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SenzaGen and AstraZeneca initiate technology development collaboration

SenzaGen has signed a collaboration agreement with the global biopharmaceutical  company AstraZeneca. The collaboration focuses on  testing and development of SenzaGen’s sensitization test GARDair, in order to distinguish between allergens and irritants in the respiratory tract. The goal is the validation of in vitro toxicological tests that could be applied to the discovery of new treatments for respiratory diseases without respiratory tract irritancy as a side effect.

 

The collaboration means that SenzaGen will use its leading technology platform GARD, with the help of AstraZeneca’s well-documented substance libraries, to develop a new genomic signature to distinguish allergens from irritants in the respiratory tract, something which is not possible today with in vitro methods. GARD examines and finds allergens in chemicals and medicines through a unique technology in accordance with the international 3Rs principle, Reduce, Replace and Refine, as an alternative to animal testing.

“During our research and drug discovery activities, it is important to be able to identify and mitigate potential toxicological issues as early as possible, to ensure our novel candidate drugs have the right safety profile for patients. This requires in vitro toxicological methods that are properly validated for their predictivity of clinical toxicity and that are compatible with integration into the drug discovery process. By combining SenzaGen’s technological expertise and our experience with inhaled compounds, we aim to develop a novel method to investigate whether novel drug-like molecules induce similar genomic signatures as known respiratory irritants. That could ultimately be applied to steer away from a potential irritancy hazard and enable the discovery of safer drugs for patients’” says Jorrit Hornberg, Director of Discovery Safety at AstraZeneca Gothenburg.

With this new agreement SenzaGen is initiating yet another important development collaboration with the pharmaceutical industry. SenzaGen’s focus is on introducing its tests into the pharmaceutical industry and on striving to demonstrate that there are safer and more accurate tests than those that use animals.

“This collaboration with AstraZeneca is a milestone for SenzaGen. It shows that leading pharmaceutical companies see the potential of next-generation testing and that this testing has considerable industrial value. Furthermore, the collaboration will provide SenzaGen with valuable knowledge and will help to refine and develop our GARD test for further commercial opportunities,”says Anki Malmborg Hager, CEO of SenzaGen.

The research project will run for 12 to 18 months and is in collaboration with AstraZeneca Gothenburg, contributing to the EU Horizon 2020 project granted to SenzaGen for the development of in vitro respiratory sensitization test.

 

For more information:

Anki Malmborg Hager, VD, SenzaGen AB
Email: amh@senzagen.com
Tel: +46 768 284822

 

 

About GARD
GARD is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have 90% reliability. This compares with the current predominant test method, experiments on mice, which has a reliability rating of 72%. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen
SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit www.senzagen.com.

 About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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SenzaGen introduces GARDpotency – a unique method for measuring the allergenicity of chemical substances

SenzaGen AB announces today the start of pilot sales of GARDpotency, the first animal-free method of analysis that can provide invaluable information on the allergenic potency of a chemical substance. GARDpotency is a unique complement to the previously launched test method GARDskin.

For a long time there has been huge demand from government and industry to be able to quantify the strength of chemicals’ allergenicity. SenzaGen’s new in vitro test method GARDpotency makes this possible for the first time. Quantitative information is a requirement of REACH, the EU chemicals regulation, and is of great help to companies that develop new cosmetics, pharmaceuticals and food products. Until now all testing for potency classification has been carried out on animals.

As a first step in the launch of GARDpotency, SenzaGen will present the test method for potential customers in connection with the Society of Toxicology’s annual conference 12-16 March 2017 in Baltimore, USA. The technology behind GARDpotency has been developed by a research group at Lund University. At the conference, which brings together around 6,500 toxicologists from more than 60 countries, the research team will present two scientific papers describing GARDpotency as well as new application areas for GARDskin. Summaries of the research results will soon be made available and will also be available on the SenzaGen website after the scientific publications are published.

“We see great market potential for GARDpotency. It is already possible to determine if a chemical can cause allergies, but there is a significant additional need among both manufacturers and regulatory bodies to be able to quantify how strong the allergenic effect is. Until now no animal-free testing has been available and we are extremely proud to be the first to offer this to the chemicals industry” says SenzaGen’s CEO, Anki Malmborg Hager.

GARDskin is scientifically validated and has been approved for validation in accordance with OECD requirements on allergy tests. The test provides greater than 90 percent accuracy in the classification of allergenic substances.

