Biologics Present New Challenges for Packaging
As new dosage forms and pharmaceutical drug products have evolved over recent decades, container closure systems used to make, store, transport, and administer finished products to patients have needed to keep pace with those changes.
Perhaps one of the most transformative trends in pharma in recent years has been the explosive growth in biologic drug development. While these medicines have opened doors for treating many different cancers, autoimmune disorders, and chronic diseases such as diabetes, biologics have presented some new challenges related to packaging systems.
Biologic drugs are not a new concept—legacy biologics such as heparin, insulin, and some vaccines have been available for therapeutic use for some time. However, more modern biologics—including monoclonal antibodies, protein therapies and cell- and tissue-based regenerative medicines—are prompting manufacturers to examine the impact of packaging material selection early in the product development process. By considering these factors early on, manufacturers can help to ensure the safety and effectiveness of their products in the final packaging system.
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Learn more about how USP supports industry innovation of global biologics and biotechnology by visiting: http://www.usp.org/usp-manufacturers/biologics-biotechnology