Developing an International Dialogue on Biologics Standards - US Pharmacopeia promotes horizontal standards and a product-class approach for quality attributes. - BioPharm International


Developing an International Dialogue on Biologics Standards
US Pharmacopeia promotes horizontal standards and a product-class approach for quality attributes.

BioPharm International
Volume 24, Issue 7, pp. 61-62


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 risk-mitigation measures.

Post-translational modifications

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 biologic medicines.

Register for the event

Tina Morris, PhD, is vice-president of biologics and biotechnology for the US Pharmacopeial Convention.

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