Analysis of Impurities and Contaminants in Biotech or Biological Products

As outlined in the ICH Q6B guidelines, the analysis of product-related and process-related impurities and contaminants in biotech or biological products is a critical aspect during product characterisation. Typically, impurities and contaminants may consist of the following:

  • Process-related impurities: Impurities deriving from manufacturing processes (e.g. antibiotics, media components, host cell proteins, leachables, residual solvents, detergents).
  • Product-related impurities: Molecular variants of the desired product possessing properties not comparable to the desired product (e.g. truncated, modified and/or aggregates of the desired product).
  • Product-related substances: Molecular variants of the desired product with comparable properties to the desired product which have no deleterious effect on safety and efficacy of the drug product.

At SGS M-Scan, we offer a number of services and techniques that may be applied for the characterisation of these groups of impurities and contaminants.