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MAb chapter <129> is one of a series that USP will be developing on quality attributes for different types of biologic/biotech products, including enzymes, vaccines and peptides. The development of the quality attribute chapters including <129> is called for in the work plan for the current USP five-year cycle (2010-2015). The effort on <1260> continues an initiative begun under the previous cycle.
The subcommittee on general chapter <1260> – an overarching chapter that provides general guidance about various aspects of MAb structure and function – is being chaired by OncoMed Process Development VP Michael Mulkerrin, who also chairs the Biologics and Biotechnology Expert Committee.
The chapter will provide manufacturers with guidance on: ● how to develop a monoclonal antibody ● what critical information is needed to define quality attributes ● how to create expression vectors and manufacturing processes that are associated with the downstream purification, formulation and filling of those products, and ● attributes of the facilities that MAbs are made in. Other sections will deal with monoclonal regulatory and post-approval issues.
Genentech Technical Regulatory Policy and Strategy Director Earl Dye provided an update on the USP MAb effort at the RAPS annual meeting in Indianapolis, Indiana in late October, referencing a report by Mire-Sluis at the USP Science and Standards Symposium in Seattle, Washington a few weeks earlier.