Alternatives to animals testing
Safety and efficacy testing
The current regulations in developed countries impose strict controls on any new product for human use that are potentially dangerous for human health.
For safety and efficacy reasons, new drugs, cosmetics, food additives, sun creams and other chemicals undergo very strict tests before being authorized. Until recently, these tests involved the use of thousands of animals. For ethical reasons and in application of European directives (including EU 86/609 / EEC), alternative techniques must be developed. Indeed, animal testing is "prohibited when rational and applicable alternative methods exist".
On the other hand, the results obtained using animals as experimental substitutes for humans cannot formally predict their effectiveness, and especially their potentially dangerous side effects in humans. Thus, 95% of effective anti-cancer drugs in animal models have been shown to be ineffective in clinical phase trials (1). As another example, the clinical trial of the anti-CD28 antibody, administered at a 500 times lower dose than that used (and well tolerated) in non-human primates, endangered the lives of all volunteers that received this treatment (2). Therefore, awareness of the need to develop in vitro testing directly on human tissues increased these last decades.
Our goal is therefore to help towards improving pre-clinical study strategies, reduce the risks of the clinical phases and ultimately allow the development of more effective and safer products.
1. R.A. Coleman, Int. Scholarly Research Network, ISRN Pharmaceutics, 2011.
2. G. Suntharalingam et al., The New England Journal of Medicine, 2006.
New European Regulations
With increasing awareness of the public opinion, and reinforcement of European directives, significant progress has been made to develop alternatives to animal testing.
the 3R principle: reduction, refinement and replacement of animal experiments in research.
the ban on animal experiments to test cosmetic products.
Towards a more ethical research
Despite progress already made for more ethical research, there is still a long way to go…
In force since 2013 in the EU, the regulation on cosmetics prohibits not only animal testing for the ingredients that make up the products, but also the import of any product that does not meet the conditions of the directive. Unfortunately, the European ban only led to a slow emulation and a lot of countries worldwide still allow animal testing.
FDA adheres to the Animal Welfare Act and the Public Health Service Policy of Humane Care and Use of Laboratory Animals and supports the development and use of alternatives to whole-animal testing. FDA also adheres to the use of the most humane methods available within the limits of scientific capability when animals are used for testing the safety of cosmetic products. However, there is still no nationwide ban on cosmetic animal testing across the USA as of June 2021, only 5 states have banned it.
Alphenyx strives to propose models and tools, developed from surgically discarded human tissues to contribute to the reduction of animal testing and help research to move forward to a more ethical experimentation.
We therefore especially thank all the voluntary donors. They are the anonymous allowing to reduce animal testing and helping the research to work in a more ethical way while developing safe and efficient products (drugs, cosmetic, sun cream…) for everyone’s benefit.