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 apporpriate assay endpoints. Several available test systems are summarized here.
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.
3D Reconstructed Tissues
3-dimensional reconstructed human tissues are derived from expanded stem cells and matured into preudostratified structures. They boast longevity in culture, multiple cell types and can contain features such as beating cilia, a mucus layer, and tight junction integrity to better model human physiology and functionality.
3D Precision-cut Slices
Perhaps the most relevant human tissue model, tissue slices offer all cell types and tissue substructures contained in the tissue core when sliced. While dependent on donor availability, recent advances in increased production and cryopreservation have made this model more accessible.