The main reason is product consistency. Protein A affinity columns have been around for quite a while. They are well developed, reliable and used by a vast majority of biotech and pharma companies for antibody purification. From one batch to another, the antibody quality will remain the same. On the other hand, HCP affinity columns are very often custom-built and simply not as robust. Over time, HCP affinity columns tend to deteriorate leading to poorer antibody quality. In picking protein A affinity columns over HCP affinity columns, we sacrifice sensitivity. However, the FDA considers acceptable any biologics with HCP levels between 1 and 100ppm. The limit of sensitivity of our kit is 2.5ppm (based on using the 10ng/ml data point from the standard curve and spike in 4mg/ml of drug substance), which is adequate to meet any regulatory requirement for HCP analysis.
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