Integration of novel approaches and strategies to modify protein drug products is an important aspect. Advancements in recombinant protein technologies have allowed drug manufacturers and developers to adjust required functional characteristics of proteins of interest while maintaining product efficacy and safety.

Various recombinant technologies are currently in use to increase the half-life, functionality, and targeting of novel therapeutic protein drugs and increase product purity and volume. For instance, protein conjugation and derivatization methods, including albumin-fusion15, PEGylation and Fc-fusion are currently being used to extend a drug’s circulating half-life.

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Monoclonal antibodies (mAbs) are most commonly used recombinant therapeutic products. The production of most monoclonal antibody products is easily amenable to effective platform-based approaches as antibodies are highly specific and the risk of unexpected safety issues in human clinical trials of mAb products is less as compared to other types of therapeutic products. The constant evaluation of monoclonal antibody drugs in new and expanded clinical indications results in constant demand for products in clinical studies ensuing increased sales in newly approved indications.

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