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Comprehensive Study by AstraZeneca and Genentech Confirms Superiority of InSphero Human Liver Microtissues for Prediction of Drug-Induced Liver Injury

Comprehensive Study by AstraZeneca and Genentech Confirms Superiority of InSphero Human Liver Microtissues for Prediction of Drug-Induced Liver Injury

Archives of Toxicology publication reveals microtissues are twice as sensitive as 2D primary human hepatocytes (PHH) for predicting hepatotoxicity of 110 clinically defined DILI compounds. PDF Version

Schlieren, Switzerland -  June 29, 2017  In the most comprehensive evaluation of 3D spheroid hepatic cultures conducted to date, a publication co-authored by lead toxicologists and drug safety experts at AstraZeneca and Genentech revealed InSphero 3D InSight™ Human Liver Microtissues to be a more sensitive and highly specific in vitro model for predicting drug-induced liver injury (DILI) compared to 2D models. The study entitled, “Utility of spherical human liver microtissues for prediction of clinical drug-induced liver injury,” was published online Tuesday, June 13 in the journal Archives of Toxicology. Dr. William Proctor, Head of Investigative Toxicology at Genentech, and Alison Foster, Senior Scientist in the Drug Safety and Metabolism group at AstraZeneca, were co-first authors on the publication.

2D PHH assays have been the “gold-standard” model used for DILI testing, yet DILI still remains one of the leading sources for drug attrition, black box warnings, and post-market withdrawal of drugs. Thus, there is a growing need for better predictive tools to assess liver injury earlier in the drug development process. The authors note in the paper that, “3D models have shown promise in small sets of DILI compounds, but a more comprehensive retrospective study of DILI positive and negative drugs to test the predictive power of 3D models head to head with 2D PHH assays had not been performed.”

The study determined that regardless of the threshold used, “Human Liver Microtissues demonstrated increased sensitivity in identifying known hepatotoxicants versus PHH, while specificity was consistent across both assays.” Microtissues also, “outperformed PHH in correctly classifying hepatotoxicants from different pharmacological classes of molecules.” Furthermore, the authors found that 3D microtissues displayed sufficient structural and functional characteristics to warrant exploratory studies to see if novel biomarkers used in the clinic could also be detected in vitro. Findings revealed that despite each microtissue consisting of ~1000 cells, the mechanistic and exploratory hepatotoxicity biomarkers miR-122, HMGB1, and α-GST could be detected in the culture supernatants, demonstrating that, “3D liver microtissues have the potential to recapitulate in vivo findings in vitro.”

“This landmark study provides convincing, independent evidence that InSphero liver microtissues can help identify hepatotoxic drugs with greater sensitivity without sacrificing specificity, says InSphero Chief Executive Officer and Co-founder Dr. Jan Lichtenberg. “Having two of the world’s leading pharmaceutical companies collaborate to produce this thorough validation further confirms that our 3D models not only better reflect in vivo biology, but also deliver the reproducibility and scalability required to meet the early stage screening demands of large pharma. Our assay-ready 3D InSight™ models offer a cost-effective, turnkey solution that gives toxicologists greater confidence when characterizing risk in lead compound sets.”

3D InSight™ Human Liver Microtissues are a standardized primary human liver model developed by InSphero that display enhanced liver phenotype, metabolic activity, and stability over 28 days in culture, enabling long-term drug exposure studies not attainable with 2D hepatic models.

For more information about InSphero 3D InSight™ Liver Microtissues and applications, visit www.insphero.com

InSphero contacts

Dr. Randy Strube
Director of Global Marketing
Phone +1 800-779-7558 ext. 102
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Dr. Jan Lichtenberg
Chief Executive Officer and InSphero Co-founder
Phone +41 44 5150490
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About InSphero

