New Approach Methodologies (NAMs)
NAMs
New Approach Methodologies, referred to as "NAMs", are an integration of biological test systems and assay methodologies to address unmet needs in refining product development and evaluation. State-of-the-art technologies are combined with the current understanding of science to evaluate product efficacies and potential adverse events associated with exposure. Many human tissue-based test systems are available to assess key events in disease progression when coupled with appropriate assay endpoints. Several available test systems are shown here, with precision-cut tissue benefits summarized.
2D Primary Cells and Lines
2-dimensional cells have been extensively used for testing. Often grown as adherent cultures, primary cells offer more physiological-like properties, while lines can can be continually expanded and provide consistency across studies. 2D cells allow more cost-effective screening and testing paradigms, but are not considered a complex model, and typically limited to just one cell type.
3D Reconstructed Tissues
3-dimensional reconstructed human tissues are derived from stem cells and matured into preudostratified structures. They boast longevity in culture, can contain features such as beating cilia, a mucus layer, and tight junction integrity to better model human physiology. However, they are limited to just several cell types, do not contain tissue substructures or provide truly native architecture.
3D Precision-cut Slices
Perhaps the most relevant human tissue model, tissue slices offer native architecture, including tissue substructures not available in other models. All cell types are present in cores during slicing, including key immune cells involved in complex responses and disease progression.
Advances by AIV now allows production of 1000's of slices per donor and our proprietary CryoViable™ cryopreservation method allows banking of normal and diseased tissues, making this model accessible to researchers globally.