Impurities in biopharmaceutical products (also known as residuals) can be either process or product related. Process-related impurities are derived from the manufacturing process, for example cell culture, downstream or cell substrates, while product-related impurities are non-active molecular variants of the biologic, and are formed during expression, manufacture or storage. Understanding these impurities is an essential first step in developing control strategies to reduce or remove them from your final product.

Identification and quantification of process and product related impurities

RSSL offers a comprehensive range of analytical services around the identification and quantification of impurities as required in both the ICH Q6B and EMA guidelines. These methods can be validated according to your requirements and applied in process validation or product release.

Our analytical solutions to monitor process-related impurities in your biopharmaceutical product include:

  • Cell culture reagents
    • Antifoams
    • Growth Modifiers (Insulin)
    • Antibiotics
    • Protein A
    • Solubilisers
    • Residual solvents
    • Chelating agents
    • Extractables and leachables

Our experts are specialists in cell derived impurities, i.e. host cell DNA and host cell protein. We are able to set up and establish programs of work to monitor the following product-related impurities:

Our analytical services are available to GMP and can be validated in accordance with ICH guidelines.  They can be applied to either process validation or testing of batches of drug product or drug substance.

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