Tuesday, February 18, 2014

Toward Three-Dimensional Liver Bioassays

Today, we present a spotlight from BioProcess International Magazine, looking closer at three-dimensional assays.  Read the full report here.

The Hamner Institutes for Health Sciences of Research Triangle Park, NC, has formed a research initiative to develop more realistic 3D tissue bioassays for in vitro toxicity testing. With support from the American Chemistry Council, this program should produce better human tissue surrogates than are currently available by implementing the vision of a 2007 National Academies of Sciences (NAS) report. Toxicity Testing in the 21st Century advocated new in vitro approaches to chemical safety sciences. These new technologies could enhance human relevance of test results and significantly improve product stewardship and responsible care efforts. The research program also could have implications on improving drug safety through a collaborative effort with scientists at The Hamner-UNC Institute for Drug Safety Sciences, a Hamner collaborative program with the University of North Carolina.

Current 2D liver cell cultures are viable in vitro for only about one week, making them suitable for studying acute conditions. But 3D cultures are viable for four to eight weeks, which enables studies of more prolonged exposure to chemicals. Researchers will use multiple cell types to replicate the architecture of a human liver in their laboratory. As this program matures, they will consider similar approaches for other tissues: e.g., lung, kidney, and heart. For the program’s initial phase, novel cell culture systems will be developed and evaluated. The most promising technologies will move forward to validation for more routine use in toxicity testing.

“We are very pleased to have Dr. Edward LeCluyse join us to lead this new program,” said Melvin Andersen, director of the Institute for Chemical Safety Sciences. “Ed is a world-renowned specialist in this area, and we feel extremely fortunate to have someone with his track record and ability to work collaboratively. His expertise will help accelerate the efforts toward establishing better, human-relevant approaches to risk assessments and the acceptance of the approaches outlined in Toxicity Testing in the 21st Century.”

The NAS report envisions a major effort to advance the science of toxicity testing and foster implementation into everyday practice. The new paradigm should generate improved data on potential risks to humans posed by exposure to various agents and assess chemicals more efficiently than ever before. A stronger scientific foundation offers the prospect of improved risk-based regulatory decisions and greater public confidence in the decisions. Andersen is a coauthor of the report.

LeCluyse previously served as scientific director for HepaShear, part of HemoShear LLC, where he helped develop an advanced human surrogate model of the liver to be used as a tool for drug discovery and the study of liver disease. The Hamner Institutes for Health Sciences is a nonprofit research organization building on 35 years of research in toxicology and human health research to develop and validate new cutting-edge tools for safety assessment. Novel technologies currently being developed include in silico models for predictive toxicology, in vitro models that use human cells or cell lines to evaluate perturbations of cellular responses, and in vivo models to elucidate genes that play a role in susceptibility to drug-induced toxicities. 

This year at the Bioassays Event, Abhishek Mathur, Ph.D., Senior Scientist, Function Biocharacterization of Amgen Inc will on hand to present a similar perspective on in-vitro bioassays testing during his presentation Impact of Aggregates on In-Vitro Bioassays.  For more information on his session and the rest of the program, download the agenda.  If you'd like to join us May 5-7, 2014, as a reader of this blog, when you register to join us and mention code B14177JT, you are eligible to save 20% off the standard rate.

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