Author: Mitchell Gaydash
Toxicity and Inflammatory Response to Common Magic Mouthwashes in a 3D Oral Reconstructed Tissue Model
November 8, 2023Magic 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...
Safety Assessment of Monographed OTC Cold/Cough Medicine Using an In Vitro Testing Platform Based on Human Reconstructed Oral Tissues
November 8, 2023Over-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...
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...
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, 2023Human 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...
Key Recommendations from GIVIMP for Test System Suppliers
October 10, 2023The 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...
Webinar Series on In Vitro Phototoxicity Testing
September 20, 2023Thank you for joining us for a two-part webinar series on in vitro phototoxicity testing co-organized by the Institute for In Vitro Sciences (IIVS) and PETA Science Consortium International. Part 1 included a methodological overview on phototoxicity assays, and Part 2 covered case studies from industry applying the methods. Webinar 1: In Vitro Phototoxicity Testing Part 1: Methodological Overview Presenters: Allison Hilberer, MS, IIVS and Satomi Onoue, PhD, University of Shizuoka Webinar 2: In Vitro Phototoxicity Testing Part 2: Application Case Studies Presenters: Gretchen...
IIVS Partners with SkynFuture to Further In Vitro Research Techniques
September 18, 2023IIVS is pleased to announce a partnership with SkynFuture, a cosmetics and skincare brand within the UniAsia cosmetics company. IIVS and SkynFuture will collaborate to develop and optimize human-relevant research and testing methods to assess the safety and efficacy of skincare products, and conduct training and other activities to advance non-animal test methods in China. ...
Incorporating GIVIMP Recommendations into Method Development, Use, and Transfer
August 30, 2023The 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. In order to bridge the gap between development and...