Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
Issue link: http://gen.epubxp.com/i/83770
Corporate Capabilities Pharmacopeial Convention T United States Developing Quality Standards for Biologic Drugs he United States Phar- macopeial Conven- tion (USP) is dedi- cated to improving the health of people around the world through public standards and related prod- ucts and services that help ensure the quality, safety, and benefit of medicines. As biologic drugs continue to play an expanding role in the therapeutic arena, USP has worked with scientific lead- ers in the biopharmaceutical community to develop quality standards that support activi- ties in the discovery, develop- ment, manufacturing, and distribution of biologics. About the Organization For nearly 200 years, United States Pharmacopeial Convention (USP) 12601 Twinbrook Pkwy. Rockville, MD 20852 Phone 800.227.8772 301.881.0666 Website www.usp.org Date Founded 1820 Number of Employees More than 700 USP has been developing quality standards for medicines and their ingredients. A nonprofit scientific organization, USP creates both mono- graphs (documentary standards) and reference standards (chemical and biological reference materials) used to test for the identity, strength, quality, and purity of drugs and their ingredi- ents. A manufacturer of a drug product in the U.S. market must conform to any applicable standards published by USP to avoid possible charges of adulteration and misbranding under the U.S. Federal Food, Drug, and Cosmetics Act (FDCA). USP has no role in enforcement of its standards, which is the responsibility of the Food and Drug Administration. USP's Council of Experts—volunteer experts from industry, academia, and regulatory agen- cies as well as practitioners—provide their scien- tific expertise and direction to USP's standards- setting activities. For standards related to biolog- ics, USP experts provide their technical expertise in a wide variety of areas, including naturally derived biologics; recombinant therapeutics; vaccines; bioassays and cell-based assays; and ancillary and process materials. USP's public standards for biologics are con- veyed in its compendia, the United States Phar- macopeia and National Formulary (USP–NF). The FDCA designates the current official ver- sion of USP–NF as the applicable compendial standard for drugs marketed in the U.S., which include biologics approved under the Public Health Service Act. Before becoming official, all standards published in USP–NF go through a public review and comment period during which stakeholders can provide input into USP's proposed standards. Standards under review are published six times a year in the Pharmacopeial Forum—USP's free-access, online publication for receiving comments (www.usp.org/usp-nf/ pharmacopeial-forum). Markets Served USP standards are relevant to large phar- maceutical and biopharmaceutical companies, emerging biotechnology firms, contract manu- facturing organizations, and analytical services companies. They are utilized particularly by manufacturers whose products are marketed in or imported into the U.S. USP's standards are used by companies, regulatory bodies, and other stakeholder groups in more than 140 countries worldwide. With its headquarters in Rockville, MD, USP also has sites and offices in Hyder- abad, India; Shanghai, China; São Paulo, Brazil; and Basel, Switzerland. USP–NF provides comprehensive informa- tion to guide quality at all stages of biological manufacturing—from raw material qualifica- tion to the development and validation of prod- uct assays to packaging. USP's standards are critical to biopharmaceutical developers, QA/ QC scientists, analytical development scientists, QbD specialists, regulatory experts on biologics, bioassay developers, and biostatisticians. Collaborative partnerships between USP and other thought-leaders in the biologics area shape industry standards. Prospective partners 78 | October 1, 2012 | genengnews.com | Genetic Engineering & Biotechnology News are invited to submit mono- graphs and proposals to re- vise and modernize standards relevant to biologics and bio- technology; supply candidate materials for USP Reference Standards development; par- ticipate in USP workshops and stakeholder forums that help inform the standards- setting process; and recom- mend ideas for future mono- graphs, general chapters and Reference Standards. Capabilities Monographs in USP–NF include tests, procedures for those tests, and acceptance cri- teria for determining the qual- ity of a specific article of com- merce. In addition to mono- graphs for drug substances, drug products, and excipients, USP–NF includes general chapters, which are necessary to demon- strate compliance with particular monographs or provide information to help guide companies in their quality strategies. Some specific USP–NF general chapter top- ics for biologics cover the design, validation, and analysis of bioassays; quality attributes of pro- tein A; cellular and tissue-based products; gene therapy products; growth factors and cytokines; ancillary materials in cell manufacturing; and immunogenicity testing. Also included are gen- eral chapters on critical issues related to bacte- rial endotoxins; sterility testing; microbiological and bioburden control; injectibles; supply chain integrity and more. Currently USP is working vigorously to de- velop new chapters on mono- and oligossacha- ride 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 Refer- ence Standards includes insulins and other pep- tides; low molecular weight heparins; endotox- ins; 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 oligosaccha- ride mixtures. Q ADVERTORIAL