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The Importance of Supplier Qualification for Vendors of Materials Used in In Vitro Assays
November 7, 2023Pre-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, 2023Human 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, 2023Exhaled 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, 2023IIVS 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, 2023IIVS 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, 2023The 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...
Experimental Toxicology and Ecology of BASF receives certification for Good In Vitro Method Practices
October 19, 2022Ludwigshafen, Germany and Gaithersburg, Maryland, USA – October 19, 2022 – The Institute for In Vitro Sciences (IIVS) certified BASF’s Experimental Toxicology and Ecology for Good In Vitro Method Practices (GIVIMP) based on the guidance document published in 2018 by the Organization of Economic Cooperation and Development (OECD). The GIVIMP document provides principles in quality management which, when implemented, serve to increase the quality and confidence in data generated by in vitro test methods. ...
Good In Vitro Method Practices Certification: A Roadmap for Implementation and Harmonization
October 7, 2022The Organization for Economic Cooperation and Development (OECD) guidance document on Good In Vitro Method Practices (GIVIMP) details a set of quality standards to improve both the quality of and confidence in newly developed, and routinely executed in vitro methods. Currently a practical guide to implement GIVMP standards is missing; leaving organizations to define the best approach for themselves. ...
May 2022 Newsletter
July 1, 2022The ability to ascertain the maximum limit of a compound that can be applied to the skin without inducing skin sensitization is a critical safety criterion for virtually any risk assessment. Using regression models developed by Givaudan (Kempthal, Switzerland), IIVS is able to perform a computational approach to determine predicted EC3 values (Effective Concentration required to induce a 3-fold upregulation of lymph node cell proliferation) using a combination of OECD approved assays (KeratinoSens, hCLAT, and kDPRA). This value can be used to assess risk for compounds to...