Health risk assessment of several vaccine impurities


A global biotherapeutics pharmaceutical company


Several degradants had been identified and quantified in a vaccine product, and the client required an independent assessment of the potential health risks to patients that these impurities might pose following vaccination.

Project goals

To provide the client with a high-quality hazard (toxicity) and health risk assessment on the impurities, taking into account the dosing route and anticipated treatment frequency and duration.


Patient exposures were estimated and health risk assessments were carried out for each degradant. Threshold and non-threshold toxicity endpoints were covered. The assessment made use of substance-specific toxicity information and data on structurally-related analogues. Where such data were not identified, use was made of the Threshold of Toxicological Concern (TTC) concept, in combination with guidance from EMA, ICH and PQRI. Bibra was able to demonstrate convincingly that the exposures would not pose any significant health risks to patients.

Bibra project leader

Pete Watts

Pharmaceutical Product Toxicological Support

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