Development of permissible daily exposure levels of impurities present in pharmaceutical products

ToxMinds is a key resource to a major multinational biopharmaceutical company on the safety assessment of extractables & leachables and manufacturing impurities ending up in the medicinal product.

We are working very closely with a multinational biopharmaceutical company focusing on establishing safe exposure and maximum residue levels of impurities that are present in the medicinal product unintentionally, either from the manufacturing process, the drug delivery system or the drug container; or through cross-contamination in shared manufacturing facilities. All our assessments follow a template agreed upon with our client. They are timely to avoid any market release issues, are state-of-the-art in terms of toxicology information, and in compliance with the respective ICH guidelines. For impurities for which scarce toxicological data can be identified, not permitting to derive a robust NOAEL, we typically follow new risk assessment type of approach, including QSAR modelling, analogue-based read-across assessment or the TTC approach.