The journey of a drug to market begins with a molecule which is showing potential to treat, cure or prevent disease. There are many steps along this journey; one of the most important steps is the need to separate and purify the molecule from a complex feed stream. Chromatography is the answer to getting high-purity products, especially with proteins. Chromatography is still the major tool on all levels of the DSP from the first capture to the final polishing step.
There are many methods of executing the chromatography step. These are the most used methods:
- Ion exchange chromatography (IEX) – is the most popular method for the purification of proteins and other charged molecules. Positively charged molecules are attracted to negatively charged solid molecules.
- Hydrophobic interaction chromatography (HIC) – separates protein molecules using the properties of hydrophobicity. In this method, proteins containing both hydrophilic and hydrophobic regions are applied to a HIC column under high salt buffer conditions. Due to these salt buffer conditions; proteins of the hydrophobic area can precipitate out of the solution.
- Affinity chromatography (AC) – can be used to purify and concentrate a substance from a mixture to a buffering solution, or it can be used to reduce the number of unwanted substances and to identify the biological compound of a particular substance.
- Gel filtration chromatography (GFC) – separates proteins and peptides based on size. Molecules will move through greater or smaller porous membranes by diffusing.
Assemblies for chromatography
- Tubing assemblies are designed to standardize the chromatography process. They can include several single-use sensors to measure the parameters of the fluid.
- Platinum-cured silicone tubing.
- Platinum cured silicone pump grade tubing can be used in peristaltic pumps to transport the fluid to the column.
- Biopharmaceutical grade TPE tubing.
- Single-use bioprocess bags are available up to 2000L and are designed the for preparation, storage and transport of biopharmaceutical solutions.
- 2D Rocker bags for cell culture applications.
- Cryo bags are available for up to 20L to store the biopharmaceutical products at -85°C.
- Sampling bottle systems are available from 60mL. The bottles are designed to take sterile samples of the product to check the quality.
- Sampling bag system from 50ml. The bags are designed to take sterile samples of the product to check the quality.
- Filters for column guard filtration can be used to remove particulates from the flow stream.
- The use system with magnetically levitated bearing less motor technology can be very useful for transporting fluids into the chromatography column.
Plastic fittings & connectors
- Sterile connectors are an alternative to welding and sealing.
- Pinch valves can be used to shut off some of the fluid paths.
- Fluid management solutions in single-use systems. It can be used to modulate and control flow automatically. It also can be implemented in the customized single-use assemblies for all methods of Chromatography.
- Inline single use to monitor the pressure, flow, conductivity, pH, Temperature, and turbidity. These parameters will be measured in most chromatography methods.
- Welders to connect TPE tubing by welding.
- Sealers to seal TPE tubing by sealing.