Хроматографические процессы и оборудование для производства биофармацевтических препаратов (на английском языке)

Downstream processing in manufacturing of biopharmaceuticals is typically a multi-step purification using chromatographic separation techniques. Most commonly used chromatographic techniques such as ion exchange chromatography, size exclusion chromatography, normal and reversed phase chromatography are outlined in this article. Reversed phase HPLC, currently used both for analytical as well as for preparative purposes, is described with focus to the generally used media, systems and hardware. References Bairamashvili D.I. , Rabinovich M.L. // Biotechnol.J. 2007. V.2 (7). P.801-817. Crommelin D. J. A., Sindelar R. D., Meibohm B.  // Pharmaceutical Biotechnology: Fundamentals and Applications, Informa Healthcare (1st Ed.). 2007. P.496. Walsh G. // Pharmaceutical Biotechnology: Concepts and Applications, Wiley & Sons (1st Ed.). 2007. P.498. Janson J.-C. , Ryden L.  // Protein Purification: Principles, High Resolution Methods and Applications, Wiley VCH (2nd Ed.). 1998. P.712. Hagel L. , Jagschie G. S , Sofer G. // Handbook of Process Chromatography: Development, Manufacturing, Validation and Economics, Academic Press (2nd Ed.). 2007. P.384. Peterson E.A., Sober H.A. // J.Amer.Chem.Soc. 1956. V.78. P.751-755. Porath J., Flodin P. // Nature. 1959. V.183. P.1657-1659. Hancock W. S. // Handbook for the separation of amino acids, peptides and proteins, CRC Press. 1984. Kroeff E . P ., Owens R . A ., Campbell E . L ., Johanson R . D ., Marks H . I . // J.Chromatogr. 1989. V.461. P.45-61.