Pharmaceutical Industry

gentronix_internal_headers_Pharma03

Pharmaceutical Industry

Early In vitro screening for genotoxicity

  • Saves money and improves productivity
  • Enables Medicinal Chemists to modify compounds to reduce genotoxicity without losing desirable properties

Further assays to understand the causes of positive results

  • Clearer decision to keep or reject candidate
  • Additional information to take forward to In vivo studies

 Why screen early?

Late stage withdrawal of candidates is a factor contributing to unacceptable attrition rates across the pharmaceutical industry, and the rising cost of bringing a new therapeutic agent to market: latest estimates being between $800M and $1.2B per successful launch. One factor that contributes to overall attrition rates is the potential for a compound to cause damage to DNA (genotoxicity).

In order to guard against genotoxic compounds being developed into drugs (with the exception of certain drug classes e.g. cancer chemotherapeutics where damage to DNA is a core component of the drugs mode of action) it is a regulatory requirement that all pharmaceutical compounds undergo pre-clinical safety testing. Such testing becomes more expensive the later it occurs in the process as the cost of rejection a candidate increases the closer it occurs to clinical testing.

The very high levels of both sensitivity and specificity achieved with GreenScreen HC and BlueScreen HC, provides a valuable insight into genotoxicity liability; often at a very early screening stage in compound development. This represents a direct and very important benefit when considering the essential requirement to provide laboratory and manufacturing staff personal protection in terms of Health and Safety.

When to Screen

The earlier a compound is screened the greater the cost and time saving. The cost of rejecting a candidate based on genotox screening at the Lead Optimisation stage is more than 10x greater than if it had been rejected at the profiling stage. In addition, the opportunity to modify the compound, to make it safer, is correspondingly reduced.