InSphero sets the standard for in vitro testing of novel drugs in the pharmaceutical and biotechnology industry with comprehensive solutions that provide greater confidence in decision making. Its robust and highly physiologically relevant suite of 3D InSight™ Microtissues and Services are used by major pharmaceutical companies worldwide to increase efficiency in drug discovery and safety testing. InSphero patent-pending technologies and methods enable large-scale, reproducible production of scaffold-free 3D microtissues driven solely by cellular self-assembly. The company specializes in delivering assay-ready and custom 3D models derived from liver, pancreas, and tumor tissues, to provide unrivalled biological insight into liver toxicology, metabolic diseases (e.g., diabetes and liver diseases), and oncology (with a focus on immuno-oncology). All InSphero microtissues are thoroughly validated to ensure the highest quality, certified for use in a variety of assays, and shipped globally to customers in a patented, easy-to-use spheroid-optimized platform, ready for research. Field application scientists and research staff with expertise in working with 3D models help ensure efficient integration and onsite training as needed. For customers who prefer an outsourcing strategy with fast turnaround, InSphero also offers contract research services utilizing their 3D microtissue models.

InSphero 3D InSight™ solutions drive significant findings in peer-reviewed journals, through collaborative industry initiatives such as EU-ToxRisk and HeCaToS, and have gained validation in the world’s largest government institutions and pharmaceutical, chemical and cosmetics companies.

Founded in 2009, the privately held company is headquartered in Schlieren, Switzerland with subsidiaries in the United States (Brunswick, ME) and Waldshut, Germany. It has been recognized for its scientific and commercial achievements with several national and international awards.

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Liver Microtissue        Logo ohne Tagline ISGreen RGB

InSphero 3D InSight™ Liver Microtissues help drug discovery and development groups predict drug-induced liver injury (DILI) with greater confidence, providing more relevant and reliable 3-dimensional cell based models for in vitro drug safety testing.

ADA Presentations Highlight Superior Functionality of InSphero Standardized Islet Microtissues for Diabetes Drug Screening

ADA Presentations Highlight Superior Functionality of InSphero Standardized Islet Microtissues for Diabetes Drug Screening

ETH Zurich researchers present single-islet study using novel microfluidic setup to display in vivo-like temporal insulin response to high glucose. PDF Version

Schlieren, Switzerland -  June 19, 2017  InSphero AG highlighted unique advantages of its physiologically relevant 3D InSight™ Islet Microtissue Platform to drive more efficient development of anti-diabetic drugs at the American Diabetes Association 77th Scientific Sessions in San Diego, CA. Also, a pioneering study describing a microfluidic single islet perifusion platform, developed by researchers at the ETH Zurich, was presented during open and moderated poster sessions held during the conference.

Dr. Burcak Yesildag, islet product manager at InSphero and presenter of the study at ADA says, “Loss of first phase, reduction in the second phase and impairment of the oscillatory pattern of insulin secretion are characteristic features of type 2 diabetes. Therefore, study of dynamic insulin release with in vitro perifusion assays is a crucial component of pancreatic islet research. However, inherent heterogeneity in islet size and composition necessitates pooling of multiple islets for each experimental condition, which entails inefficient use of donor material and decreased experimental resolution due to uncoordinated inter-islet function.”

InSphero 3D InSight™ Islet Microtissues - uniform in size, cellular composition and function – were combined with a novel microfluidic system engineered by Dr. Andreas Hierlemann’s research group at the Swiss Federal Institute of Technology (ETH). The microfluidic system facilitates rapid glucose switches and short sampling intervals, making it possible to study dynamic insulin secretion at the single-islet level in vitro.

Says Yesildag, “ETH observed an organotypic biphasic and pulsatile secretion of insulin from our islet microtissues which was physiologically modulated by various insulin secretagogues. The results very closely mirrored the magnitude and frequency of the response seen in humans. This collaboration provides further evidence that the in vivo-like functionality of our islet model makes it a powerful new tool for islet researchers to help accelerate anti-diabetic drug development.”

3D InSight™ Islet Microtissues are a standardized primary islet model developed by InSphero that display organotypic function with an average 13-fold increase in glucose-stimulated insulin secretion (GSIS) for at least 28 days in culture.

For more information about InSphero 3D InSight™ Islet Microtissues, visit www.insphero.com or watch the video.

InSphero contacts

Dr. Randy Strube
Director of Global Marketing
Phone +1 800-779-7558 ext. 102
This email address is being protected from spambots. You need JavaScript enabled to view it.

