How automated tools can speed toxicology tests 

The process of bringing a new drug to market in the UK is extensive, typically spanning several years. This timeline encompasses drug discovery, preclinical studies, including toxicology profiling, clinical trials and regulatory approval.

Toxicology profiling is a critical component of preclinical studies, essential for assessing a drug's safety before human trials.

Typically, toxicology profiles can take up to a fortnight to generate, depending on the availability of toxicologists or capacity at a specialist consultancy. Ultimately, this time delay in generating toxicology profiles slows down product development processes, which, in turn, increases time to market and reduces profitability. 

However, this does not need to be the case as there are ways to improve the efficiency of this process. Using previous information available to drug developers and contract research organisation alike, along with automated tools, profiles can be generated in a few clicks.

Delay in generating toxicology profiles slows down product development processes, which, in turn, increases time to market and reduces profitability

In addition, having automated tools specifically for toxicology can work in tandem with other tools that allow for greater efficiency across the production process – which can allow for cross referencing and risk assessment beyond toxicology and inform other processes including stability studies. This is an example of linking up other analytical data required, such as extractables and leachables which can examine linking materials from devices to chemicals they may come into contact with – making this an assessment of all of the product ingredients.

Broughton has developed Tox HQ, a chemical repository that stores the properties of over 400 chemicals, including hazard assessments, health-based guidance values and in vivo/in vitro toxicological information. With this repository, toxicology profiles are created at the press of a button using existing data which is constantly being reviewed and updated. For any customer looking to bring a particular new product to market, a specific or bespoke toxicology report can be auto generated within this database, instantly providing savings by reducing lead times.

By storing all of the toxicology data in one place, the repository can utilise key information to perform risk assessments on formulations, products and datasets.

By utilising data from the repository or provided as ‘blinded’ data by a customer, these risk assessments are created on screen as the formulation is built, allowing a real time opportunity to make changes to a product or formulation. In addition, such toolshave a confidential nature to them, including a secure area for customers that even the consultancy may not have access to – allowing risk assessments of materials and liquids to have strict access control.

Though ToxHQ was originally designed for e-cigarette product development, this platform caters for all new generation nicotine products as well as products and formulations in both pharmaceutical and medicinal cannabis sectors. As long as the chemical information exists, or is provided, the platform can be used in a multitude of different ways.

Product developers at any stage of the process can use it, whether that’s early testing at the prototype phase to assess what should and shouldn’t be included in the final product, or final testing to generate a toxicology profile or risk assessment for a product ahead of regulatory submission.

Dean Hatt is senior toxicology consultant and toxicology manager at contract research organisation Broughton