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Cleaning by an alternate mechanism

Cleaning by the same mechanism as elution

In between acid strip and NaOH regeneration

Cleaning by an alternate mechanism

FIGURE 16.9 Typical flowsheet for a protein A process.

foundation for generic process development of these biomolecules, which is a key strategic initiative for the biotech industry today. The yield for this process step is very high (>90%) and a high degree of purification factor (>2 logs) can easily be obtained. Several attempts have been made to purify antibodies in three chromatographic steps without recourse to a Protein A step [16,76]

but such nonaffinity purification schemes require significantly greater methods development time and resources and are potentially less robust, which is not desirable in a timeline driven development scenario. Even though Protein A chromatography is relatively straightforward to develop for laboratory-scale separations, a number of areas require special consideration and development time when production scale separations are being designed. These include stabilization of the product during low pH elution, optimization of binding capacity, and throughput, improving product purity through the development of specific wash steps and increasing resin lifetime through improved regeneration conditions.

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