HPLC Method Development Software for the Pharmaceutical Industry

Computer Assisted Liquid Chromatographic Method Development for the Separation of Therapeutic Proteins


While most traditional pharmaceuticals represent chemically synthesised small-molecular weight molecules, the number of biopharmaceuticals that enter the market today is rapidly increasing.

Particularly, recombinant monoclonal antibodies (mAbs) are delivering interesting results in the treatment of autoimmune, cardiovascular, and infectious diseases, as well as cancer and inflammation.

Benefits for the patients of these large biomolecules include high-efficacy, specificity, wide therapeutic range, and limited side effects. Moreover, generic biologics or "bio-similars" are entering the market, as the patents of the oldest approved biopharmaceuticals have expired.

A thorough drug characterisation is required by regulatory bodies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA), because the variability in the production of these biopharmaceuticals is typically greater than for conventional pharmaceuticals. To fully describe these complex samples, a variety of orthogonal methods is usually required.

Spectrophotometry, electrophoresis, chromatography and mass spectrometry represent the most relevant techniques.

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