Monographs in USP–NF include tests, procedures for those tests, and acceptance criteria for determining the quality of a specific article of commerce. In addition to monographs for drug substances, drug products, and excipients, USP–NF includes general chapters, which are necessary to demonstrate compliance with particular monographs or provide information to help guide companies in their quality strategies.
Some specific USP–NF general chapter topics for biologics cover the design, validation, and analysis of bioassays; quality attributes of protein A; cellular and tissue-based products; gene therapy products; growth factors and cytokines; ancillary materials in cell manufacturing; and immunogenicity testing. Also included are general chapters on critical issues related to bacterial endotoxins; sterility testing; microbiological and bioburden control; injectibles; supply chain integrity and more.
Currently USP is working vigorously to develop new chapters on mono- and oligossacharide analysis; residual DNA analysis; host cell protein analysis; protein determination analysis; vaccines; excipient performance characteristics and more.
In support of procedures included in USP–NF monographs and general chapters, USP offers a growing list of highly characterized Reference Standards for method development, validation, and testing. USP’s catalog of supporting Reference Standards includes insulins and other peptides; low molecular weight heparins; endotoxins; excipients; amino acids and an expanding list of articles for biomanufacturing. Currently in development are Reference Standards for fetal bovine serum, filgrastim, IL-4, and oligosaccharide mixtures.