BIOT 471 |
| Protein A chromatography has been used as a capture step in most antibody and Fc-fusion purification processes. The step concentrates the product, removes host cell protein and media derived impurities, and provides a product pool with an appropriate ionic strength, pH, and buffer for the following step. The step often suffers from precipitation, the level of which depends upon the strength and type of wash, the ionic strength of the elution buffer, the pH of neutralized peak, and the buffer used in elution and neutralization. A high throughput Protein A screen has been developed that quickly identifies acceptable operating conditions within a large experimental space. The screen evaluates 288 combinations of wash conditions, elution conditions, and neutralization conditions to allow facile optimization of the step in column mode. The screen has been an important factor that allows Phase I/II development of the Protein A step with a small number of lab-scale chromatographic runs. |
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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 |