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Considering Test Methods’ Impact on Your Brand

By: Brian Dell, Celsis Analytical Services
Posted: December 7, 2009, from the December 2009 issue of GCI Magazine.
  • Several drivers have rapidly evolved the thinking and approach of the scientific community as related to animal testing.
  • Improved reproducibility and consistency in lot-to-lot test data for highly correlated results are among the compelling business cases for use of in vitro test methods.
  • In vitro tests can be strategic tools that can significantly impact product development timelines and economic outcomes.

The drive to refine, reduce and/or replace animal-based testing of beauty products has significantly accelerated the demand for validated in vitro studies that can serve as viable replacements for animal testing. Spurred on by European Union (EU) legislation passed in March 2009 that banned animal testing of cosmetic ingredients and formulations, the move to in vitro testing formats is further being accelerated by the high development costs and lack of assay (procedures or methods for testing and/or measuring activity/efficacy) robustness that are typical of animal-based testing—such as the long-established Draize test to evaluate the acute toxicity of beauty products. By using in vitro assays in lieu of the traditional and often controversial practice of animal testing, brand owners and their manufacturing/testing partners are realizing benefits characterized by the four Rs: reduction, refinement, replacement and reproducibility.

With the drivers of cost reduction, performance optimization and a changing culture of acceptability around animal testing all aligned, it stands to reason that in vitro assay formats will only gain greater acceptance by regulating bodies that ensure product safety.

A Time for Change

During the last century, in vivo testing emerged as the preferred method to evaluate toxicity and to provide information on the potential dangers to humans from chemicals and personal products. Until recently, animal testing was a common “gate” that most products had to pass through before being available for human use. However, several drivers have rapidly evolved the thinking and approach of the scientific community as related to animal testing.

First, the ever-mounting pressure for brand owners to cut their costs and timelines to market is forcing researchers to find more efficient assays. The costs to care for laboratory animals and to develop and conduct validated animal studies are substantial, and limit the ability of young companies to compete. Particularly within the arena of drug or druglike product development, the timeline to develop and complete good manufacturing practice compliant pre-clinical studies can add years to a market launch date. Thus, current market forces will reward those who find effective ways to do more at reduced cost and without sacrificing consumer safety.