MFN News Items Archive | Page 38 of 44

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

26 October, 2016

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, Bioglan AB
Email: amh@senzagen.com                                                           Email: birgitta.svensson@bioglan.se
Phone: +46 768 284822                                                                 Phone: +46 40-287561, +46 708-149354

SenzaGen tecknar distributionsavtal i Korea

19 October, 2016

SenzaGens har tecknat distributionsavtal med koreanska WOOJUNG BSC, Inc. I december 2015 lagstiftade Korea om att förbjuda djurtester på kosmetika, vilket träder i kraft 4 februari 2017. Avtalet innebär att SenzaGen nu gör inträde på en av världens mest spännande marknader och WOOJUNG BSC kommer att marknadsföra GARDskin för kosmetika i Korea.

Att knyta till oss nya och starka partners är en del av vår affärsmodell. Avtalet med WOOJUNG BSC innebär att vi finns på plats på en av de viktigaste asiatiska marknaderna. Korea har precis som Indien infört förbud mot djurtester på kosmetika. WOOJUNG BSC har ett brett nätverk av kunder och partners inom life science och erbjuder olika lösningar till läkemedelsbranschen vad gäller GMP och prekliniska CRO-tjänster. Detta gynnar oss och vår produktportfölj på lång sikt, säger Anki Malmborg Hager, VD på SenzaGen.

Koreanska WOOJUNG BSC etablerades 1989 och är en av de ledande forskningsfaciliteterna i Korea. Bland kunderna återfinns universitet, läkemedelsföretag och forskningsinstitut, till vilka WOOJUNG erbjuder olika tjänster.

– Vi erbjuder en rad olika tjänster till ledande kosmetik- och läkemedelsföretag och universitet i Korea och med GARD förstärker vi vårt erbjudande. Med ny lagstiftning ser vi att allt fler av våra kunder kommer att efterfråga djurfria tester och med GARD får vi ett säkrare och bättre test. Det gynnar oss, våra kunder och alla konsumenter, säger Benjamin ByungNyun Chun, VD på WOOJUNG BSC.

Sedan 2013 råder förbud mot djurförsök på kosmetiska produkter inom EU. Norge har valt att införa samma förbud som EU, medan Indien, Israel, Nya Zeeland och Turkiet har infört förbud mot att utföra kosmetikatester på djur i landet. I december 2015 lagstiftade Korea om ett liknande förbud som träder i kraft 2017. Fler förbud är på gång på stora marknader de närmaste åren, vilket ökar efterfrågan på SenzaGens djurfria genomtester.

SenzaGen signs distribution agreement in Korea

19 October, 2016

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.

SenzaGen inbjuden till prestigefyllda ICCVAM i USA

27 September, 2016

SenzaGen medverkar idag tisdagen den 27 september på kommittémöte inom den amerikanska organisationen ICCVAM*, som främjar utvecklingen av alternativa testmetoder som ersätter djurförsök. Tillsammans med bolagets USA-partner, Burleson Technologies, medverkar SenzaGen i det officiella programmet och gör ett uttalande om Skin Sensitization Testing, vikten av säkra och robusta test för klassificering av olika substanser och därmed möjligheten att identifiera till vilken grad en substans orsakar allergi, den s.k. potencyn.

Amerikanska ICCVAM är en permanent kommitté som består av företrädare från 15 federala regulatoriska och forskningsorgan som utvärderar forskningen kring och driver utvecklingen av toxikologiska och säkerhetstester som ersätter djurförsök. ICCVAM tar expertråd från SACATM**, vars medlemmar inkluderar intressenter från reglerade branscher, djurskyddsorganisationer, akademi, amerikansk delstats- eller internationella tillsynsmyndigheter, och företag eller organisationer som utvecklar, marknadsför eller använder olika testmetoder.

I samband med SACATM blev SenzaGen inbjuden att tillsammans med sin partner Burleson Technologies göra ett uttalande under programpunkten Skin Sensitization Testing.

– Det är en stor framgång för oss att vi tillsammans med vår partner Burleson Technologies får ge vår syn på framtidens utveckling i USA, och inte minst att presentera GARD, inför medlemmarna i det prestigefyllda SACATM. Detta visar att GARD redan finns med på deras radar, som nästa generations test. Bara genom samarbete och påverkan på högsta nivå kan vi sätta en ny industristandard för allergitester på den amerikanska marknaden, säger Anki Malmborg Hager, VD på SenzaGen.

