Alternatives to Animal Testing

Alternatives to Animal Testing: The Science Has Moved On

The argument most often used to defend facilities like MBR Acres is that animal testing is a necessary part of the drug development process and that there are no adequate alternatives. This argument is increasingly difficult to sustain. A growing body of scientific evidence and a rapidly developing range of non-animal methodologies (NAMs) demonstrate that the science has moved well beyond animal models — even if the regulatory framework has not.

The Problem with Animal Models

The fundamental challenge with using animals — including beagles — as models for human drug responses is that they are not human. Studies have shown that animal models predict human outcomes in only 8 to 10 per cent of cases for some drug types. Nine out of every ten drugs that pass animal testing subsequently fail in human clinical trials. This is not a minor margin of error — it reflects a fundamental mismatch between the biology of non-human animals and the biology of the human beings these drugs are intended to treat.

This failure rate has significant consequences: it means that drugs that would harm humans sometimes pass animal testing, and drugs that would help humans sometimes fail it. Neither outcome serves patients.

Non-Animal Methods Currently Available

Organ-on-a-Chip Technology

Organ-on-a-chip devices are miniaturised human organ models built on microfluidic chips. They replicate the physical and biochemical environment of human organs — lungs, hearts, livers, kidneys — at a scale small enough to be manipulated in a laboratory. Because they use actual human cells, they produce responses that are more predictive of human drug responses than animal models. Researchers at institutions including Harvard’s Wyss Institute have demonstrated their utility across multiple organ systems.

Artificial Intelligence and Machine Learning Drug Modelling

Machine learning algorithms trained on the chemical structures and biological activity data of millions of compounds can predict the toxicity, efficacy, and pharmacokinetic properties of new drug candidates with increasing accuracy. AI-driven drug discovery platforms are already being used by pharmaceutical companies to screen candidate molecules before any biological testing — animal or human — takes place. This reduces the number of compounds that need to progress to testing at all.

3D Cell Cultures and Organoids

Traditional two-dimensional cell cultures — flat sheets of cells grown in a dish — do not accurately replicate the behaviour of cells in a living three-dimensional tissue. Three-dimensional cell cultures and organoids (miniature organ-like structures grown from stem cells) behave much more like real human tissue. They can be used to test drug candidates in an environment that more closely resembles the human body than either 2D cultures or animal models.

Human Volunteer Microdosing Studies

Phase 0 microdosing studies involve administering very small, sub-therapeutic doses of a drug candidate to human volunteers. The doses are too small to have a therapeutic or toxic effect, but large enough to provide pharmacokinetic data about how the human body processes the compound. This provides direct human data at the earliest stage of drug development, before animal testing would traditionally take place.

In Silico (Computer) Modelling

In silico modelling uses computational techniques to simulate biological processes. Physiologically based pharmacokinetic (PBPK) models can predict how a drug will be distributed, metabolised, and eliminated by the human body. These models are already accepted by regulatory agencies including the FDA and EMA as part of drug approval dossiers.

The Regulatory Gap

The European Union has committed to phasing out animal testing as part of its chemicals strategy. The UK has not made a comparable commitment, and UK regulatory requirements still mandate animal testing for many categories of drug and chemical. This regulatory inertia — not scientific necessity — is one of the primary reasons facilities like MBR Acres continue to operate.

The science has moved on. The regulatory framework has not kept pace. Camp Beagle calls on the UK government to align regulatory requirements with current scientific capabilities and to invest in the validation and adoption of non-animal methods.