Characterization of Biologics >> Physico-chemical and Biochemical characterization >> Product related Substances

Product related Substances

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Product Related Substances are defined in ICH-Q6B as “are molecular variants with properties different from those of the desired product formed during manufacture and/or storage”. The forms that Product Related Substances take for biologicals span at least as wide as the Active Substances or principles themselves. By using sensitive equipment, and the combined minds of customer and experienced CRO scientists, many fully qualified tests have been developed, and brought to routine testing.

Product Related Impurities

  • Host cell derived DNA or proteins
  • Isoforms, variants, PTMs
  • Degradants
  • Aggregates

An extensive range of instrumentation has been applied, time and time again, for the most challenging impurity characterization in the most difficult matrices. And for easy projects too!

Feel free to challenge us, and use our experience to your benefit.

Why choose Eurofins BioPharma Product Testing NL

  • Single point of contact within our organization
  • If you have a short-term or infrequent need for testing, our self-validating method approach for residual solvents testing is a faster and more cost-effective option.