Monitoring impurities in biopharmaceuticals produced by recombinant technology

The unique nature of recombinant: technology and the biotherapeutic product ion process means that regulatory agencies around the world not only requir e extensive characterization of the product, but they have also provided 'g uidelines' to control and monitor product- and process-derived impurities a nd contaminants, Not only might these impurities and contaminants have a pr ofound effect on product quality and efficacy, but they might also introduc e unwanted and unknown side effects, even in trace amounts. The authors pre sent a comprehensive understanding of the nature of possible product- and p rocess-related impurities, and also describe current and future methodologi es to control and monitor these impurities.