Downstream Processing

6.

Stage 5: Final Purification and Polishing

6.1.

Polishing Chromatography

6.1.1.

Objectives of Polishing Steps

6.1.2.

Size-Exclusion Chromatography

6.1.3.

Ion-Exchange Polishing

6.1.4.

Hydrophobic Interaction Polishing

6.2.

Non-Chromatographic Purification

6.2.1.

Crystallization

6.2.1.1.

Principles of Protein Crystallization

6.2.1.2.

Crystallization Conditions

6.2.1.3.

Process Parameters

6.2.1.4.

Scale-up Considerations

6.2.2.

Preparative Electrophoresis

6.2.2.1.

Principles of Electrophoretic Separation

6.2.2.2.

Equipment Types

6.2.2.3.

Applications in Purification

6.3.

Viral Inactivation and Removal

6.3.1.

Viral Inactivation Methods

6.3.1.1.

Low pH Treatment

6.3.1.2.

Solvent-Detergent Treatment

6.3.1.3.

6.3.2.

Viral Filtration

6.3.2.1.

Parvovirus Filters

6.3.2.2.

Filter Validation

6.3.2.3.

Process Integration

6.4.

Impurity Removal Strategies

6.4.1.

Host Cell Protein Removal

6.4.2.

6.4.3.

Endotoxin Removal

6.4.4.

Aggregate Removal

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5. Stage 4: Purification by Chromatography

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7. Stage 6: Formulation and Final Processing