Challenges Related to Extractables/ Leachables During Bioprocessing

Abstract

As the production of biologics grows, so does the need to control impurity contamination. Some compounds have the possibility to leach into the products during their manufacturing, hampering their production. The presence of these compounds in the final product may also have dangers to the end user if not removed. These compounds are either simple organic molecules or heavy metals, and are often utilized during production, or are part of the disposable plastics in the processing. Some of the organics can be broken down into toxic materials, while the metals are shown to lead to undesirable effects at higher concentrations. Hence, monitoring their presence and concentrations in the final product is necessary for bioproduction efficiency and ultimately patient safety. This review discusses the most common organic and metallic extractables/leachables found in plastics that are utilized in the synthesis of biologics.