ICCVAMs möte äger rum i Raleigh i North Carolina idag tisdagen den 27 september och SenzaGens VD Anki Malmborg Hager gör sitt uttalande och ger rekommendationerna under programpunkten ICCVAM Roadmap to Skin Sensitization Testing kl. 11.25

*ICCVAM: The Interagency Coordinating Committee on the Validation of Alternative Methods

**SACATM: Scientific Advisory Committee on Alternative Toxicological Methods

SenzaGen invited to prestigious meeting at ICCVAM, US

27 September, 2016

On Tuesday the 27 September SenzaGen is invited to participate at a science Committee Meeting of the American organization ICCVAM *, which promotes the development of alternative methods to replace animal testing. Together with its US partner, Burleson Research Technologies, Inc., SenzaGen will participate in the official program and make a statement about Skin Sensitization Testing, the importance of secure and robust tests for classification of chemical substances with the ability to identify the potential of a substance causing allergy.

US ICCVAM is a permanent committee consisting of representatives from 15 federal regulatory and research agencies that requires, uses, generates, or disseminates toxicological and safety testing information to replace animal experiments. ICCVAM take expert advice from SACATM **, whose members include stakeholders from regulated industries, animal welfare organizations, academia, U.S. state or international regulatory bodies, and companies or organizations that develop, market or use test methods.

In connection with the SACATM meeting SenzaGen was invited together with their partner Burleson Research Technologies to make a statement in the session for Skin Sensitization Testing.

– It is a great achievement for us that we now have the opportunity, together with our partner Burleson Research Technologies, to give our views on the future development of testing in the U.S and to present GARD, before members of the prestigious SACATM. This shows that GARD is already on their radar, as the next-generation of sensitization testing. Only by cooperating at the highest level can we set a new industry standard for allergy testing in the US market, says Anki Malmborg Hager, CEO of SenzaGen.

The ICCVAM meeting is being held in Research Triangle Park, North Carolina on Tuesday, 27 September and the CEO of SenzaGen AB, Anki Malmborg Hager will make her statement and give the recommendations in the session ICCVAM Roadmap to Skin Sensitization Testing at 11.25 am (EDT).

* ICCVAM: The Interagency Coordinating Committee on the Validation of Alternative Methods
** SACATM: Scientific Advisory Committee on Alternative Toxicological Methods

SenzaGen tecknar sitt första distributionsavtal med brittiska XCellR8, en ledare inom djurfria tester

22 September, 2016

I linje med SenzaGens långsiktiga strategi och affärsmodell har bolaget nu tecknat sitt första distributionsavtal med brittiska XCellR8. Avtalet konfirmerar intresset av SenzaGens teknologi och öppnar upp för nya affärsmöjligheter, då XCellR8 aktivt kommer att marknadsföra GARDskin globalt för kosmetikabranschen och för producenter av hygienartiklar och hushållsprodukter och dess ingrediensleverantörer.

– Avtalet är viktigt för oss, inte enbart för att vi nu ser att vi kan leverera på vår affärsmodell, utan vi ser också ett ökat intresse för vår teknologi och vi får tillgång till en ny marknad med en väletablerad och ytterst kompetent partner. XCellR8 är en av branschens främsta ambassadörer för djurfria tester, säger Anki Malmborg Hager, VD på SenzaGen.

Brittiska XCellR8 etablerades 2008 med uppdraget och visionen att ersätta djurtester med alternativa metoder som är både etiska och vetenskapligt avancerade. Företaget samarbetar med en rad globalt ledande kosmetikabolag och deras leverantörer. XCellR8 är nu ett väletablerat och välrenommerat företag inom in vitro tester och alternativa metoder för testning av produktsäkerhet.

– Med GARD tar vi ett steg in i framtiden. Med genom-baserade metoder går vi mot säkrare och bättre tester, och på sikt även mer pålitliga konsumentprodukter utan att behöva genomföra djurtester, säger Dr Carol Treasure, VD på XcellR8

Om XCellR8
XCellR8 erbjuder djurfria testlösningar för kundföretag som erbjuder produkter inom kosmetika, hygienartiklar och hushållsprodukter och deras ingrediensleverantörer. Bolaget hjälper kundföretag att utveckla säkra och innovativa nya produkter, att följa lagstiftning, och att välja djurfria testmetoder som är både vetenskapligt avancerade och etiska.

XCellR8´s brittiska laboratorium är ackrediterat enligt GLP (Good Laboratory Practice), vilket innebär att bolaget kan erbjuda kunder testresultat som kan användas enligt regulatoriska föreskrifter för att visa produktsäkerheten.