Dr. Patrick Guye
Chief Scientific Officer
Phone +41 44 5150490
This email address is being protected from spambots. You need JavaScript enabled to view it.

 

About InSphero

InSphero sets the standard for in vitro testing of novel drugs in the pharmaceutical and biotechnology industry with comprehensive solutions that provide greater confidence in decision making. Its robust and highly physiologically relevant suite of 3D InSight™ Microtissues and Services are used by major pharmaceutical companies worldwide to increase efficiency in drug discovery and safety testing. InSphero patent-pending technologies and methods enable large-scale, reproducible production of scaffold-free 3D microtissues driven solely by cellular self-assembly. The company specializes in delivering assay-ready and custom 3D models derived from liver, pancreas, and tumor tissues, to provide unrivalled biological insight into liver toxicology, metabolic diseases (e.g., diabetes and liver diseases), and oncology (with a focus on immuno-oncology). All InSphero microtissues are thoroughly validated to ensure the highest quality, certified for use in a variety of assays, and shipped globally to customers in a patented, easy-to-use spheroid-optimized platform, ready for research. Field application scientists and research staff with expertise in working with 3D models help ensure efficient integration and onsite training as needed. For customers who prefer an outsourcing strategy with fast turnaround, InSphero also offers contract research services utilizing their 3D microtissue models.

InSphero 3D InSight™ solutions drive significant findings in peer-reviewed journals, through collaborative industry initiatives such as EU-ToxRisk and HeCaToS, and have gained validation in the world’s largest government institutions and pharmaceutical, chemical and cosmetics companies.

Founded in 2009, the privately held company is headquartered in Schlieren, Switzerland with subsidiaries in the United States (Brunswick, ME) and Waldshut, Germany. It has been recognized for its scientific and commercial achievements with several national and international awards.

Follow us on Twitter and and LinkedIn.

 

Images

Islet no background        Logo ohne Tagline ISGreen RGB

InSphero 3D InSight™ Islet Microtissues help drug discovery and development groups identify more effective drugs for diabetes by providing more relevant and reliable 3-dimensional cell based models for in vitro efficacy testing.

InSphero, AstraZeneca Islet Microtissue Work Wins Best Poster Award at EASD Islet Study Group

InSphero, AstraZeneca Islet Microtissue Work Awarded "Best Poster" at EASD Islet Study Group & Beta Cell Workshop

Schlieren, Switzerland - May 9, 2017

InSphero's Burcak Yesildag, PhD and collaborators at AstraZeneca Mölndal were announced on Tuesday, May 9th as winners of the Poster Award at the annual EASD Islet Study Group & Beta Cell Workshop, held in Dresden, Germany.  The poster, entitled "A Novel Standardized In Vitro Islet Model System for Assessment of Pancreatic β-cell Proliferation" is the second such honor for InSphero in 2017, having received the ELRIG Research & Innovation "Best Technology" Award in March for the full portfolio of advanced 3D InSight™ Microtissues for drug safety and efficacy testing.

The scientific program at the annual conference covers a wide spectrum of topics in the field of islet biology, including beta cell development, maturation and regeneration, beta cell function, genetics & epigenetics of beta cells, beta cell therapy and beta cell interaction with immune cells. Attendees include leaders in the field, rising stars as well as postdocs and students, who come together to exchange their latest findings and ideas in order to foster progress and networking in the field of islet biology.  

In addition to May presentations at the European Society for Animal Cell Technology (ESACT) in Lausanne, Switzerland and the Midwest Islet Club (Madison, WI) featuring 3D InSight™ Islet Microtissues, Dr. Yesildag will present groundbreaking work performed in collaboration with the ETH Zurich assessing islet microtissue function under perifusion conditions in a microphyisiological system (MPS) at the 77th Scientific Sessions of the American Diabetes Association (ADA) Meeting held June 9-13 in San Diego, CA.  

 

BYe

Dr. Burcak Yesildag, InSphero AG 

Islet no background

InSphero 3D InSight™ Islet Microtissues provide greater confidence to pharmaceutical drug discovery and development groups in their efforts to better assess diabetes drug efficacy and safety.

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