Chromatographic HTS and simulation for improved process development and optimization

BIOT 307

Matthias Bensch1, Jacob Nielsen2, Janus Krarup2, Thomas Budde Hansen, tmhs@novonordisk.com3, Steffen Kidal, sffk@novonordisk.com4, Arne Stabe2, Jürgen Hubbuch1, Ernst Hansen5, and Lars Sejergaard6. (1) Institute of Biotechnology 2, Research Center Jülich, Jülich 52425, Julich, Germany, (2) Protein Separation, Novo Nordisk A/S, Hagedornsvej 1, DK-2820, Gentofte, Denmark, (3) Department of Protein Separation, Novo Nordisk A/S, Hagedornsvej 1, Gentofte, DK-2820, Denmark, (4) HAD1.175, Ge, Novo Nordisk A/S, Hagedornsvej 1, DK-2820 Gentofte, Denmark, (5) Protein Separation, CMC API Production, Novo Nordisk A/S, Hagedornsvej 1, DK-2820 Gentofte, Denmark, (6) Novo Nordisk, Denmark
Increased demand of material for clinical trials and handling of an increasing number of projects in the biopharmaceutical industry are calling for different ways of performing process development. This paper will present true examples of implementation of high-throughput screening techniques as stand alone tool and in combination with mathematical modelling for separation development, trouble shooting, and batch release for chromatographic purification steps. Further, these techniques will be discussed in relation to scale-up, general accuracy of results, and PAT.
 

Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster

Division of Biochemical Technology

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007