Documents & Resources

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

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

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…)

Webinar Series on In Vitro Phototoxicity Testing

Thank 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. 

Incorporating GIVIMP Recommendations into Method Development, Use, and Transfer

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…)

Multiscale Stiffness of Human Emphysematous Precision-Cut Lung Slices

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. (more…)

IIVS Financial Conflict of Interest in Research Policy

IIVS Posters – SOT 2023 Annual Meeting

IIVS presented several posters at SOT 2023. This post includes links to the full PDF versions of each poster presented. (more…)

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

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). (more…)

Derivation of a Point of Departure from In Vitro Methods for use in Skin Sensitization Risk Assessment Pt 2

This webinar explores the use of Non-Animal Methodologies to derive a Point of Departure (predicted LLNA EC3) which can be used to evaluate the skin sensitization potency as well as downstream use for risk assessment. Presenters include: Dr. Argel Islas-Robles (Study Director and Toxicologist, IIVS) and Dr. Andreas Natsch (Senior Research Fellow, Givaudan...

Derivation of a Point of Departure from In Vitro Methods for use in Skin Sensitization Risk Assessment Pt 1

This webinar explores the use of Non-Animal Methodologies to derive a Point of Departure (predicted LLNA EC3) which can be used to evaluate the skin sensitization potency as well as downstream use for risk assessment. Presenters include: Dr. Argel Islas-Robles (Study Director and Toxicologist, IIVS) and Dr. Andreas Natsch (Senior Research Fellow, Givaudan...