Monitoring impurities in biopharmaceuticals produced by recombinant technology

The unique nature of recombinant technology and the biotherapeutic production process means that regulatory agencies around the world not only require extensive characterization of the product, but they have also provided 'guidelines' to control and monitor product- and process-derived impurities and contaminants. Not only might these impurities and contaminants have a profound effect on product quality and efficacy, but they might also introduce unwanted and unknown side effects, even in trace amounts. The authors present a comprehensive understanding of the nature of possible product- and process-related impurities, and also describe current and future methodologies to control and monitor these impurities.