Cost-effective Process Development and Equipment Design for Industrial Chromatography

Abstract

Over the last 20 years, liquid chromatography has evolved into an invaluable tool in downstream processing in manufacturing of many biopharmaceuticals. Today, with the availability of high purity wide pore silicas, which are capable of withstanding high operational pressures, chromatographic separations of peptides, proteins and nucleic acid components are commonplace. However, purification costs can dominate the total production costs of a biopharmaceutical process; therefore in order to obtain an economic purification process significant method development is required. Practical issues which are important for cost-effective process development and equipment design will be presented and discussed.

References
1. Hovgaard L., Sriver L., Frokjaer S. // Pharmaceutical Formulation Development of Peptides and Proteins, Protein Purification, CRC Press. 1999. P.29 - 38.
2. Dauwe C., White C.A. // Биофармацевтический журнал. 2009. Т.1. С.3-8.
3. Mann G. // Analysis. 1998. V.26(7). P.M76 - M82
4. Morishita K., Yamada Y., Omote M.,  Kuriyama N. // Development of an effective purification method for peptides and proteins using silica gel based reversed phase packing material. European Peptide Symposium, Gdansk, Poland. 5th September 2006.
5. Kuriyama N., Shoji N., Taniguchi K., Omote M., Moriyama M. // Optimisation of the effective separations for peptides and proteins using highly durable packing materials for high performance liquid chromatography. Pittsburgh Conference. 28th February - 4th March. 2005.