In vitro bioassays
The use of bioassays makes it possible to assess the safety and efficacy of a wide range of materials and substances.
Bioassays or in vitro assays are specialized techniques using organisms, which may include cell cultures, bacteria, fungi, insects, plants and arthropods, under controlled laboratory conditions.
What are in vitro bioassays used for?
They are used in several different areas of science to understand the reactions of an organism to the presence of one or more known or unknown substances. Reactions may include different negative effects such as cytotoxicity and genotoxicity, as well as positive effects such as protection against oxidizing agents. The use of bioassays therefore makes it possible to assess the safety and efficacy of a wide range of materials and substances, thus reducing the use of animal testing, which should only be used when no alternative methods exist, in keeping with the three Rs principle (replacement, reduction and refinement), as set out in EU Directive 2010/63.
What are the advantages of in vitro bioassays?
They enable effects to be assessed without the need to identify or quantify the substance.
- They make it possible to study the effects of mixtures to assess possible synergistic effects.
- They make it possible to assess the effects of substances present at very low levels.
- They reduce animal experimentation.
Types of in vitro bioassays
Depending on the effect to be evaluated, there are different types of in vitro bioassays to study the safety and/or efficacy of substances and materials. At AIMPLAS, we have biosafety laboratories with all the equipment required to carry out the following studies:
Evaluation of safety
- Cell viability or cytotoxicity using colorimetric, fluorometric and bioluminescent techniques to assess cell damage and/or survival. The methods include:
- MTT assay
- Neutral Red
- Alamar Blue
- Genotoxicity tests to assess DNA damage at different levels:
- Ames test (OECD TG 481) or bacterial reversion test to evaluate point mutations.
- Micronucleus test (OECD TG 487) for evaluation of numerical and structural chromosomal mutations.
- Comet assay (OECD TG 489) to measure DNA strand breaks, considered an indicator for detecting premutagenic lesions.
Evaluation of efficacy
- Evaluation of the antioxidant potential or protective effect against oxidative stress of a substance, ingredient or material.
- Studies of intestinal absorption.
- Evaluation of antimicrobial activity.
Bioassays are used to evaluate the safety or efficacy of a compound through the response of a living organism.
Biocompatibility refers to the ability of a biomaterial to perform a function according to a treatment without causing any adverse effects that could compromise cell viability and, as a result, the patient’s health.