Effect of Lyophilization on Stability of PEG-Protein Conjugate: A Case Study with Peginterferon alfa-2b

The purpose of the present study was to develop stable lyophilized formulation peginterferon alfa-2b which is acquiescent short lyophilization process. evaluates effect buffering components and cryoprotectant(s) on depegylation in combination with Finally, a process identified can produce pharmaceutical form without any during long-term storage. Formulations were analyzed mainly for by HP-size exclusion chromatography in-vitro antiviral activity. Residual moisture content product also used as key indicating parameter check its role respect upon storage under various temperature conditions. It observed that when formulated presence cryoprotectant like sucrose requires longer about 5 days, irrespective used, reduce level residual thereby depegylation. A high concentration lactose developed withstand stresses exerted protein-polymer conjugate phases significant 48 hours be utilized through produced against required cryoprotectant, essential from commercial point view costly