Abstract

Numerous obstacle crops up in the path of developing efficient protein-based formulations and administration in humans for their therapeutic effect. The challenges starts from protein synthesis to it’s handling procedure, stability, storage, excipients compatibility, scale up, analysis, validation, tissue targeting, in-vivo bioavailability, immunogenic reactions, etc., In the field of protein drug development, various novel methods and techniques have been evolved and continuing the research to face those challenges to bring out potential drug formulations and its delivery system to the market. It is vital to develop various strategies for protecting the integrity of proteins, increasing their availability in the body, decreasing immunological responses, transporting and target to particular tissues or cells. This current review focuses on to understand the problems, challenges encountering and the best approaches for protein based drug formulation development. It is one of roadmap to plan various research activities for continual improvement of therapeutic applications of newly developing protein drugs in this area.

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