January 24, 2017 Article in American Pharmaceutical Review. Vol 20, Issue 1, Jan/Feb 2017

“Production Challenges for Complex Biologics: Fusion Proteins”

In the last two years five novel fusion proteins were approved by the FDA, raising the total number of marketed therapeutic fusion proteins to thirteen. Several more are in late stage clinical trials and will probably reach the market soon. This underlines a success story that started in 1998 with the approval of Enbrel® the first fusion protein ever. Fusion proteins are generated by artificially joining two or more genes that originally code for separate proteins by genetic engineering. The result is a single polypeptide with functional properties of both parental proteins. These combinations of unrelated domains do not occur in nature and are solely based on intelligent human design. Often the components of fusion proteins are derived from different cell types or cellular locations that do not necessarily fit together in terms of physicochemical properties such as isoelectric point, charge densities and hydrophobicity which ultimately lead to manufacturing challenges. Here, the three areas, design, upstream and downstream processing, which contribute mostly both to the challenges and the respective solutions, are discussed.

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