Prospect of plant based production methodologies for Trastuzumab (Herceptin)

8th October 2013

Category: Biosimilars

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By: Dr Daniel Galbraith, CSO,

The production of Biosimilar Monoclonal Antibodies often follows the same or similar production methodologies to the innovator product, Chinese Hamster Ovary Cells being the most common method. However there is nothing in the current guidelines to prevent the use of other production systems for these products. In the paper published by Grohs et al., 2010 they used a plant related to Tobacco to produce Trastuzumab (Herceptin). The Herceptin produced was tested in functional assays and compared to the Herceptin produced by Genentech/Roche and was found to have a similar mechanism of action. Even though this study was not intended to be used as a means of producing Biosimilars, it does raise the prospect of using low cost production systems to produce product which would be too expensive, in some markets, to produce by traditional means. Many of the biological functions of Monoclonal Antibodies require specific glycosylation to be fully functional; this is something the production systems have to take into account.

Click here to view article by Grohs et al.