filter (e.g., a filter probe) integrated with a downstream component comprising a purification module comprising at least a first partitioning unit and a second partitioning unit. In some embodiments; these integrated biomanufacturing systems may be operated under continuous or conditions and may be capable of efficiently producing pure, high-quality pharmaceutical products.

The objective of the present invention is to provide a method capable of purifying a virus or a virus-like particle easily. The method for purifying a virus or a virus-like particle according to the present invention is characterized in comprising the step of contacting a liquid comprising the virus or the virus-like particle with a water-insoluble inorganic compound, wherein the water-insoluble inorganic compound comprises one or more elements selected from magnesium, calcium and aluminum.