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Deriving a point of departure for assessing the skin sensitization risk of wearable device constituents with in vitro methods

September 24, 2024
Wearable devices are in contact with the skin for extended periods. As such, the device constituents should be evaluated for their skin sensitization potential, and a Point of Departure (PoD) should be derived to conduct a proper risk assessment. Without historical in vivo data, the PoD must be derived with New Approach Methods (NAMs). To accomplish this, regression models trained on LLNA data that use data inputs from OECD-validated in vitro tests were used to derive a predicted EC3 value,...

IIVS 2023 Impact Report

March 20, 2024
I am happy to present to you the Institute for In Vitro Sciences' (IIVS) 2023 annual report, marking my first year serving as President. It has been an honor to lead the IIVS team through a period of growth and transformation, and I am excited to share with you the progress we have made in advancing new approach methodologies in toxicological research. In addition to my appointment, we welcomed Kristie Sullivan, MPH to our team as the Vice President of...

January 2024 Newsletter

January 26, 2024
Coming soon to IIVS: The Reactive Oxygen Species (ROS) Assay for photoreactivity, a cost effective, high throughput approach that can screen test compounds of interest without the immediate need for more comprehensive (and expensive) assays.      ...

The Importance of Supplier Qualification for Vendors of Materials Used in In Vitro Assays

November 7, 2023
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. Though monitoring assay controls is useful to help...

Cryopreserved human precision-cut lung slices provide an immune competent pulmonary test system for “on-demand” use and long-term cultures

October 20, 2023
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. Fresh and cryopreserved (~7 and ~34 weeks; F&C) hPCLS...

A Laboratory Method to Measure Skin Surface Staining by Cigarette Smoke

October 20, 2023
Exhaled or side-stream cigarette smoke (CS) may visually stain a consumer’s skin over time. Tobacco heating prod- ucts (THPs) and e-cigarettes (ECs) have reduced staining potential because they do not produce side-stream aerosols and their exhaled aerosols have significantly reduced levels of toxicants, particles and odour. Here we assess discolour- ation of porcine skin in vitro after exposure to particulate matter (PM) or aerosols from CS (3R4F), two THPs (glo and glo sens) and an EC (iSwitch Maxx). PM was...

Multiscale Stiffness of Human Emphysematous Precision-Cut Lung Slices

May 22, 2023
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. Here, we introduce an approach to determine multiscale tissue stiffness and apply it to precision-cut lung slices (PCLS). First, we established a framework for measuring stiffness of thin, disk-like samples....

IIVS Posters – SOT 2023 Annual Meeting

March 31, 2023
IIVS presented several posters at SOT 2023. This post includes links to the full PDF versions of each poster presented. Application of a Performance Characterization Protocol for the Assessment of Normal and Diseased Cryopreserved Human Precision-Cut Lung Evaluation and Transferability of a New Approach Methodology to Address Photoallergy Evaluation of Complex Compounds in the UV-Vis Absorption Spectra General Behaviors of Surfactants in the Bovine Corneal Opacity and Permeability Modifications in the RhE Phototoxicity Assay to Evaluate Long-Lasting Cosmetic Products Optimization of an In Vitro Preclinical Screening...

Key Challenges and Recommendations for In Vitro Testing of Tobacco Products for Regulatory Applications: Consideration of Test Materials and Exposure Parameters

February 23, 2023
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). The third workshop (24–26 February 2020) summarised the key challenges and made recommendations concerning appropriate methods of test article generation and cell exposure from...