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Trends and issues in biopharmaceutical development

A Closer Look at the Capacity Glut

Most recent analyses of the supply and demand for mammalian cell culture manufacturing capacity confirm a global excess. However, with only ten companies controlling almost 80% of this capacity, the apparent glut may not be as large as it seems. If we look separately at those companies with manufacturing capacity...

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EMA Tackles Biosimilar MAbs

Following its trail-blazing issuance of guidelines for the approval of biosimilar well-characterized molecules such as insulin and human growth hormone, the EMA recently issued a draft guideline on biosimilar medicines containing monoclonal antibodies (MAbs).   Considering the complexity of MAbs, this brave step forward in the regulation of biosimilars is a welcome...

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