October 2018

Video: The 3T3 Neutral Red Uptake Phototoxicity Test

October 31, 2018
This training video explores a cell-based method for assessing Phototoxicity — or the potential for chemicals to cause damage after being exposed to light.  The method is used widely around the world by many industries, including the cosmetics and pharmaceutical sectors. Disclaimer:  Please note that the procedures shown in this video were for demonstration purposes only and that all assay procedures, except the UV A/dark exposure, should be performed in a biological safety cabinet using aseptic techniques. Due to video production reasons,...

Tobacco Companies Embracing In Vitro Toxicology

October 29, 2018
The tobacco industry is facing increased testing requirements for e-cigarettes and other tobacco products that entered the market after Feb. 15, 2007.  Companies hope in vitro tests that use human lung cells or tissues will be sufficient to show that their new tobacco products, including e-cigarettes, significantly reduce harm and disease and benefit the population as a whole when compared with traditional cigarettes.  Several of them are working with independent, third-party laboratories, including the Institute for In Vitro Sciences (IIVS),...

Non-animal Vaginal Irritation Method Admitted into the US FDA Medical Devices Development Tool (MDDT)

October 18, 2018
FDA’s recently launched Predictive Toxicology Roadmap calls for the optimization of non-animal methods for the safety evaluation of drugs, consumer products and medical devices. We have created an Industry Consortium comprised of manufacturers of personal lubricants/vaginal moisturizers and companies interested in the advancement of animal alternatives working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach that could be used in place of the rabbit vaginal irritation (RVI) in pre-market submissions....

How the Good In Vitro Method Practices Guidance Document Can Help Implement New Toxicological Approaches: A Case Study in China

October 17, 2018
Currently China is striving to adopt and implement non-animal, including in vitro, testing approaches for the safety assessment of cosmetics and ingredients.  Collaborative efforts between industry and the Institute for In Vitro Sciences (IIVS, Gaithersburg, USA) have focused on the transfer of several OECD Test Guideline methods to government laboratories in China and have supported the creation of an in vitro toxicology testing laboratory within the Zhejiang Institute for Food and Drug Control (Hangzhou, China).  Recently BASF SE (Ludwigshafen, Germany) and IIVS...

China’s Compulsory Animal Testing for Cosmetics May Take More Than Five Years to Stop

October 17, 2018
By Amanda Lim, Editor (Singapore) CosmeticsDesign-Asia.com   Although China has made significant strides in moving away from animal testing, its challenges suggest it may take more than five years for the country to completely stop compulsory animal-testing for cosmetics, says Hedy He, regulatory analyst and editor of ChemLinked: "In the short term a total ban on animal testing is unlikely given the lack of testing infrastructure and technical capacity shortcomings of the industry." The Overarching Issue Among the many obstacles, the overarching one is the...

IIVS e-News – October 2018

October 11, 2018
In this issue, learn about our appointment to a working group in China for alternatives, our collaboration with BASF and Givaudan, our presence at estiv2018 and the PCPC 2018 Science Symposium, and more.  Read issue....

Toxicologist I

October 11, 2018
We are seeking a full time Toxicologist I/Study Director to work in our Gaithersburg office. This is an exciting opportunity to join and grow with our team to contribute and share in our company vision: A day when methods based on humane, wisely applied science will be used by industry and the regulatory agencies to understand the true safety and efficacy of substances.   Specific Responsibilities Include, but are not limited to: Participate in the management of the skin sensitizer screening program. ...

IIVS Appointed to China’s Alternatives Working Group for Cosmetics

October 9, 2018
Gaithersburg, MD – October 9, 2018 – U.S. based Institute for In Vitro Sciences (IIVS) has been invited by China’s National Institute for Food and Drug Control (NIFDC) to join their working group on alternatives for cosmetics.  The newly established group was announced by the NIFDC during their 2nd International Conference on Cosmetics Alternative Methods held in Beijing in September.  Chaired by NIFDC Vice Director, Lu Yong, the working group also includes representatives from several provincial government agencies and companies...

Webinar: Precision-cut Lung Slices

October 5, 2018
Dr. Holger Behrsing, Principal Scientist with IIVS, recently presented "Precision-cut Lung Slices (PCLS)" for the 2018 PETA International Science Consortium webinar series on non-animal inhalation testing methods. ...

IIVS Hosts Quarterly Meeting for SQA’s Computer Validation and IT Compliance (CVIC) Specialty Section

October 4, 2018
The CVIC agenda included a presentation and follow-up discussion on artificial intelligence and computer learning and their use in regulated industry, a panel discussion of cloud computing adoption in “GxP” environments, and open discussion on the use of the “Internet of Things” and data integrity and governance concepts.  In addition to the CVIC member, an FDA representative was on site to gather industry input on specific topics.  IIVS is pleased to support activities like this through the Society of Quality Assurance. If...