A new French distributor is joining us

We are proud to welcome PKDerm as GARD® distributor. Located in Grasse, France, PKDerm offers innovative in vitro solutions to pharmaceutical, dermo-cosmetic and chemical industries in order to evaluate the efficacy and safety of products likely to come into contact with the skin. “As a GARD distributor, we are excited to offer a solution to […]

We are proud to welcome PKDerm as GARD® distributor.

Located in Grasse, France, PKDerm offers innovative in vitro solutions to pharmaceutical, dermo-cosmetic and chemical industries in order to evaluate the efficacy and safety of products likely to come into contact with the skin.

“As a GARD distributor, we are excited to offer a solution to customers in various industries for their in vitro testing needs. GARD has shown impressive performance in skin sensitization, and its ability to evaluate a large variety of substances combined with potency measurement makes it truly unique. We expect the GARD assays to become an essential complement to our portfolio”, says Hanan Osman-Ponchet, PKDerm’s founder and CEO.

Hanan Osman-Ponchet, PKDerm’s founder and CEO.

Follow this link to contact PKDerm for your next or current testing project.

Welcome MB Research Labs to our partner network

We are excited to announce that another CRO has been fully trained on SenzaGen’s GARD technology platform and is offering GARDskin and GARDair services.   As a leading provider of in vitro toxicity testing to the US and worldwide, MB Research Labs is deeply committed to their customers and is dedicated to offering the latest […]

We are excited to announce that another CRO has been fully trained on SenzaGen’s GARD technology platform and is offering GARDskin and GARDair services.  

As a leading provider of in vitro toxicity testing to the US and worldwide, MB Research Labs is deeply committed to their customers and is dedicated to offering the latest predictive and innovative test methods.

We are delighted to have MB Research Laboratories in our partner network.

Dr. George DeGeorge and Dr. Michelle Cicchini of MB Research Laboratories performing the GARD assay.

MB Research Labs’ Website

Validation of the GARD™skin assay for assessment of chemical skin sensitizers – ring trial results of predictive performance and reproducibility

Toxicological Sciences, kfz108, https://doi.org/10.1093/toxsci/kfz108 Henrik Johansson, Robin Gradin, Angelica Johansson, Els Adriaens, Amber Edwards, Veronika Zuckerstätter, Anders Jerre, Florence Burleson, Helge Gehrke, Erwin Roggen Abstract Proactive identification of chemicals with skin sensitizing properties is a key toxicological endpoint within chemical safety assessment, as required by legislation for registration of chemicals. In order to meet demands of increased animal welfare and facilitate increased testing efficiency […]

Toxicological Sciences, kfz108, https://doi.org/10.1093/toxsci/kfz108

Henrik Johansson, Robin Gradin, Angelica Johansson, Els Adriaens, Amber Edwards, Veronika Zuckerstätter, Anders Jerre, Florence Burleson, Helge Gehrke, Erwin Roggen

Abstract
Proactive identification of chemicals with skin sensitizing properties is a key toxicological endpoint within chemical safety assessment, as required by legislation for registration of chemicals. In order to meet demands of increased animal welfare and facilitate increased testing efficiency also in non-regulatory settings, considerable efforts have been made to develop non-animal approaches to replace current animal testing.

Genomic Allergen Rapid Detection (GARD) is a state-of-the-art technology platform, the most advanced application of which is the assay for assessment of skin sensitizing chemicals, GARDskin. The methodology is based on a dendritic cell (DC)-like cell line, thus mimicking the mechanistic events leading to initiation and modulation of downstream immunological responses. Induced transcriptional changes are measured following exposure to test chemicals, providing a detailed evaluation of cell activation. These changes are associated with the immunological decision-making role of DCs in vivo and include among other phenotypic modifications, up-regulation of co-stimulatory molecules, induction of cellular and oxidative stress pathways and xenobiotic responses and provide a holistic readout of substance-induced DC activation.Here, results from an inter-laboratory ring trial of GARDskin, conducted in compliance with OECD guidance documents and comprising a blinded chemical test set of 28 chemicals, are summarized. The assay was found to be transferable to naïve laboratories, with an inter-laboratory reproducibility of 92.0%. The within-laboratory reproducibility ranged between 82.1-88.9%, while the cumulative predictive accuracy across the three laboratories was 93.8%.It was concluded that GARDskin is a robust and reliable method for the identification of skin sensitizing chemicals and suitable for stand-alone use or as a constituent of integrated testing. These data form the basis for the regulatory validation of GARDskin.Keywords
GARD™, GARD™skin, in vitro, sensitization, chemical sensitizers

Full article
Article on line ahead of print with open access 

Swedish influencer Margaux Dietz tests shampoo at SenzaGen

One of Sweden’s most famous influencers, Margaux Dietz, has visited SenzaGen in Lund. With support from the EU, SenzaGen has developed the world’s first animal-free test for respiratory allergies making our daily products safer. Margaux put a lab coat on and got to allergy test her own shampoo. Now, Margaux knows that the EU investments […]

One of Sweden’s most famous influencers, Margaux Dietz, has visited SenzaGen in Lund.

With support from the EU, SenzaGen has developed the world’s first animal-free test for respiratory allergies making our daily products safer. Margaux put a lab coat on and got to allergy test her own shampoo. Now, Margaux knows that the EU investments in innovations make a difference in everyday life.

