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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 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.

GARD approved for validation within the OECD

GARD, Senzagen´s in vitro assay for sensitization, has been included in the OECD Test Guideline Programme (TGP) work plan with the TGP No  4.106. The decision was made at the WNT National Coordinators Test guideline programme meeting in the end of April. The validation process for GARD will now be initiated.

SenzaGen’s test Genomic Allergen Rapid Detection (GARD) has been reviewed by all OECD WNT (The Working Group of the National Coordinators of the Test Guidelines Programme (WNT)) task force members and has been included in the Test Guideline Programme. This means that the process of formally validating GARD can begin. The purpose of the validation process is to show that GARD is a reproducible assay that can be use by external laboratories. The assay will be transferred externally to perform a so called “ring trial”.

“This is a very important decision for the development of GARD as an international sensitization test and we are very confident we will have a successful ring trial. Even if our customers have been convinced by the quality of our test, it will make a big difference from a regulatory point of view when the test is validated”, says Anki Malmborg Hager.

The GARD test has been scientifically validated and has gone through successful in house validations prior to this with industrial partners. The test assay is based on a new innovative genomic technique which is argued to be the future of sensitization testing now that animal bans are more and more prevailing. As the chemical industry needs to find accurate and reliable tests, GARD will be an important player on the testing market once it has finalised its validation.

“The OECD WNT representatives were very interested and positive to the GARD test and to include it in the TGP work plan. The representatives also look forward to receiving information regarding the formal validation, when these results are available. The demand is high for new alternative test methods and it has been an interesting journey as a representative for Swedish Chemicals Agency (Kemikalieinspektionen) to present GARD to OECD as it has such great potential. I am very much looking forward to follow the future for this test”, says Henrik Appelgren, national coordinator at Kemikalieinspektionen.

Two external laboratories will now test GARD on several different chemicals to confirm that the test is reproducible. This process has started and final validation is expected within one year.

 

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

Brian Rogers, CEO, SenzaGen Inc
E-mail: brian.rogers@senzagen.com
Phone: +1 530 304 7648

 

About GARD
By analyzing 200 and 389 markers, depending on the test, GARD generates massive amounts of data and delivers results with 90 % prediction accuracy. This can be compared to the golden standard, animal tests on mice, that provides 72 % prediction. SenzaGen’s test also has the ability to measure potency (strength) of a substance and can thus determine the degree to which a substance is an allergen.

 

About SenzaGen
SenzaGen provides dermal and respiratory in vitro testing for the cosmetic, chemical and pharmaceutical industries replacing the need for animal testing. The company’s unique test GARD is based on research from the Department of Immune Technology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.

SenzaGen signs new customer – entry into the pharmaceutical industry

SenzaGen has signed a strategic contract with a major international pharmaceutical company. This means that SenzaGen’s test GARD will be used for the testing of drug candidates in early development. The agreement opens up a whole new market for GARD, which previously has been used primarily for testing in the cosmetics industry.

Based at Medicon Village in Lund, SenzaGen develops and implements animal-free allergy tests on chemicals and proteins. SenzaGen’s test GARD (Genomic Allergen Rapid Detection) has been developed over 15 years and measures significantly more parameters than existing tests on the market. This makes GARD a safer and more effective test than other available options.

So far, GARD has primarily been used for testing in the cosmetics industry to detect potential allergens in products, but it is now entering the pharmaceutical industry.

“Since the start, collaborations with pharmaceutical companies has been a major objective for SenzaGen. We see great potential in this market and we are looking forward to learning more about the industry, with an ambition to be able to develop and offer GARD to even more customers in the pharmaceutical industry”, says Anki Malmborg Hager, CEO SenzaGen

The main advantage of using GARD is that the test is based on genomic technology and is performed in vitro. This is the first time that a pharmaceutical customer uses SenzaGen’s method. The tests can be done in a very early phase of drug development, which helps pharmaceutical companies to develop safer drugs at faster pace and at a lower cost.

 

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

 

About SenzaGen
SenzaGen provides in vitro testing for the cosmetic, chemical and pharmaceutical industries replacing the need for animal testing. The company’s unique test GARD is based on research from the Department of Immune Technology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden and has 10 employees.

About GARD
By analyzing 200 and 389 markers, depending on the test, instead of 1-2 markers as competing methods do, GARD delivers results with 90 % prediction. This can be compared to the gold standard, animal tests on mice, that provide only 72 % prediction. SenzaGen’s test also has the ability to measure potency (strength) of a substance and can thus determine the degree to which a substance is an allergen. Existing, competing tests do not achieve sufficient specificity / sensitivity and lack the ability to measure the potency of a substance.

 

 

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SenzaGen AB, a diagnostic spin-off company from Lund University, reports the launch of a new product for respiratory sensitization testing

SenzaGen AB is a diagnostic company working to replace animal testing for sensitization predictions.

“Sensitization through the lung is a growing issue and methods to predict if a chemical has a sensitization effect are limited”, says Anki Malmborg Hager, CEO in SenzaGen. Based on extensive research about the responses of the immune system in allergic reactions, SenzaGen has now launched a test that predicts the respiratory sensitization ability of chemicals based on the GARD methodology.

An international scientific article about the underlying research has been published in PLOS ONE, under the title “Prediction of Chemical Respiratory Sensitizers Using GARD, a Novel In vitro Assay Based on a Genomic Biomarker Signature”. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118808

SenzaGen´s first product, a skin sensitization test of chemicals, is already on the market.

SenzaGen AB completes successful collaboration with Beiersdorf AG.

SenzaGen AB, a diagnostic spin-off company from Lund University, reports the successful completion of a collaboration with Beiersdorf.

SenzaGen AB, a diagnostic company working to replace animal testing, has been collaborating with Beiersdorf to evaluate its skin sensitization test for chemicals.

SenzaGen AB is based on research at the Department of Immunotechnology at Lund University, providing animal-free, in vitro sensitization tests for the cosmetic, chemical, pharmaceutical and food industries.

Beiersdorf has been working in the development and recognition of alternative methods for more than 20 years and is one of the main players in the cosmetic industry in Europe. An industry that is highly interested in recommendations in this field – especially after the ban in March 2013 on animal testing in the cosmetic industry.

“It has been very valuable for SenzaGen to be able to challenge its skin sensitization test in an industrial setting.” says Prof. Carl Borrebaeck, chairman of the board of SenzaGen.

In the collaboration, blind testing of two industrial test sets of chemicals were performed using the SenzaGen proprietary GARD assay, resulting in an accuracy of 89%.

henrik johansson senior scientist

Dr. Henrik Johansson, scientist and COO of SenzaGen AB, was awarded the LUSH Young Researcher Award 2014.

“The project for which Dr. Johansson was awarded, the Lush Prize Young Researcher Award, describes the development and use of the novel test method GARD – Genomic Allergen Rapid Detection, an assay for assessment of chemical sensitizers.

…GARD utilises an in vitro model of so-called dendritic cells, a central player in the human immune system. These cells are stimulated with any substances to be tested, and following an incubation time of 24h, the genetic material of the cells are isolated. By measurements of a certain set of genes in the cells, which could be viewed as on/off-switches of the immune response, the eventual risk of the tested substances ability to induce allergy can be predicted.” [Lush Prize Young Researcher http://www.lushprize.org/2014-prize/2014-prize-winners/]

Read more on Lush Prize Young Researcher Award web site