Bioanalysis Zone

The challenges of product- and process-related impurities to an evolving biopharmaceutical industry

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“The analytical technologies available for the monitoring of product- and process-related impurities in recombinant protein preparations have developed enormously in the last 10–20 years. However, these have not yet been fully harnessed to generate a complete picture of the mechanisms determining process and product impurities.”

Biopharmaceutical products are synthesized by living cells, and hence during the purification process the substrates for growth, host cell components and product variants must be removed. These impurities are classified as:

  • Product-related impurities: variants that differ from the desired product;
  • Process-related impurities: materials added to the process and cellular components;
  • Contaminants: species that should not be present in the raw materials or manufacturing process, for example, microbes.
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