XCellR8 är proaktiva och bidrar i det globala engagemanget för att ersätta djurförsök genom forskning och utbildningsprogram.

Om GARD
Genom att analysera 200 respektive 389 markörer beroende på test, genererar GARD stora mängder data och levererar resultat med 90 % tillförlitlighet. Detta kan jämföras med den gyllene standarden som är djurtester på möss som ger endast 72 % tillförlitlighet. SenzaGens test har därtill förmågan att mäta potensen (styrkan) av en substans och kan därmed avgöra till vilken grad en substans orsakar allergi.

Om SenzaGen
SenzaGen erbjuder in vitro-tester för hud och luftvägar till kosmetisk, kemisk och farmaceutisk industri som ersätter behovet av djurförsök. Bolagets unika test GARD är baserat på forskning från Institutionen för Immunteknologi vid Lunds Tekniska Högskola. SenzaGen är baserat på Medicon Village i Lund, Sverige.

SenzaGen signs its first distribution agreement with British XCellR8, a leader in animal-free testing

22 September, 2016

In line with SenzaGen’s long-term strategy and business model, the company has now signed its first distribution agreement with the British test lab company XCellR8. The agreement confirms the interest in SenzaGen’s technology and opens up new business opportunities as XCellR8 will actively market the GARDskin for cosmetics, personal care and household products and their ingredient suppliers globally.

– This agreement is important for us, not only because we now see that our business model works, we also see that there is an increased interest in our technology and we get access to a new market with a well-established and highly competent and renowned partner. XCellR8 is one of the industry's foremost ambassadors of non-animal tests, says Anki Malmborg Hager, CEO of SenzaGen.

XCellR8 was established in 2008 with a mission to replace animal testing with methods that are both scientifically advanced and ethically sound. The company works with a number of leading global cosmetic companies and their ingredient suppliers, and has become the “go-to” laboratory for in vitro testing expertise for both product safety and efficacy / claim support.

– By working with GARD we take a step into the future. With the use of genomics based testing we are moving towards safer and better tests, and ultimately more reliable consumer products without the need for animal testing, says Dr Carol Treasure, CEO of XCellR8

About XCellR8
XcellR8 offers animal-free testing for companies with products on the cosmetic, personal care and household product market and their ingredients suppliers. The company helps customers develop safe and innovative new products, to follow the law, and to choose non-animal test methods that are both scientifically advanced and ethical.

XCellR8 's British laboratory is accredited according to GLP standard (Good Laboratory Practice), which means that the company can offer their customers test results that can be used according to regulatory requirements to prove product safety.

XCellR8 are proactive and contributing to the global commitment to replace animal testing through research and education programs.

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 gold standard, animal tests in 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 Immunotechnology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.

SenzaGen Invited to High-Tech Health Research Expo in Washington, D.C.

14 September, 2016

SenzaGen have been invited by U.S. Representative Tom Marino to present the company's technology at the High-Tech Health Research Expo in Washington, D.C., where SenzaGen will meet US congressmen and federal procurement officials interested in the use of high-tech human-focused methods to replace animal tests. The Expo takes place on September 15th, 2016.

The High-Tech Health Research Expo is organized by U.S. Representative Tom Marino who has been an outspoken leader for increased investments in this sector of the healthcare industry. The market for alternative and animal-free test methods is growing rapidly and there is a great interest for its benefits – scientifically and economically as well as from a public health perspective.

– The provisions to reduce animal testing under the reformed Toxic Substances Control Act (TSCA) will ensure an even bigger interest in the field and SenzaGen has a natural fit in this with its test being validated for the international market by OECD says Brian Rogers, CEO of SenzaGen Inc.

At the Expo, selected companies will have the opportunity to present their technologies to Members of congress, congressional staffers and other representatives from different government agencies. The goal of the Expo is to help advance this sector of the healthcare industry by creating an opportunity for the best and the brightest in the field to efficiently reach the largest number of decision-makers at once.

– We are very proud to participate. Now, our US subsidiary will have the opportunity to reach out to some of the most influential members of Congress, who really have a say in our industry. We see it as a confirmation of our US investment and our unique test method GARD says Anki Malmborg-Hager, CEO of SenzaGen Sweden.

High-Tech Health Care Expo takes place at the Cannon House Office Building in Washington, DC on September 15, 2016. SenzaGen will participate with their U.S: employees, and will have a stand where the company will demonstrate the latest technique to replace animal testing when performing allergy testing of chemicals and chemical ingredients.

