Our team has many years of experience in preparing toxicological assessments required in the pharmaceutical sector. We regularly provide our clients with assessments of novel or unexpected impurities, excipients and other intentionally-added substances, and extractables and leachables.
Companies are required to generate an enormous array of data on their APIs. We are expert in summarising toxicity, ADME and pharmacology data. We also work closely with specialists in regulatory affairs and, together, we can assist in preparing the non-clinical sections of a dossier for submission.
The toxicological assessment of impurities in drug products poses a particular challenge as, in most cases, no substance-specific data exist. We have developed a workflow to combine our extensive expertise with in silico ((Q)SAR) models and TTC (threshold of toxicological concern) concepts to establish the safety of pharmaceutical impurities.
A thorough assessment of potential extractable and leachable substances arising in drug products from containers and packaging is another key requirement. We have long-standing partnerships with several high-quality analytical laboratories, providing a holistic approach to the generation and evaluation of data.
Where multiple APIs (active pharmaceutical ingredients) are produced in the same facility, it is critical to set sound toxicology-based exposure limits to ensure the safety of all products. We are very experienced in following the appropriate guidance from EMA and other authorities to establish these limits.
Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.
We strive to help clients fill data gaps without a potentially costly and animal-intensive trip to the testing laboratory, by using computer models to predict the toxicological characteristics of an untested compound.
Generating new TK data involves the use of animals, is time consuming and extremely costly (particularly if radiolabels are required). We make expert predictions, taking into account known toxicity data, structure and physico-chemical properties.
Case study
The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.
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.
Case study
Following analytical studies on an intravenous drug product, an organic leachable from the container closure system (CCS) was detected, identified and quantified.