Our work
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.
Actives
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.
Impurities
The toxicological assessment of impurities in pharmaceutical 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 Threshold of Toxicological Concern (TTC) concepts to establish the safety of pharmaceutical impurities.
Extractables and Leachables
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.
Cleaning Validation
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 pharmaceutical products. We are very experienced in following the appropriate guidance from the European Medicines Agency (EMA) and other authorities to establish these limits.
Our expertise in this area
Risk Assessment
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.
(Quantitative) Structure-Activity Relationships
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.
ADME/TK Assessments
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.
Some of our case studies in this area
Making sense of skin sensitisation
Blog articles
From cosmetics to cleaning products, skin allergy (sensitisation) is a prominent feature of our modern chemical-centric world. Put simply, this hazard is an abnormal reaction of the immune system which makes certain individuals overly sensitive to particular chemicals. Read more in our blog, to help you make sense of sensitisation.
Knowledge is key. Part 2: The bibra TRACE database (and supporting databank)
Blog articles
In Part 1, Peter Watts gave a potted history of his personal early experience in literature searching and toxicity data identification. Along with our colleagues of the same 'fine vintage', he weathered the storms of change, progressing from a time of back-strain (from carrying huge texts around) and index finger wear (turning pages) to dial-up and then to web-based searching. With your indulgence, Pete would now like to expand a little regarding TRACE and its value to clients and the bibra toxicologists.
Knowledge is key. Part 1: Toxicity literature searching, a personal history
Blog articles
Our Toxicology Director, Peter Watts, has written a very interesting article focussing on toxicity literature searching, from his own perspective (having been at bibra for 40+ years)