SenzaGen inbjudna till High-Tech mässa i amerikanska kongressen

14 September, 2016

SenzaGen har bjudits in av den amerikanske kongressmannen Tom Marino att presentera företagets teknologi på High-Tech Health Research Expo i Washington, DC. Där kommer SenzaGen att möta amerikanska kongressledamöter och federala upphandlingstjänstemän som är intresserade av tekniker som ersätter djurförsök. Mässan äger rum den 15 september 2016.

High-Tech Health Research Expo arrangeras av Tom Marino, som är republikansk ledamot för Pennsylvania i USA:s representanthus, och en stark förespråkare för ökade investeringar i alternativa djurfria testmetoder. Marknaden för alternativa och djurfria testmetoder växer snabbt och det finns ett stort intresse för dess fördelar – vetenskapligt och ekonomiskt såväl som ur ett folkhälsoperspektiv.

– Uppdraget att minska antalet djurförsök i och med den reformerade Toxic Substances Control Act (TSCA) säkerställer ett ännu större intresse inom området för djurfria testmetoder. SenzaGen har en naturlig plats i detta med sitt GARD test som just nu valideras av OECD för den internationella marknaden, säger Brian Rogers, VD för SenzaGen Inc.

På mässan kommer utvalda företag ha möjlighet att presentera sin verksamhet och teknik till medlemmar av kongressen samt ett stort antal viktiga beslutsfattare och upphandlare från olika myndigheter. Målet med mässan är att bidra till att öka intresset och kunskaperna kring metoder som ersätter djurförsök genom att skapa en möjlighet att lyfta de främsta företagen på området så att de på ett effektivt sätt kan nå ett stort antal beslutsfattare på en gång.

‒ Vi är mycket stolta över att få medverka. Nu har vår amerikanska verksamhet möjlighet att nå några av de mest inflytelserika kongressledamöter som har mycket att säga till om i vår bransch. Vi ser det som en bekräftelse på vår amerikanska satsning och vår unika testmetod GARD säger Anki Malmborg-Hager, VD på SenzaGen AB.

High-Tech Health Care Expo äger rum på Cannon House Office Building i Washington, DC den 15 september, 2016. SenzaGen deltar med sina amerikanska medarbetare med en monter där företaget kommer att visa den senaste tekniken för att ersätta djurförsök vid säkerhets- och allergitestning av kemikalier och kemiska ingredienser.

SenzaGen initiates cooperation with partners in Europe and the US

9 June, 2016

The final and most important step in SenzaGen's formal validation process of the sensitization test GARD has now commenced through partnerships with two external laboratories, Eurofins (Germany) and Burleson (USA). These partners will now verify GARD's reliability and reproducibility, which will allow the test to be carried out by external contract laboratories.

In this Ring TrialSenzaGen's partners, Eurofins BioPharma Product Testing in Germany and Burleson Research Technologies in the US, will be provided with a number of encoded chemicals to be tested with GARD. The verification of GARD as a robust and reproducible test will open up a new market for SenzaGen, at the same time confirming GARD's unique characteristics.

"With the validation and verification of GARD as a robust test, we can now promote GARD on a broad front in our priority sectors," says Anki Malmborg Hager, CEO of SenzaGen.

GARD has previously undergone both scientific and industrial validation. The test method, which is based on an innovative genomic technology, offers an alternative to existing tests at a time when animal testing is increasingly prohibited.

"With a successful Ring Trial we and our existing customers will have further confirmation of GARD's quality and efficiency, and it will open up new opportunities for us, not least from a regulatory perspective," says Anki Malmborg Hager, CEO of SenzaGen.

The current validation by Eurofins and Burleson will run during the fall and then be reported to EURL ECVAM for review and approval. The result of the validation will provide additional and enhanced opportunities to introduce GARD at various contract laboratories, thus providing increased market penetration.

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 gold standard, animal tests in 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 Immuno Technology at Lund University. SenzaGen is based at Medicon Village in Lund, Sweden.

About Eurofins BioPharma Product Testing, Munich
Eurofins is one of the world's largest laboratory groups with over 23,000 employees in 39 countries and more than 225 laboratories worldwide. The company offers comprehensive service that include testing of drug substance, final product, intermediates, and starting materials for both small and large molecule drug products as well as chemical and microbiological analyses in agriculture, food and environment.

About Buleson Research Technologies
Burleson Research Technologies (BRT) is a Contract Research Organization (CRO) in North Carolina that provides laboratory services to clients from the biotechnology, pharmaceutical, chemical manufacturing, government, and healthcare industries with proof-of-concept, preclinical, and clinical immunotoxicology studies.