Journal of Chromatography & Separation Techniques
Open Access
ISSN: 2157-7064
+44 1300 500008
ISSN: 2157-7064
+44 1300 500008
Fabian Holenstein, Christer Eriksson, Ioana Erlandsson, Jill Simon, Lars Erni, Katharina Stein, Michael Glaettli, Andres Tschupp, Adriana Milicov, Patrick Schindler, Thomas Pietzonka, Johanna Koelln and Jean-Marc Schlaeppi
Novartis Institutes for Biomedical Research, Switzerland
GE Healthcare Life Sciences, Sweden
GE-Europe Glattbrugg, Switzerland
Scientific Tracks Abstracts: J Chromatogr Sep Tech
Therapeutic antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving platforms for the preparation and analysis of early candidates for faster and better antibody selection and characterization. We report a new integrated platform for unattended harvesting and 2-step purification of antibodies expressed transiently in HEK293T-cells at the 1-liter scale. The system consists of two bench-top preparative chromatography instruments connected to a central unit with eight disposable filtrations devices used for loading and filtering the crude biomass feeds. Our end-product QC analysis demonstrates that the quality of the material prepared by the 2-step automated purification is fully comparable to the material purified by standard manual 2-step purification. Average recoveries were also comparable to those obtained by manual purification, indicating that this automated system allows the cost-efficient preparation of therapeutic antibodies in the 20-200 mg range, and covers the requirements for early in vitro and in vivo profiling of drug candidates.
Fabian Holenstein holds an Engineering degree in Biotechnology and a Master’s in Pharmaceutical Biotechnology. He works as a Senior Scientist in the section of protein production and antibodies at Novartis Institute for Biomedical Research in Basel/Switzerland.