Documents & Resources

Assessment of In Vitro COPD Models for Tobacco Regulatory Science: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

On 8-10 December 2014, IIVS organised a workshop conference, entitled Assessment of In Vitro COPD Models for Tobacco Regulatory Science, to bring together stakeholders representing regulatory agencies, academia, industry and animal protection, to address the research priorities articulated by the FDA-CTP. Specific topics were covered to assess the status of current Assessment of In Vitro COPD Models for Tobacco Regulatory Science technologies as they are applied to understanding the adverse pulmonary events resulting from tobacco product exposure, and in particular, the progression of chronic obstructive pulmonary disease (COPD). The four topics covered were: a) Inflammation and Oxidative Stress; b) Ciliary Dysfunction and Ion Transport; c) Goblet Cell Hyperplasia and Mucus Production; and d) Parenchymal/Bronchial Tissue Destruction and Remodelling.

Read article.

Multiparametric Image Analysis of Rat Dorsal Root Ganglion Cultures to Evaluate Peripheral Neuropathy-Inducing Chemotherapeutics

Chemotherapy-induced peripheral neuropathy (CIPN) is a major, dose-limiting adverse effect experienced by cancer patients. Advancements in mechanism-based risk mitigation and effective treatments for CIPN can be aided by suitable in vitro assays.  To this end, we developed a multiparametric morphology-centered rat dorsal root ganglion (DRG) assay.

Read article.

Precision Digital Dispensing of Patterned Picoliter Quantities of Test Material onto Apical Surfaces of Human 3D-Reconstructed Airway Tissues

There is an increasing need for researchers to understand the dynamic aspects of inhaled tobacco product exposure. Available 3D human reconstructed airway tissues (RHuA) provide researchers with a more physiological platform that offers apical and basal compartments for flexibility in modelling relevant exposures. We have tested the Tecan D300 digital dispenser as potential technical solution to deliver precise amounts of very small vehicle droplets to coat the apical surface of an available RHuA.

Addressing the Assignment of US EPA Hazard Categories for Dermal Safety by a Revised Prediction Model of the Validated In Vitro Skin Irritation Test (OECD TG 439)

One of the current goals of the United States Environmental Protection Agency Office of Pesticide Programs (US EPA OPP) is to replace by non-animal testing methods as many of the endpoints of the battery of acute toxicity tests known as the “6-pack” as possible. One of the “6-pack” tests is the Draize rabbit test for dermal irritation. We investigated whether the validated in vitro Skin Irritation Test (SIT, OECD TG 439) can be used to determine US EPA OPP dermal hazard category assignment.

The 3D Human Reconstructed Skin Micronucleus Assay (RSMN) Using the EpiDerm Tissue: Validation and Application to the Safety Assessment of Cosmetics Ingredients

Regulatory restrictions on animal use have increased the reliance of risk assessors and regulators on in vitro test systems. Ideally, tissue-based assays could replace the animal studies as follow-up tools to verify results from standard in vitro assays. The RSMN assay combines the EpiDerm™ 3D reconstructed skin (RS) model with the micronucleus (MN) assay to provide a more realistic model for evaluating the genotoxic potential of dermally applied chemicals or products, such as cosmetics.

In Vitro Models Available for Testing of ENDS

Presented at the National Academies of Sciences, Engineering, and Medicine's (NAS) workshop on electronic nicotine delivery systems (ENDS), e-cigarettes.

Case Study: Applying GLPs to New, Non-Animal Methodologies

Presented at the 2nd Good Laboratory Practice Compliance Summit, January 26-27, 2017, Arlington, VA

In Vitro Assessment of Skin Irritation Potential of Surfactant-based Formulations by Using a 3-D Skin Reconstructed Tissue Model and Cytokine Response

The personal care industry is focused on developing safe, more efficacious, and increasingly milder products, that are routinely undergoing preclinical and clinical testing before becoming available for consumer use on skin. In vitro systems based on skin reconstructed equivalents are now established for the preclinical assessment of product irritation potential and as alternative testing methods to the classic Draize rabbit skin irritation test. We have used the 3-D EpiDerm™ model system to evaluate tissue viability and primary cytokine interleukin-1α release as a way to evaluate the potential dermal irritation of 224 non-ionic, amphoteric and/or anionic surfactant-containing formulations, or individual raw materials. Full article available to full and paid subscribers of ATLA.

The Use of Human 3D Reconstructed Airway Cultures for Tobacco Product Evaluation: Precision Low-Volume Exposures at the Apical Site

With a mandate to evaluate the dynamics of pulmonary exposure to inhaled materials such as tobacco-based products, researchers are employing complex, human, three-dimensional pulmonary models. Human reconstructed airway (RHuA) tissues present a platform that more closely resembles airways in vivo. Grown at the air–liquid interface (ALI), RHuA tissues offer apical and basal compartments that allow flexibility in modeling physiologically relevant exposures and provide sampling location-specific results. Read the full article.

Trends in Regenerative Medicine: Repigmentation in Vitiligo Through Melanocyte Stem Cell Mobilization

Vitiligo is the most frequent human pigmentary disorder, characterized by progressive autoimmune destruction of mature epidermal melanocytes. Of the current treatments offering partial and temporary relief, ultraviolet (UV) light is the most effective, coordinating an intricate network of keratinocyte and melanocyte factors that control numerous cellular and molecular signaling pathways. Read the full article.