Biopharmaceutical Excipient Manufacturing – Current Scenario and Future Trends

Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, vaccines and gene therapies), by the US FDA, have steadily risen.
In fact, over 8,000 biological pharmaceutical products are currently under clinical investigation worldwide. Given the evident benefits of biologics over small molecule drugs (including high efficacy, target specificity and favorable safety profiles), the biopharmaceutical market is poised to witness continued and consistent growth over the next several years. However, biological therapeutics are inherently less stable than small molecules and, hence, more prone to degradation by several physical and chemical degradation mechanisms. Therefore, a variety of excipients, which are pharmacologically inert substances themselves, are used to stabilize biologics during the manufacturing process and storage.

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