Monoclonal antibodies have become the single most important product class in the area of modern recombinant therapeutics. As they mature as marketed products and many of the innovator products are reaching the end of their patent horizon, the consideration of public standards for these products becomes more important than ever in anticipation of a dynamic global multi-manufacturer market. These standards will be critical in assuring quality across manufacturers and products. Just as global manufacturers are taking advantage of platform technologies for the manufacturing and analytical characterization of these structurally highly similar molecules, procedural standards for the analysis of MAbs can be an important tool for the creation of consistent analytical expectations and sound technical approaches. USP has developed a General Chapter  that collects several of the most critical analytical procedures for MAbs and will be supported by a USP System Suitability Standard. This presentation will detail the extensive round robin testing that was done in support of the Chapter development in order to assure that procedures and proposed system suitability criteria are valid and widely applicable to MAbs manufactured around the world.

USP chapter analytical procedures for recombinant therapeutic monoclonal antibodies

248th National Meeting (2014)

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