Impurities in biopharmaceutical products (also known as residuals) can be either process or product related. Understanding these impurities is an essential first step in developing control strategies to reduce or remove them from your final product.
We offer a range of analytical solutions to monitor impurities in your biopharmaceutical products, as required in both the ICH Q6B and EMA guidelines. All our methods can be validated according to your specific project requirements and applied in process validation or testing of drug product or drug substance batches. These services are available to GMP standard and can be validated in accordance with ICH guidelines.
Our analytical solutions to monitor process-related impurities in biopharmaceutical products include:
At RSSL, our scientists are experts in the identification of cell-derived impurities, such as host cell DNA and host cell proteins. Using this knowledge, we are able to establish programs of work to monitor the following product related impurities: