Once limited to a few naturally derived medicinal substances such as vaccines and blood products, biologics and biopharmaceuticals have come to encompass a diversity of treatments including recombinant proteins and enzymes, monoclonal antibodies, and gene-, cell-, and tissue-based therapies.
The composition of many biologics can be highly complex, which often poses challenges related to their proper characterization. Coupled with the increasing globalization of pharmaceutical supply chains, the need for manufacturers, suppliers, and regulators to ensure the quality of biologic drugs becomes amplified.
As the “yardsticks” against which manufacturers test drug substances and products for their appropriate quality, identity, strength, and purity, standards for medicines play an important role in helping to protect public health. The U.S. Pharmacopeial Convention (USP)—a private, nonprofit scientific organization that works closely with the U.S. Food and Drug Administration—develops quality standards that apply under federal law to drugs (including biologics) sold or manufactured in the U.S.; enforcement of these standards is the responsibility of the FDA.
While historically focused on conventional small molecule drugs synthesized through chemistry routes, USP has been working aggressively to develop a portfolio of quality standards for biologics given their expanding role in treating a growing range of diseases. As more biologics enter the therapeutic marketplace, the biopharmaceutical community will become increasingly reliant on public quality standards that can address the functional and structural complexity of biologics as well as the analytical challenges associated with their characterization.
In response to this need, USP’s approach to quality standards for biologics includes guidance on bioassays and biological potency, an emphasis on quality attributes at the product class level, and an ongoing review of attributes associated with unique and emerging technologies.