In deploying a horizontal approach to develop standards for biologics, USP's activities in the following areas are reflected
in the themes of session tracks for the Science & Standards Symposium.
USP has developed a suite of bioassay chapters that includes guidance and information focused on development, analysis, and
validation of biological assays. As a companion to these guidance chapters, USP has also developed example bioassay data sets
and will make software analyses of the data available to meeting attendees. Case studies on analytical and compliance challenges
related to bioassays as well as the assignment to biologics of quantities and values will be discussed.
Critical quality attributes for biologics
In the development of product-class standards, identification of critical quality attributes (CQAs) that apply across products
within a designated class is key. CQAs of <129> Recombinant Therapeutic Monoclonal Antibodies is one example of a USP chapter
in development which focuses on CQAs. In addition, USP <90> Fetal Bovine Serum—Quality Attributes and Functionality Tests
became official in USP-NF in May 2011.
Ancillary materials and process enzymes
Ancillary materials, including growth factors and process enzymes, are necessary for the manufacture of certain biologics,
such as vaccines and cell-based or tissue-based therapies, but generally must be removed from the final product once the manufacturing
process is complete. USP <1024> Bovine Serum addresses quality issues related to the production, sourcing and characterization
of this class of ancillary materials, with the intent of supporting its users in conducting risk assessment and implementing
The functionality of a protein-based therapy is primarily based on its proper structure as well as correct post-translational
modifications. General Chapter Glycoprotein and Glycan Analysis—General Considerations <1084> has been developed to address
modifications that result from the process of glycosylation. In addition, USP is working on two chapters addressing compendial
procedures for oligosaccharide and monosaccharide analysis, important for the manufacture of glycosylated proteins.
Analysis and regulation of bioassays
As technological improvements emerge, capabilities regarding bioassays must be updated to parallel those changes. Transitioning
legacy products away from animal-based potency assays is an important issue for manufacturers. USP guidance chapters include
USP <111> Design and Analysis of Biological Assays, which provides direction to users on developing appropriate strategies
regarding biologic potency.
The topics of the conference speak broadly to industry professionals engaged in the development, analysis and quality control
of biological medicines, as well as to professionals interested in the regulatory and compendial issues related to the latest
trends in biotechnology. In support of its nearly 200-year-old mission to advance public health, USP is committed to continuing
this global dialog among manufacturers, regulators, and practitioners to address the need for public quality standards for
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Tina Morris, PhD, is vice-president of biologics and biotechnology for the US Pharmacopeial Convention.