Scalable Process Chromatography Across the Entire Drug Lifecycle

In biopharmaceutical manufacturing, process chromatography is a key technique used for the purification of biomolecules such as mAbs, vaccines, nucleic acids, and polypeptides. It employs chromatographic methods to separate these target molecules from complex mixtures, including contaminants generated during cell culture. 

The mixture passes through a stationary phase, such as a resin bed, membrane, or monolith. Different components interact differently with the stationary phase, leading to their separation based on properties such as size, charge, hydrophobicity, or other characteristics. A downstream process typically includes one or more chromatographic steps. 

Process chromatography is essential to producing high-purity biopharmaceuticals and represents a critical step in ensuring product quality and patient safety.

1. Affinity Chromatography: Leverages specific binding interactions between a molecule and a ligand (e.g., antigen-antibody, enzyme-substrate) to selectively separate the target molecule from contaminants. It is highly selective and often used for purifying proteins and antibodies.
2. Ion Exchange Chromatography: Separates molecules based on charge by using positively or negatively charged stationary phases. It is widely used in intermediate polishing steps of therapeutic proteins and for the purification of nucleic acids.
3. Hydrophobic Interaction Chromatography (HIC): Separates molecules based on hydrophobicity. It is often used to purify proteins and peptides with strong hydrophobic regions.
4. Mixed-Mode Chromatography: Combines different separation principles, such as ion exchange and hydrophobic interactions, to achieve improved selectivity and purification. It is used for complex biomolecule purification.

Other types of chromatography, such as size-exclusion or reverse-phase chromatography, are used less frequently in bioprocessing.

Both process chromatography and analytical chromatography use chromatographic techniques to separate biomolecules, but they serve different purposes and are used in different contexts: 

• Process Chromatography is primarily used for bulk purification of biomolecules, handling larger volumes of material. These unit operations focus on separation, producing purified product ready for further processing.
• Analytical Chromatography is used to analyze the composition of a sample, identifying and quantifying the components present. It operates at a much smaller scale, with a focus on precisely detecting and measuring the components of a mixture, typically for research or quality control purposes.

Continuous chromatography is aspecific separation technique, while 공정 집적화 is a broader concept that encompasses various strategies to improve the efficiency and sustainability of bioprocesses.