Ensuring quality of in vitro alternative test methods: Current practice

Area of Science:

• Toxicology
• Biotechnology
• Regulatory Science

Background:

• In vitro toxicology methods are increasingly validated as alternatives to animal testing by regulatory agencies.
• These methods often utilize ex vivo tissues or proprietary bioconstructs, necessitating quality assurance for data reliability.
• Users require confidence in the consistency and quality of data generated by these assays over time.

Purpose of the Study:

• To present an overview of current approaches for ensuring the reproducibility and high quality of in vitro alternative testing methods.
• To address the need for consistent data matching validation standards for regulatory acceptance.

Main Methods:

• Full characterization of cells or tissues used in assays.
• Sampling of each lot of manufactured bioconstructs to assess performance.
• Regular use of control materials and benchmark chemicals to monitor assay consistency.

Main Results:

• Implementation of comprehensive quality control strategies by manufacturers and contract testing laboratories.
• Demonstration of methods to assure consistent assay performance over time.
• Validation of approaches to meet regulatory standards for in vitro toxicology data.

Conclusions:

• Established quality assurance practices are essential for the reliable application of in vitro toxicology methods.
• Consistent data quality from in vitro assays supports their adoption as alternatives to animal testing.
• Ongoing monitoring and control are key to maintaining the integrity of results from alternative testing methods.