Abstract: The present disclosure relates to a bio-manufacturing process that enables continuous production of a therapeutic protein with reduced heterogeneity. The bio-manufacturing process disclosed herein utilizes a multi column chromatography system that performs the unit operations of reducing heterogeneity in a therapeutic protein, capturing the therapeutic protein and inactivating viruses, purifying the therapeutic protein, and polishing the purified therapeutic protein. The process disclosed herein can reduce heterogeneity of a therapeutic protein by reducing a proportion of basic isoforms of the therapeutic protein.

Abstract: The present invention encompasses compounds and composition that inhibit Src kinase and methods of treating or preventing disorders associated therewith. In some embodiments, the invention encompasses compositions and combinations of agents that act synergistically inhibit the growth of cancer cells and particularly the compositions and combinations can be used for the treatment of cancer.

Abstract: The present disclosure relates to an analog of glucagon-like peptide-1 (glp-1) receptor agonist. The present disclosure provides analogs of glucagon-like peptide-1 (glp-1) receptor agonist wherein, the amino acid at position 2 of the glucagon-like peptide-1 (glp-1) receptor agonist is replaced with D-Alanine. The analogs of glucagon-like peptide-1 (glp-1) have one or more properties of prolonged half-life, better pharmacokinetic profile, retained biological activity, and being advantageous for relieving the patient's burden by reducing the dosing frequency and dose. The present disclosure further provides processes for preparing synthetic glucagon-like peptide-1 (glp-1) analogs.

Abstract: The present invention relates to an automated integrated continuous bioprocess system and bioprocess that are capable of continuously producing therapeutic protein in an uninterrupted manner and scalable from laboratory to manufacturing scale. The present invention provides an automated integrated continuous bioprocess system and bioprocess for producing therapeutic protein, in which the system and process is controlled with one or more control system selected from supervisory control and data acquisition (SCADA) control system (110), proportional integral derivative (PID), programmable logic circuit (PLC), industrial PC (IPC), distributed control system (DCS), message relaying system and automated UPLC/HPLC sampling for online testing to run the system and process and in an uninterrupted manner and continuously produce therapeutic protein.

Abstract: A process for the preparation of plecanatide. Specifically, an improved process for preparation of plecanatide using a non-linear solid phase peptide synthesis. In particular, the process for preparation of plecanatide involves solid phase synthesis of peptide fragments of five amino acid units using 2-chlorotrityl chloride (2-ClTrt) resin and eleven amino acid unit using Wang resin.

Abstract: The present disclosure relates to providing an engineered CHO cell line wherein the two essential metabolic genes are knocked out. Particularly, the present invention relates to a double knockout CHO cell line (DHFR?/? and GS?/?) with disrupted Dihydrofolate Reductase (DHFR) and Glutamine Synthetase (GS) genomic loci. The double knockout CHO cell line (DHFR?/? and GS?/?) being suitable for expression of monoclonal antibodies, dimeric therapeutic proteins, Fab, single chain fragments, or the like. The present disclosure also provides method of generation of a double knock out CHO cell line (DHFR?/? and GS?/?) using gene selection and/or manipulating techniques such as CRISPR/Cas9 system, Zinc Finger Nuclease, TALEN, or the like. The present disclosure further provides method of selection of clones and production of therapeutic proteins of interest with increased titre.

Abstract: The present invention relates to succinic acid and its derivative(s) of Formula (I), their pharmaceutically acceptable salts, polymorphs, solvates, hydrates, co-crystals, isomers and solvates thereof as an active pharmaceutical ingredient for the treatment of haematological disorder(s). The present invention further relates to compounds of Formula (I), for the treatment of disorders selected from dengue, idiopathic thrombocytopenic purpura (ITP), anaemia and chemotherapy induced myelosuppression. The present invention also relates to use of succinic acid for the treatment of haematological disorder(s), wherein succinic acid is extracted from Papaya leaves. The present invention also provides pharmaceutical compositions comprising succinic acid and its derivative(s) of Formula I and methods of treating haematological disorder(s).

Abstract: A novel and thermostable lyophilized pharmaceutical composition of Romiplostim (Fcpeptide fusion protein) along with buffer, bulking agent, stabilizer, and surfactant at pH range of 4.0-6.0.

Abstract: The present invention relates to a liquid pharmaceutical composition comprising an anti-TNF? antibody, buffer, stabilizer, and surfactant.

Abstract: A liquid pharmaceutical composition having an anti-TNF? antibody, a buffer, a stabilizer, and a surfactant.

Abstract: The present disclosure relates to a bio-manufacturing process that enables continuous production of a therapeutic protein with reduced heterogeneity. The bio-manufacturing process disclosed herein utilizes a multi column chromatography system that performs the unit operations of reducing heterogeneity in a therapeutic protein, capturing the therapeutic protein and inactivating viruses, purifying the therapeutic protein, and polishing the purified therapeutic protein. The process disclosed herein can reduce heterogeneity of a therapeutic protein by reducing a proportion of basic isoforms of the therapeutic protein.

Abstract: A polynucleotide sequence and a method for Ranibizumab cloning, expression and production having better yield and biologically active protein.

Abstract: A novel and thermostable lyophilized pharmaceutical composition of Romiplostim (Fcpeptide fusion protein) along with buffer, bulking agent, stabilizer, and surfactant at pH range of 4.0-6.0.

Abstract: A liquid pharmaceutical composition having an anti-TNF? antibody, a buffer, a stabilizer, and a surfactant.

Abstract: A polynucleotide sequence and a method for Ranibizumab cloning, expression and production having better yield and biologically active protein.

Abstract: Provided are systems comprising delivery vehicles for the stable storage of immobilized proteins, e.g., protein therapeutics, in a form amenable to administration, such as by injection or infusion, in combination with an elution fluid. Also provided are proteins adsorbed to chromatography media in a form compatible with a one-step administration of the protein. Exemplary delivery vehicles are pre-filled syringes and pre-filled infusion modules; exemplary proteins are antibodies useful in therapy. Also provided are methods of producing the immobilized proteins and methods of using the immobilized proteins, e.g., protein therapeutics.

Abstract: The present invention is generally directed to methods of producing an increase in the enrichment or recovery of preferred forms of IgG proteins. More particularly, the invention relates to subjecting preparations of such recombinant IgG proteins with a reduction/oxidation coupling reagent and optionally a chaotropic agent.