IONIC EXCHANGE CHROMATOGRAPHY This is a form of affinity chromatography that allows for the separation of product and contaminants through the use of specific electrical charges produced by the individual molecules. Resins are applied to depending on the compound one wishes to remove ie if your compound is negatively or positively charged. This system is specifically used after one of the three previously stated methods of separation and an ultrafiltration/diafiltrtion step as it is costly and therefore is not viable for use with large volumes of compound. It is mainly used for the removal of any remaining components from the media and including cell fragments, chemical agents and lipid components. (Duong et al 2014) Ionic exchange resin use …show more content…
They are capable of surviving an array of intense environmental conditions and can even be known to survive lyophilzation processes. There are two main kinds of viral agents that will infect a product flow i.e. cell line derived and externally introduced. Cell line derived viral agents are as the name suggest are sourced from the production cell line uses as the product synthesizers. These viruses can be adhered to the surface of the cells or more commonly are genetically encoded within the cell line. Once the cells have been upscaled and are provided with a variety of nutrient they will replicate the protein and likely expose it to the product and media components allowing for infection of patients. . Externally derived viruses are the ones introduced by external sources. This can come directly from media itself due to infected batches or from process workers not adhering to correct aseptic protocol as well as improper cleaning of equipment. Regardless of source viral agents are incredibly dangerous especially to those of already compromised immunity such as those to which our product is targeted. Therefore it is of the utmost importance that viral agents are removed and or inactivated in process to prevent such patient