Advances in monoclonal antibodies and biotherapeutics are generating a wider range of biomolecules. However, with this molecular diversity, unique separation and purification challenges arise that are often difficult to overcome. Typical impurities include nucleic acids (DNA, RNA), host cell proteins, aggregates and glycosylation and charge variants, as well as potential viral contamination. These impurities can prove problematic to separate but need to be cleared to acceptable levels in accordance with guidelines established by regulatory agencies.
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