Residual Solvent Testing

A variety of compounds added during the manufacture of your biopharmaceutical products can appear in the final product as process-related impurities. However, residual impurities can be difficult to detect. That’s why we offer you effective process related impurities analysis, residual impurity testing and residual analysis in biopharmaceuticals. As a result, we can help you to confirm the efficient removal of impurities by the downstream process and absence from the final product.

Why choose process-related impurities and residual analysis from SGS?

We offer process-related impurities analysis, residual impurity testing and residual analysis in biopharmaceuticals to help you:

• Analyze process-related impurities and contaminants in your biotech or biological products
• Confirm the efficient removal of impurities by the downstream process
• Ensure the absence of impurities from your final product
• Detect host cell impurities, including host cell proteins and host cell Deoxyribonucleic acid (DNA)
• Develop specific host cell protein assays for your expression cell line
• Demonstrate safety by showing whether host cell impurities fall within acceptable levels

Trusted Process-related Impurities Analysis From a Leading Provider

As the world’s leading provider of residual impurity testing and residual analysis in biopharmaceuticals, we provide you with the experience, technical and regulatory expertise, and unique global network you need.

We offer you a wide range of state-of-the-art chromatography and mass spectrometry instrumentation, together with extensive method development experience, which are utilized in the optimization of the analytical method for the analysis of impurities. The optimized method can then be validated either as a limit test or full ICH Q2(R1) validation performed under GMP.

To find out more about our process related impurities analysis services, contact us today.