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![]() The majority of purification processes for mAbs involve Protein A-based chromatography, which results in a high degree of purity and recovery in a single step. Chromatography exploits the physical and chemical differences between biomolecules for separation. In the biopharmaceutical industry, chromatography is a critical and widely used separation and purification technology due to its high resolution. This is generally accomplished through use of centrifugation, depth filtration and sterile filtration, although other approaches may be applicable depending on scale and facility capability. The first step in the recovery of an antibody from a mammalian cell culture is harvest-removal of cells and cell debris to yield a clarified, filtered fluid suitable for chromatography, i.e., the harvested cell culture fluid (HCCF). These include leached Protein A, extractables from resins and filters, process buffers and agents such as detergents that may have been employed for virus reduction. In addition, impurities introduced during the purification process must be removed as well. Impurities such as host cell protein, DNA, adventitious and endogenous viruses, endotoxin, aggregates and other species must be removed while an acceptable yield is maintained. The purification process needs to reliably and predictably produce product suitable for use in humans. This allows similar purification processes to be employed in the recovery of different products, establishing a platform process that can be used to purify similar molecules with minimal process alterations. These molecules are often derived from a common framework, and have a high degree of homology, and therefore they have similar physico-chemical properties. 1 With the prominence of mAbs as therapeutic agents, many companies have multiple antibodies in their development pipeline. Hundreds of monoclonal antibodies (mAbs) are either currently on the market or under development. ![]()
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