Abstract: The invention provides stable pharmaceutical formulation comprising a protein drug conjugate along with one or more suitable excipient(s) such that the formulation is devoid of any buffer components and methods of making the same. The protein drug conjugate according to the present invention is antibody drug conjugate, preferably trastuzumab maytansinoid conjugate. Suitable excipient(s) according to the present invention is selected from suitable bulking agents, suitable tonicity modifiers, suitable stabilizers and the like.

Abstract: The invention provides process for preparing antibody-drug conjugates, preferably trastuzumab maytansinoid conjugate linked via non-cleavable linker comprising performing the conjugation reaction at lower temperature than ambient and/or at lower pH condition than neutrality. The process according to the present invention comprises conjugating the linker modified antibody with cytotoxic drug, preferably the SMCC-modified trastuzumab with a cytotoxic drug, preferably maytansinoid at a temperature lower than 20° C. and at a pH lower than 6.0, and thereby preparing an antibody-drug conjugate, preferably trastuzumab maytansinoid conjugate, T-DM1.

Abstract: The present invention provides an improved method for the purification of monoclonal antibody from cell culture. Process of purification of the desired monoclonal antibody comprises affinity, hydrophobic interaction and optionally ion exchange column chromatography. It provides more than 99% purity of the desired monoclonal antibody.

Abstract: The present invention relates to improved method for purification of a recombinant parathyroid hormone (rhPTH1-34 or teriparatide), said process for purification of parathyroid hormone comprising following essential steps: (a) Enzymatic cleavage; (b) anion exchange chromatography, followed by other suitable purification steps; wherein step (a) and (b) can be carried out in any order.

Abstract: The present invention provides an improved method for the purification of monoclonal antibody from cell culture. Process of purification of the desired monoclonal antibody comprises affinity, hydrophobic interaction and optionally ion exchange column chromatography. It provides more than 99% purity of the desired monoclonal antibody.