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Most products in a biotechnology facility are proteins, which are heat sensitive. In order to minimize potential product problems, and minimize product bioburden, purification operations are carried out at 4 to 8°C. These temperatures are achieved by processing in cold rooms or in jacketed vessels.
Purification operations often involve concentrating the product as well as purifying it. Concentration is most easily achieved via high pressure ultrafiltration (UF), which can result in a 10X concentration with very little loss of product. Other common purification steps involve pH adjustment and buffer exchange through diafiltration. Microfiltration (MF), UF, and diafiltration are generally used as preparatory steps for column chromatography. Column chromatography, whether via size exclusion, ion-exchange, or affinity methods pull the product out of solution and bind it to the column resin. The bulk product can then be eluted off the column into appropriate containers to await final formulation and finishing.
There are several considerations for the proper design of a purification system:
- Design for sterile and pyrogen free product
- Sanitary design of equipment and piping
- Classified rooms
- Heat and shear sensitivity of product requiring 4ºC rooms and low shear pumps and agitators
- Support systems: WFI, buffer solutions, CIP
- Chromatography column design
Parsons' staff has experience in the design and installation of many different types of purification systems to include:
- Ultrafiltration, microfiltration, and diafiltration
- Gel filtration chromatography (based on size)
- Ion exchange chromatography (based on charge)
- Affinity chromatography (based on affinity or "lock and key")
- Hydrophobic chromatography (based on hydrophobic nature)
- Sterile filtration to obtain sterile bulk product
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