Bioprocessing introduces a wide array of impurities, each with the potential to impact product safety, stability, or efficacy. Whether originating upstream during cell culture and growth, downstream during purification, or from equipment and single-use systems, these residuals must be precisely quantified to comply with regulatory expectations.

We understand just how crucial accurate impurity profiling is to process validation. Scientists working at Eurofins BioPharma Product Testing (BPT) network of laboratories have developed and qualified thousands of robust, reliable methods engineered to detect and measure process-related impurities at the low concentrations typical in complex biologics matrices.

Meeting regulatory expectations means being able to both identify impurities and remove them. That’s why Eurofins BPT offers comprehensive impurity testing solutions for every stage of your process. We combine advanced analytical technologies with deep scientific expertise to deliver the vital data and documentation you need.

Our laboratories are equipped with the latest in chromatographic, mass spectrometric, and molecular technologies to ensure high sensitivity and specificity—crucial for detecting trace impurities in biologics.

Working with Eurofins BPT means you will be working with a partner who understands the science and the regulatory landscape. We are here to help you navigate the complexity of bioprocess validation with confidence, accuracy, and speed.