For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
E-mail: amh@senzagen.com
Tel: +46 768 284822

About GARD
GARD is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have 90% reliability. This compares with the current predominant test method, experiments on mice, which has a reliability rating of 72%. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen
SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA.

senzagen gard session

SenzaGen is presenting at hosted sessions at Society of Toxicology 56th Annual Meeting in Baltimore March 12-16, 2017

Lund University Scientist Andy Forreryd and SenzaGen CEO Anki Malmborg Hager will give a presentatios about the GARD assay at exhibitor hosted sessions at the Society of Toxicology 56th Annual Meeting in Baltimore, on the 13th and 14th of March.

The meeting promises more than 150 scientific sessions, approximately 350 ToxExpo exhibitors offering you the latest information on services and technology, thousands of abstract presentations, continuing education courses, awards presentations, receptions, career guidance and support, and more.

Presentations details

– Replacement of Animal Testing for CLP/GHS Classification of Skin Sensitizers is now possible using a Modified Genomic GARDskin [OECD TGP 4.106] Assay
SenzaGen presents the latest development towards reliable potency classification of chemicals according to CLP 1A and 1B, taking both LLNA and Human potency data in consideration. The assay is based on GARDskin and utilizes a refined gene expression signature developed specifically for potency categorization with high predictability.

Date: 3/13 Time: 13:30 -14:30  Room: 338

– Advantages with Genome Testing Opening up the Landscape for New Application Possibilities for Sensitization Testing using SenzaGen’s Genomic GARD Assay
SenzaGen’s GARD assay is based on expression analysis of predictive genomic biomarker signatures. Prediction calls of test substances are generated by computational methods based on machine learning. SenzaGen presents their experience in skin and respiratory sensitization testing, working with challenging compounds and mixtures, active substances, potency classification and NOEL interpretation.

Date: 3/14 Time: 13:30-14:30  Room: 338

These session are Exhibitor-Hosted Session. Although not an official part of the SOT Annual Meeting scientific program, its presentation is permitted by the Society.

Attendees are welcomed from researcher community, industry, manufacturers, regulatory agencies, consultants, CROs and every one interested in safety testing of chemical compounds.

SenzaGen presenterar på Unicorn Summit den 7 mars 2017

SenzaGens vd Anki Malmborg Hager kommer att presentera bolagets spännande utveckling vid Vator Securities Unicorn Summit den 7 mars 2017.

Presentationen kommer beskriva hur företaget kommersialiserar och vidareutvecklar sina genombaserade tester (GARD), vilka kan bedöma om kemikalier vi kommer i kontakt med i vår vardag är allergiframkallande – ett ständigt ökande problem.  Testerna bygger på hur 200 gener i mänskliga celler reagerar på det ämnen som testas, vilket innebär att de är betydligt mer tillförlitliga och ger mer information än dagens analysmetoder och kan minska behovet av försöksdjur.
– Vårt test har en tillförlitlighet på 90 procent, medan djurförsök hamnade runt 75 procent, konstaterar Anki Mamborg Hager, vd för Senzagen.

Unicorn Summit är en kapitalmarknadsdag som anordnas av Vator Sercurities för att sammanföra några av de mest innovativa och snabbväxande svenska life science-bolagen med investerare. För mer information och anmälan till arrangemanget, se www.vatorsecurities.se


För mer information:

Anki Malmborg Hager, VD, SenzaGen AB
Email: amh@senzagen.com
Tel: +46 768 284822

Om SenzaGen
SenzaGen gör det möjligt att ersätta djurförsök med genetiska tester i provrör för att bedöma om de kemikalier vi kommer i kontakt med i vår vardag är allergiframkallande. Det kan till exempel handla om kosmetika, läkemedel, livsmedel och färgämnen. Bolagets patentskyddade tester är de mest tillförlitliga på marknaden och ger mer information än traditionella utvärderingsmetoder. Testerna säljs i egen regi i Sverige och USA, och genom partners i flera andra länder. De närmaste åren kommer bolaget expandera geografiskt, knyta till sig fler distributionspartners och lansera nya, unika tester. SenzaGen har sitt huvudkontor i Lund och dotterbolag i San Francisco, USA. För mer information, besök www.senzagen.com.

