Pre-clinical assays, including in vitro assays, rely heavily on suppliers who provide essential products or services. In the current regulatory environment, the burden is placed on the users of these products or services to ensure that the methods employed at the suppliers' facilities meet a sufficient level of quality. Variable results for the same assay controls over time could indicate high lot-to-lot variability of the test system or of critical assay components. (more…)
Human precision-cut lung slices (hPCLS), considered a highly relevant ex vivo model of the lung, offer native architecture and cells of the lung tissue including respiratory parenchyma, small airways, and immune competent cells. However, the irregular availability of donor lungs has limited the accessibility of this system. As described here, thousands of hPCLS can be created from 1 lung, cryopreserved, and used “on demand” by applying slicing and cryopreservation methodology improvements. (more…)
IIVS is excited to announce a new publication in Science with co-authors at Boston University and Mechanobiologix (Newton, MA, USA)! Abstract: Emphysema is a debilitating disease that remodels the lung leading to reduced tissue stiffness. Thus, understanding emphysema progression requires assessing lung stiffness at both the tissue and alveolar scales. (more…)
The Institute for In Vitro Sciences (IIVS) is sponsoring a series of workshops to identify, discuss and develop recommendations for optimal scientific and technical approaches for conducting in vitro assays, to assess potential toxicity within and across tobacco and various next generation nicotine and tobacco products (NGPs), including heated tobacco products (HTPs) and electronic nicotine delivery systems (ENDS). (more…)
IIVS is pleased to announce the co-publication of several respiratory-based articles highlighting: the characterization and recommendations for non-animal techniques used to model mucociliary clearance in human-derived test systems, the dosimetry of tobacco products for in vitro testing and a third article covering the use of New Approach Methodologies to nicotine containing products in a regulatory environment.Use of New Approach Methodologies (NAMs) to Meet Regulatory Requirements for the Assessment of Tobacco and Other Nicotine-Containing Products
Thank you to all who visited our booth or poster sessions at the 2022 Society of Toxicology annual meeting. If you would like copies of any of the poster presented we now have them available to view online (more…)
IIVS is excited to announce the publication of 2 papers evaluating the use of predictive models in combination with in vitro assays to provide a quantitative assessment of skin sensitization potential. This work is presented Drs. Frank Gerberick (GF3 Consultancy, Chief Scientific Advisor to IIVS) and Andreas Natsch (Senior Research Fellow at Givaudan ) (more…)
Happy New Year! IIVS is pleased to greet 2022 with the announcement of a joint publication with the Research Institute for Fragrance Materials (RIFM) involving the evaluation of photoirritation potential of over 100 compounds. This effort, spanning the course of 7 years, involved a tiered testing approach with the application of 3 OECD test guidelines: TG 101, 432 and the recently accepted 498, which codifies the acceptance of Reconstructed human Epidermis as a model for assessing this endpoint. Read the full article here.
Regulatory bodies, validation authorities, method developers, and industry toxicologists realize the need to increase confidence in the scientific validity of novel in vitro methods – especially those being proposed for regulatory application .