Scale-up Chromatography Technology

Chromatography is a well-established biopurification method. Processing biomolecules for initial capture of target product, purification of the target molecule and the removal of potentially harmful contaminants from the purified product, all place different demands on the chromatography process. Choosing the right Chromatography Technology No single technology can address all of your processing needs. Pall offers chromatography-users a variety of chromatography process options to optimize separation efficiency for your process economics. Our product range includes chromatography sorbents, Mustang® membrane technology, columns and systems. The first question to answer when designing a process is the correct choice of chromatography media. The chart below highlights the main points to consider: Ion-exchange Chromatography Since ion-exchange is the most widely used chromatographic technique, guidelines on how to determine the most suitable ion-exchange chromatography chemistry for a given application are provided below.

Process Optimization and Simple Scale-up Guidelines

There are several key parameters that will influence the ability of chromatography media to capture, separate or purify the target molecule. These include:

• Process variables, pH being the most important parameter
• The ionic strength of the mobile phase also plays a key role in determining the efficiency of binding and elution of the target species In order to design the optimum process for large scale manufacturing, small scale scouting studies are required to:
• Maximize the separation of impurities from the target molecule
• Determine the maximum amount of product that can be loaded before the purity specification is no longer met for each chromatographic step. After chromatographic conditions have been optimized, the following issues should be be considered before scale-up:
• Increase chromatographic media volume in proportion to increases in sample volume
• Maintain the sample and mobile phase composition
• Hold the total elution time constant in proportion to media volumes
• Maintain linear flow rates to ensure gradients are accurately replicated with increased scale