Chromatographic HTS and simulation for improved process development and optimization

BIOT 467

Arne Staby, ast@novonordisk.com1, Matthias Bensch2, Jacob Nielsen1, Janus C. Krarup, jkup@novonordisk.com1, Thomas Budde Hansen, tmhs@novonordisk.com3, Steffen Kidal, sffk@novonordisk.com4, Lars Sejergaard5, Ernst Hansen6, and Jürgen Hubbuch2. (1) Protein Separation, Novo Nordisk A/S, Hagedornsvej 1, DK-2820, Gentofte, Denmark, (2) Institute of Biotechnology 2, Research Center Jülich, Jülich 52425, Julich, Germany, (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) Novo Nordisk, Denmark, (6) Protein Separation, CMC API Production, Novo Nordisk A/S, Hagedornsvej 1, DK-2820 Gentofte, 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.
 

Downstream Processing: High Throughput Screening in Process Development
2:00 PM-4:20 PM, Thursday, August 23, 2007 BCEC -- 107B, Oral

Division of Biochemical Technology

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