Animal-free DNA-based risk assessment promotes product safety in China

New market opportunities for AUREA gTOXXs

DNA repair with Aurea gTOXXs (lifePR) ( Tuttlingen, )
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by Paula Braun, Gudrun Prepens, Frank K. Gehring.

3T GmbH & Co. KG., Gartenstr. 100, 78532 Tuttlingen, Germany

DNA integrity at the heart of product safety

The integrity of the genetic information, the DNA, is absolutely vital for human health, both, for individual beings and for human mankind. Substances which damage DNA may spark diseases such as (lung) cancer, vascular disease and premature aging. If mutations impact on the germline, the resulting disease may affect all future offspring. Therefore, new ingredients for e.g. new drugs, cosmetics or nutrition, are subjected to ever-increasing quality control, including gene toxicology to assess their impact on the DNA. Novel alternative quality control tests push globally onto the market with the aim of replacing many of the largely unnecessary, as yet, frequently used animal experiments on a wide scale (1). AUREA gTOXXs is an alternative, animal-free risk assessment solution to ensure product safety at the level of DNA (2).

Growing awareness at China’s quality control market

China’s steady rise as a global economic powerhouse has seen it transform into one of the world’s foremost drivers of both production and demand, particularly, also in healthcare which is experiencing double-digit growth. While China’s pharmaceutical firms traditionally focus on improving existing technology and developing generics of new drugs (3) many of the new largely privately owned pharma firms such as Sino Biopharmaceutical and Jiangsu Hengrui are rapidly expanding their innovative capabilities. In addition, there are many large-cap international companies, by the likes of Pfizer, AstraZeneca and Novartis expanding into the Chinese market. There is a major incentive for progressing their efforts in ‘their own’ new drug discovery. This evolution entails implementation of new quality control tests and stimulates the growth of China’s CRO industries. With AUREA gTOXXs, 3T GmbH & Co.KG captures these new market opportunities in China’s CRO industries and health care sector.

Rapid assessment of drug agents, dietary supplements and cosmetic ingredients

China’s pharmaceutical and cosmetic industry regulatory environment has been under constant re-structuring. The trend is to better align the country with global regulatory norms by shortening the review timeline, increasing transparency and globalisation and, importantly, to incorporate stronger quality control (4,5). At the same time, a new set of regulations, about to be made public, will make it much easier to introduce new cosmetic ingredients in China (6) and significantly reduce animal testing. AUREA gTOXXs for standardized, easy to operate and animal-free DNA-based risk assessment is an optimal alternative for rapid screening of gene toxicity regardless of the nature of the chemicals, botanicals or nanoparticles particularly in the early phase of drug development. New potential drug agents, dietary supplements or cosmetics ingredients are equally suitable for risk assessment by AUREA gTOXXs.

AUREA gTOXXs solution for the modern product quality control
Rapid and automated solution with sizable sample throughput at the forefront of quality control AUREA gTOXXs assesses DNA integrity automatically, fast and with sizable sample throughput, ideally suited for the early stages of product development, but also for R & D in pharmaceutical, medical or biotechnology. The gTOXXs solution is a robust and easy to handle unique DNA strand break and DNA repair testing platform without the necessity for excessive training. Automated rapid sample processing and multiple replicates (96 well plate format), result in a reliable process comparable to established DNA-based tests.

The AUREA solution crests to the forefront of modern product quality control by demonstrating the applicability of the best liver model cell line (HepaRGTM) and organotypic 3D skin model (epiCS) (7; 8). AUREA gTOXXs partakes now in the design of China’s new quality control landscape. 3T has initiated cooperation with Tegent Technology Ltd. for distribution of AUREA gTOXXs in China and Vietnam.

For further information, please visit www.aurea.solutions or directly contact Dr. Paula Braun, paula.braun@3t-analytik.de

1. Uptown S. 2017 https://www.youtube.com/watch?v=GrwFa_BYgMM

2. Moreno-Villanueva M et al. 2009. A modified and automated version of the 'Fluorimetric Detection of Alkaline DNA Unwinding' method to quantify formation and repair of DNA strand breaks. BMC Biotechnology, 9, 39.3.    Bennet CL et al. 2014. The Lancet, Oncology 15; doi:10.1016/S1470-2045(14)70365-1

Wang B and Davidson A. 2017 An overview of major reforms in China’s regulatory environment. Regulatory Rapporteur Vol 14, No 7/8.
Schuh M. 2019 Medizinprodukte international – China & Indien. https://www.reuschlaw.de/news/medizinprodukte-international-china-indien/
2019 https://www.chinalawinsight.com/2019/03/articles/investment-management/china-a-thing-of-beauty-new-regulations-coming-for-cosmetics/
Dressler D et al. 2018a. Applicability of HepaRGTM cell line for automated assessment of DNA strand breaks. SOT 57th Annual Meeting and ToxExpo, San Antonio, March 11th-15th.

Dressler D et al. 2018b. Organotypic human epidermal skin models and genotoxicity – safety assessment for dermal applications. SOT 57th Annual Meeting and ToxExpo, San Antonio, March 11th-15th.
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