ICH Q6B sets out the guidelines for the characterisation of biopharmaceuticals, which includes structural characterisation,  physicochemical properties, biochemical assays, and product and process related impurities of the desired product. The complexity of proteins means that a number of techniques must be used in order to characterise them fully.

Therefore specifications should focus on those molecular and biological characteristics found to be useful in ensuring the safety and efficacy of the product.

RSSL’s protein characterisation services support you in ensuring the identity, purity, stability and activity of your biopharmaceutical, with all work performed to GMP as required.

We can support you with: 

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