Evaluation of in vitro testing strategies for hazard assessment of the skin sensitization potential of “real‐life” mixtures: the case of henna‐based hair coloring products containing p‐phenylenediamine

Wiley Online Library, First published: 21 April 2019,  https://doi.org/10.1111/cod.13294. Renato I. de Ávila Danillo F. M. C. Veloso Gabriel C. Teixeira Thaisângela L. Rodrigues Tim Lindberg Malin Lindstedt Simone G. Fonseca Eliana M. Lima Marize C. Valadares Abstract Background Allergic contact dermatitis reported to henna‐based hair coloring products (HPs) has been associated with adulteration of […]

Wiley Online Library, First published: 21 April 2019,  https://doi.org/10.1111/cod.13294.

Renato I. de Ávila Danillo F. M. C. Veloso Gabriel C. Teixeira Thaisângela L. Rodrigues Tim Lindberg Malin Lindstedt Simone G. Fonseca Eliana M. Lima Marize C. Valadares

Abstract

Background
Allergic contact dermatitis reported to henna‐based hair coloring products (HPs) has been associated with adulteration of henna with p‐phenylenediamine (PPD).

Objectives
To develop a testing approach based on in vitro techniques that address key events within the skin sensitization adverse outcome pathway to evaluate allergenic potential of HPs.

Methods
The following in vitro assays were used to test the sensitizing capacity of hair dye ingredients: micro‐direct peptide reactivity assay (mDPRA); HaCaT keratinocytes‐associated IL‐18 assay; U937 cell line activation test (USENS)/IL‐8 levels; blood monocyte‐derived dendritic cell test; genomic allergen rapid detection (GARD skin). Those techniques with better human concordance were selected to evaluate the allergenic potential of ten HPs.

Results
Contrasting to the label’s information, chromatographic analyses identified PPD in all products. The main henna biomarker, lawsone, was not detected in one of 10 the products. Among the techniques evaluated by testing HDIs, mDPRA, IL‐18 assay, GARD skin and U‐SENS correlated better with human classification (concordances 91.7 to 100%) and were superior to the animal testing (concordance 78.5%). Thus, these assays were used to evaluate HPs, which were classified as skin sensitizers using different two‐out‐of‐three approaches.

Conclusions
Our findings highlight toxicological consequences and risks associated of the undisclosed use of PPD in henna‐based “natural” “real‐life” products.

This article is protected by copyright. All rights reserved.

Our view on alternative testing for product safety in Manufacturing Chemist

To replace a test animal, which is clearly a complex system with blood and organs, you need a more holistic approach to model the entire allergic response within the body. Our CEO Anki Malmborg Hager explains the benefits of using alternative testing methods to prove product safety in this week’s Manufacturing Chemist. Read the article […]

To replace a test animal, which is clearly a complex system with blood and organs, you need a more holistic approach to model the entire allergic response within the body. Our CEO Anki Malmborg Hager explains the benefits of using alternative testing methods to prove product safety in this week’s Manufacturing Chemist.

Read the article here

Skin Sensitization Testing—What’s Next?

Int. J. Mol. Sci. 2019, 20(3), 666; https://doi.org/10.3390/ijms20030666   Gunilla Grundström and Carl A.K. Borrebaeck Abstract There is an increasing demand for alternative in vitro methods to replace animal testing, and, to succeed, new methods are required to be at least as accurate as existing in vivo tests. However, skin sensitization is a complex process […]

Int. J. Mol. Sci. 2019, 20(3), 666; https://doi.org/10.3390/ijms20030666  

Gunilla Grundström and Carl A.K. Borrebaeck

Abstract

There is an increasing demand for alternative in vitro methods to replace animal testing, and, to succeed, new methods are required to be at least as accurate as existing in vivo tests. However, skin sensitization is a complex process requiring coordinated and tightly regulated interactions between a variety of cells and molecules. Consequently, there is considerable difficulty in reproducing this level of biological complexity in vitro, and as a result the development of non-animal methods has posed a major challenge. However, with the use of a relevant biological system, the high information content of whole genome expression, and comprehensive bioinformatics, assays for most complex biological processes can be achieved. We propose that the Genomic Allergen Rapid Detection (GARD™) assay, developed to create a holistic data-driven in vitro model with high informational content, could be such an example. Based on the genomic expression of a mature human dendritic cell line and state-of-the-art machine learning techniques, GARD™ can today accurately predict skin sensitizers and correctly categorize skin sensitizing potency. Consequently, by utilizing advanced processing tools in combination with high information genomic or proteomic data, we can take the next step toward alternative methods with the same predictive accuracy as today’s in vivo methods—and beyond.

Keywords

genomics; machine learning; skin sensitization; adverse outcome pathways; next generation in vitro tests

Article online

Merry Christmas and a Happy New Year!

SenzaGens attended BioFIT in Lille, France

On December 4-5, SenzaGen was attending BioFIT in Lille, France. BioFIT is a business development meeting with focus on early stage innovations including pre-clinical stage assets. We met with CROs and life science companies from all over Europe in search of screening tools at pre-clinical stage. Read more about Biofit here: https://www.biofit-event.com

On December 4-5, SenzaGen was attending BioFIT in Lille, France. BioFIT is a business development meeting with focus on early stage innovations including pre-clinical stage assets. We met with CROs and life science companies from all over Europe in search of screening tools at pre-clinical stage. Read more about Biofit here: https://www.biofit-event.com