Evaluation of the GARD assay in a blind Cosmetics Europe study

ALTEX Online first published February 17, 2017 https://doi.org/10.14573/altex.1701121

Johansson H., Gradin R., Forreryd A., Agemark M., Zeller K., Johansson A., Larne O., van Vliet E.,  Borrebaeck C., Lindstedt M.,

Summary

Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by animalfree testing methods, a global trend that is spreading across industries and market segments. To meet this demand, the Genomic Allergen Rapid Detection (GARD) assay was developed. GARD is a novel, cell-based assay that utilizes the innate recognition of xenobiotic substances by dendritic cells, as measured by a multivariate readout of genomic biomarkers. Following cellular stimulation, chemicals are classified as sensitizers or non-sensitizers based on induced transcriptional profiles. Recently, a number of animal-free methods were comparatively evaluated by Cosmetic Europe, using a coherent and blinded test panel of reference chemicals with human and local lymph node assay data, comprising a wide range of sensitizers and non-sensitizers. In this paper, the outcome of the GARD assay is presented. It was demonstrated that GARD is a highly functional assay with a predictive performance of 83% in this Cosmetics Europe dataset. The average accumulated predictive accuracy of GARD across independent datasets was 86%, for skin sensitization hazard. Keywords: GARD, sensitization, in vitro, predictive accuracy, alternative methods

Link to article e-pub ahead of print

 

Testing Human Skin and Respiratory Sensitizers—What Is Good Enough?

Int. J. Mol. Sci. 2017, 18(2), 241; doi:10.3390/ijms18020241

Malmborg A., Borrebaeck C. A.K.

Abstract

Alternative methods for accurate in vitro assessment of skin and respiratory sensitizers are urgently needed. Sensitization is a complex biological process that cannot be evaluated accurately using single events or biomarkers, since the information content is too restricted in these measurements. On the contrary, if the tremendous information content harbored in DNA/mRNA could be mined, most complex biological processes could be elucidated. Genomic technologies available today, including transcriptional profiling and next generation sequencing, have the power to decipher sensitization, when used in the right context. Thus, a genomic test platform has been developed, denoted the Genomic Allergen Rapid Detection (GARD) assay. Due to the high informational content of the GARD test, accurate predictions of both the skin and respiratory sensitizing capacity of chemicals, have been demonstrated. Based on a matured dendritic cell line, acting as a human-like reporter system, information about potency has also been acquired. Consequently, multiparametric diagnostic technologies are disruptive test principles that can change the way in which the next generation of alternative methods are designed.
Keywords:

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

SenzaGen awarded EU grant of € 2,4 million in heavy competition, to develop GARDair for industry use

SenzaGen has received a grant of € 2,4 million from the EU’s research and innovation framework program Horizon 2020 to develop GARDair, the first generation test for respiratory allergies.

GARDair is the first in vitro test that can detect air-borne chemicals that cause respiratory allergies, by using a unique gene technology. This follows the international 3Rs principle, Reduce, Replace and Refine, and is the first cell-based alternative to animal testing for the respiratory tract. The grant of 2,4 million Euros means that SenzaGen can develop and refine GARDair at the same time as being able to increase the pace of commercial development and the launch of another new product line. The grant runs for 24 months.

“We are incredibly delighted and proud to be part of the EU’s investment in the future, Horizon 2020. The fact that they choose to invest in 3Rs technologies shows how important this is. It is a confirmation of the potential of our technology platform, as well as a unique business opportunity to build on our product portfolio of commercially viable tests at a significantly faster rate, says Anki Malmborg”, CEO of SenzaGen.

“It is important in many different industries to be able to test the capacity of chemicals to affect the respiratory system, and today there are no tests for this. There’s a huge need for safety testing, and the grant from the EU gives us a unique opportunity together with partners from various different industries to develop the respiratory test of the future in accordance with OECD guidelines, says Henrik Johansson,” Senior Scientist at SenzaGen.

SenzaGen’s EU application has been coordinated by GAEU Consulting AB and received a exceptionally high score of 14,26 out of 15 in the EU evaluation, proving excellency both in the invention and in the application document.

 

For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
Mail: amh@senzagen.com
Tel: +46 768 284822

 

Horizon 2020 in brief
Horizon 2020 is the EU’s framework program for research and innovation. The program is the world’s largest investment in research and innovation and has a total budget of around € 80 billion (2014-2020). The aim is to ensure the EU’s global competitiveness. For more on Horizon 2020, see: https://ec.europa.eu/programmes/horizon2020/.

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SenzaGen and Bioglan working together for the next generation of test methods

SenzaGen has signed a cooperation agreement with the pharmaceutical company Bioglan, which develops and manufactures creams and ointments for the pharmaceutical and cosmetics industries. The collaboration means that Bioglan will test GARDskin for skin allergens in a number of creams that are included in various end products.

