In silico assessment of impurities in a pharmaceutical
Case study
The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.
Derivation of a dermal HBEL for a hormone ester
Case study
Health-Based Exposure Limits (HBELs) are used to control risk when different medicinal products are manufactured in shared facilities.
N-Nitrosamines risk assessment for a pharmaceutical product
Case study
Bibra was asked to investigate two N-nitrosamines extracted from stoppers for vials used within the pharmaceutical sector.
Toxicological risk assessment of leachables from a combination product
Case study
The client was developing a ready-to-use (RTU) process for the administration of a viral-based product in a clinical setting. Bibra was requested to assist with the assessment of extractables during the development phase and leachables in the final RTU process - viral vector product.
Determining a suitable read-across surrogate for a pharmaceutical impurity
Case study
Following analytical studies on an intravenous drug product, an organic leachable from the container closure system (CCS) was detected, identified and quantified.