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Characterizing Biotherapeutics with HPLC

Smart Solutions for large Molecules

24-11-2010

As demonstrated here, there are a broad range of HPLC applications used in development, production, validation and release of protein therapeutics for human use. Some of the applications mentioned above are mandatory when submitting a new biopharmaceutical to approval at the regulatory agencies. The introduction of the first so-called biosimilars in Europe further increased the demand for highly efficient analysis methods. The continuous development of new stationary phases for the common modes of biochromatography, such as size exclusion, ion exchange and hydrophilic interaction chromatography support biochemists in increasing lab productivity and establishing high-throughput HPLC analysis not only for small molecules but also for large biopolymers...

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