Bioglan is a pharmaceutical company that focuses on research, development and manufacture of medicines, especially semi-solids such as creams and ointments. Bioglan manufactures topical medicines and personal care products for customers within the pharmaceutical industry. The company works with everything from product development and clinical trials through to full-scale production. Safety testing and allergy testing are part of Bioglan’s everyday routine and today human skin patch tests are the preferred method of testing end products for skin allergies. SenzaGen’s GARDskin offers an alternative that may eventually replace these tests and therefore the two companies have now chosen to enter into a partnership where the use of GARDskin on complex end products will be further developed.

“With Bioglan we’ll benefit from an extensive exchange of knowledge and will have the opportunity to test GARDskin on several different formulations. We will also gain a deeper understanding of the extraction process, and can thus develop our products and processes further. Our goal is that GARDskin will work even on end products, and that more companies will therefore take note of our technology and realize that there are safer and better tests than the ones which are still routinely used in many places today,” says Anki Malmborg Hager, CEO of SenzaGen.

Bioglan, with its production in Malmö, seeks to depart from traditional testing methods on human skin and instead use the next generation’s GARD test for safety testing of the company’s products. GARDskin investigates and finds allergens in chemicals and pharmaceutical preparations through a unique genome technology that completely replaces the need for animal testing. The goal is that GARDskin should replace current tests, thus providing a better assessment of allergenicity and a more cost-effective approach.

 

For more information
Anki Malmborg Hager, CEO, SenzaGen AB                                 Birgitta Svensson, Head of Development
Email: amh@senzagen.com                                                            Email: birgitta.svensson@bioglan.se
Phone: +46 768 284822                                                                   Phone: +46 40-287561, +46 708-149354

 

About Bioglan

Bioglan AB is your partner from product development through to full-scale manufacturing. We offer a total solution for all your production and service needs. Bioglan welcomes both small and large challenges, and is your partner of choice for

  • One-off studies during product development
  • Production of material for clinical trials (phase I – III)
  • Commercial scale production for international markets

With more than twenty five years of experience in research, development and manufacturing of medicines, we can offer you all the services you need within the areas of semi-solids and liquids.

SenzaGen signs distribution agreement in Korea

SenzaGen has signed a distribution agreement with the Korean company WOOJUNG BSC, Inc.  Korea passed a legislation to ban animal testing of cosmetics on December 2015, which will be effective on February 4, 2017. With this new agreement, SenzaGen will enter one of the world’s most exciting markets and WOOJUNG BSC will market GARDskin for the field of cosmetics in Korea.

“Collaborating with new strong partners is an integral part of our business model. The agreement with WOOJUNG BSC means that we will be present in one of the most important Asian markets. Korea, just as India, has imposed a ban on animal testing on cosmetics. WOOJUNG BSC has a wide network of customers and partners in the life science sector, and also the company has been offering various solutions to the pharmaceutical GMP market and preclinical CRO services. This provides long-term benefits to our product portfolio and SenzaGen, says Anki Malmborg Hager,” CEO of SenzaGen.

Korean company WOOJUNG BSC was established in 1989 and is one of the leading research facilities in Korea. Customers include universities, pharmaceutical companies and research institutes, to which WOOJUNG BSC provides services.

“We offer a range of services to leading cosmetic and pharmaceutical companies and universities in Korea and with GARD we will expand and strengthen our offer. With the new legislation, we see that more and more of our customers will demand animal-free tests and with GARD, we get a safer and better test. It benefits us, our customers and all consumers, says Benjamin, ByungNyun Chun,” CEO at WOOJUNG BSC.

Since 2013, animal testing of cosmetic products is banned in the EU. Norway has decided to impose the same ban as the EU, while India, Israel, New Zealand and Turkey have introduced bans on carrying out animal testing for cosmetics in the country. In December 2015, Korea passed a similar ban which will come into effect in 2017. More bans are underway in major markets in the coming years, which provides an increasing demand for SenzaGens animal-free genomic testing.

 

For more information:
Anki Malmborg Hager, CEO, SenzaGen AB
E-mail: amh@senzagen.com
Phone: +46 768 284822

 

About WOOJUNG BSC
Connecting Life, Science and Research

For the last 26 years WOOJUNG BSC has been a class-leading-pioneer for the development field of animal laboratory facility and research. Providing safest and most efficient solution to the laboratory and animal researching environment, have been built many top quality laboratories and providing research solutions such as in vitro, in vivo contract research. The company is confident that cutting edge facilities constructed under WOOJUNG BSC’s name is the most beneficial for the each component of world; human, animal and environment. Scientists and researchers can be always assured that they are in SAFE SHELTER (WOOJUNG).