Why is there a need for new standards in this area, and what role is USP playing in the development of these new standards?
Dr. Kibbey: While many unique methods for measuring residual HCP and DNA have been developed and validated, companies still struggle with appropriate development and validation of assays that are suitable and will meet regulatory requirements.
The standards-setting work of the United States Pharmacopeial Convention (USP) can provide industry with best practices or validated procedures that enable companies to develop their own assays, or, in the latter case, verify that the USP procedure is suitable for their purpose. Through the efforts of its expert committees and expert panels, USP develops standards for the identity, strength, quality and purity of medicines and their ingredients, and for the identification of impurities.
USP’s documentary standards are published as monographs, general chapters, or General Notices in USP’s compendia—United States Pharmacopeia and the National Formulary (USP–NF). USP also develops Reference Standards—chemical and biologic materials—used by manufacturers to evaluate their own products against tests and procedures included in USP’s standards.
Currently, USP has an expert panel charged with making recommendations for a new general chapter numbered below 1000 that will include a validated test and associated reference standards for quantitation of residual E. coli and CHO genomic DNA in recombinant biotherapeutics. This proposed general chapter will be published in 2014 in Pharmacopeial Forum (PF), USP’s online, free-access journal for receiving comments on proposed or revised standards.
Another expert panel is developing a new informational general chapter (numbered above 1000) containing best practices for development and validation of residual HCP procedures. Unlike general chapters designated below 1000, those above 1000 do not include specific tests, system suitability criteria, or acceptance criteria.
As standards for residual impurities in biotech products are developed, USP will continue to solicit input from a wide range of stakeholders. This is accomplished through publication in PF of developing standards (where stakeholders may comment), as well as public meetings where industry and regulatory stakeholders have an opportunity to share their perspectives with USP.
On June 3–4, 2013, USP and the Biopharmaceutical Emerging Best Practices Association (BEBPA) will co-host a workshop entitled, “Measurement of Residual Host Cell Protein and DNA in Biotechnology Products.” The workshop will feature discussions on platform approaches for measurement of residual host-cell proteins; reagent quality issues for residual impurity assays; emerging technologies and best practices for measurement of host-cell proteins; and U.S. and European regulatory perspectives regarding these process-related impurities.
The workshop will also highlight USP’s ongoing work related to standards for residual host-cell impurities. Information on the workshop may be accessed at: http://uspgo.to/host-cell-protein.
Also, be sure to check out the below video from USP, entitled "USP Workshop: Residual Host Cell Protein & DNA in Biotechnology Products":