Posters & Presentations

Toxicity and Inflammatory Response to Common Magic Mouthwashes in a 3D Oral Reconstructed Tissue Model

November 8, 2023

Magic Mouthwash is a general term describing oral rinses prescribed by a doctor for the treatment of pain, inflammation, or infection, commonly as a result of chemotherapy and radiation induced oral sores (oral mucositis). There is no set combination of ingredients for the preparation of a magic mouthwash, rather they are formulated for the individual needs of each patient, selecting from an array of various active ingredients. Although the ingredients most commonly used to formulate Magic Mouthwashes are considered safe as prescribed, the final formulations lack toxicity and inflammatory response data. (more…)

Safety Assessment of Monographed OTC Cold/Cough Medicine Using an In Vitro Testing Platform Based on Human Reconstructed Oral Tissues

November 8, 2023

Over-the-counter (OTC) products are available to alleviate concurrent symptoms of colds and flu. They are primarily based on a combination of decongestants, antitussive and alpha adrenergic agonists, which are well-established pharmaceutical agents covered by U.S. monographs. Many of the active components of the OTC cough/cold drugs are bitter and must be masked using flavoring agents. Bayer internally employed a stringent safety testing program for OTC cough/cold medicine line extensions that require the products to be held in the mouth for a short period using an innovative testing platform based on reconstructed oral tissues. (more…)

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). (more…)

Ensuring the quality of a test system using the principles of Good In Vitro Method Practices (GIVIMP): A case study of cryopreserved human precision-cut lung slices

October 10, 2023

Human precision-cut lung slices (hPCLS) are a highly relevant 3-dimensional model of the lung. They offer native architecture and cells of the lung tissue including respiratory parenchyma, small airways, and immune competent cells involved in inflammatory and sensitization processes. The scarcity of human lung tissue available for research and the inability to conduct larger scale testing has limited the use of hPCLS as a test system for routine, high-throughput testing. To overcome this barrier, IIVS has refined the methodology behind the cryopreservation, storage, thaw and post-thaw maintenance of human lung slices. As primary tissues have varied quality and responsiveness, a standardized performance characterization (PC) is conducted on all donor batches. (more…)

Key Recommendations from GIVIMP for Test System Suppliers

October 10, 2023

The 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. An important part of (and a source of potential high variability in) any method is the test system. Microphysiological Systems (MPS), including organ-on-a-chip platforms have been used in novel methods for many years. Despite their potential benefits, there are several quality concerns associated with MPS. Two of these concerns are reproducibility and well defined and understood biological relevance, both of which are covered in the GIVIMP guidance. (more…)

Incorporating GIVIMP Recommendations into Method Development, Use, and Transfer

August 30, 2023

The demand for toxicology data from human-relevant, New Approach Methodologies (NAMs) continues to increase. Fortunately, the scientific community has responded with new tools based on human tissues and cells. The creators of these systems and test methods utilizing them have invested in their development and also in studies designed to demonstrate their relevance, reproducibility, and transferability. Despite these efforts, scientific confidence in these methods at the regulatory level remains comparatively low. (more…)

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. (more…)

Good In Vitro Method Practices Certification: A Roadmap for Implementation and Harmonization

October 7, 2022

The 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.

IIVS Workshop Series: Identification, Discussion and Recommendations for the Optimal Generation and Use of In Vitro Genotoxicity Assay Data for Tobacco and Nicotine Products

October 18, 2019

The Institute for In Vitro Sciences (IIVS) is sponsoring a series of workshops to identify, discuss and develop recommendations for optimal scientific/technical approaches for utilizing in vitro assay data within and across tobacco and nicotine product categories. Workshops provide a unique opportunity for invited expert stakeholders to share experiences and to develop recommendations that may serve as a resource for developing optimal approaches and data to evaluate the toxicity of tobacco and nicotine products. It is envisioned that some of these recommendations would form the basis for the generation of guidance documents and/or serve as authoritative reference publications for optimal methodologies and data interpretation and to support regulatory submissions. Invited experts for the IIVS workshops include scientists from tobacco companies, contract research organizations, US regulatory agencies, and other in vitro assay experts with tobacco product and/or genetic toxicology experience. The format for this workshop series is primarily discussion among participants which provides an environment to tackle issues in detail. Participants are expected to actively participate by collecting relevant published and unpublished non-proprietary research information, to offer experiences and expert opinions, and to actively share with other workgroup members. While the focus will be on the widely used regulatory in vitro genetic toxicology assays, it is important to note that much of the discussion will be applicable to all in vitro assays. As a part of the workshop discussion, data gaps will be identified. Thus, in addition to recommendations based on current information, this workshop series will provide key research questions that need to be addressed by the scientific community. This will provide a useful roadmap for research that can have direct impact on the regulation of tobacco products and on protecting human health related to consumer use of tobacco products. The product of these workshops will be a series of scientific publications and meeting presentations that can be utilized by all stakeholders. Prior to the first workshop (November 27-28, 2018) important issues for using in vitro genotoxicity assays for evaluating tobacco and nicotine products were identified. During the first workshop issues were triaged into three priority categories based on the amount of available information.

Use of Ex Vivo Precision-Cut Lung SLices as a Screening Tool for Potential Respiratory Toxicity of E-Liquids

October 17, 2019

The Family Smoking Prevention and Tobacco Control Act gave the FDA regulatory authority over next generation tobacco products (NGTP) such as E-vapor products. E-vapor product liquids contain a variety of ingredient combinations that should be assessed for human risk. One human lung-relevant testing platform with reasonable throughput, is human precision-cut lung slices (HuPCLS). HuPCLS are arguably the most complex non-animal model of the lung, retaining native architecture and immune-competent cells over multi-week culture periods. HuPCLS were exposed to three concentrations (0.1%, 0.5%, and 1.2%) of propylene glycol (PG ; an E-vapor product constituent) continuously for 16 days. Exposure-effects were evaluated biochemically (WST-8 assay) and histologically viability assessment of H&E stained slides). Positive control treatments consisted of 10μM Phortress and 13μM bleomycin. HuPCLS were fed every day with fresh medium ± treatment and harvested at days 4, 8, and 16. Untreated control UC) HuPCLS viability was confirmed using protein and a denylate kinase assays. Over 16 days in culture, UC lost 30% viability while WST-8 results indicated no loss over 16 days in culture. Phortress caused severe damage by day 4 and bleomycin by day 8 (histologically & WST-8 viability). Prolonged 1.2% PG exposure diminished WST-8 viability by ~30% at day 16 which agreed with histological results. High osmolality is the suspected mechanism of toxicity. There was no effect histologically or via WST-8 viability for prolonged exposure to 0.1% and 0.5% PG. In summary, PG, a common E-vapor product ingredient, at 1.2% had adverse effects in a human pulmonary model in an exaggerated exposure regimen(prolonged exposures with changes in osmolarity). The HuPCLS platform has huge potential to serve as a screening tool for e-liquid(and other materials of concern) by elucidating potentially relevant, long-term events following NGTP ingredient exposure.