Approximately 150,000 laboratory animals are used each year in the EU for viral safety testing of human or veterinary medical products. Although international guidelines require animal testing for routine quality control (QC) of biologics such as vaccines, there are several drawbacks to this approach.
From a technical perspective, animal-based assays are:
- indirect methods which are biased by the type of animal or cell line used
- highly limited relative to the scope of viruses detected
- not 3R (Reduce, Replace, Refine) compliant
- time-consuming with a turnaround time of up to 6 months
Because of the above technical limitations, traditional QC testing options for biologics fail to meet most biopharmaceutical companies’ expectations in terms of development timelines and budget limitations.
While the biopharmaceutical industry is interested in changing using alternatives to animal models, there are challenges related to validation, harmonization, and regulatory acceptance.
Regulatory bodies are currently evolving and encouraging 3R initiatives like the use of molecular-based methods to replace animal and cell-based assays. While alternatives methods such as PCR/qPCR are 3R compliant and provide a faster testing approach compared to animal models, they are subject to bias in the event there is a sequence mutation or more challenging when testing large panels of viruses.