CN Bio introduces cross-species DILI services to enhance
Traditional human in vitro methods have limited capacity to accurately determine drug toxicity. Added to this, the discrepancies between these methods and in vivo animal studies make it challenging to accurately predict safety risks for humans during preclinical testing. Often, unsafe drug candidates are wrongly progressed, and potentially life-saving ones are misclassified and abandoned, ultimately impacting clinical progression. In response to growing market demand for tools that address these concerns, CN Bio has expanded the in vitro to in vivo extrapolation (IVIVE) capabilities of its established PhysioMimix ® DILI assay, adding the ability to easily compare results across human-, rat-, and dog-derived Liver-on-a-chip models. These assays offer a modernized workflow to generate predictive and actionable insights that mitigate the risk of costly, late-stage conflicting data, and reduce unnecessary animal use by providing early warning of hepatotoxicity/DILI prior to in vivo studies.
Accessible through the Company's CRS, the new offering harnesses the longstanding expertise of CN Bio's scientific team to provide detailed data analysis, optimized outcomes, and data-driven conclusions beyond what is achievable using existing in vitro models. The assay enables a broad range of longitudinal and endpoint testing for DILI-specific biomarkers from single- or repeat-dosing studies over a 14-day experimental window. This provides a more comprehensive overview of underlying mechanisms of hepatotoxicity or latent effects of drug candidates to improve IVIVE assessment and streamline clinical progression.
Dr Emily Richardson, Lead Scientist, Safety and Toxicology, CN Bio, said: 'Understanding safety risks is critical to successful drug development, however, fundamental physiological and biological differences between species can lead to inaccuracies in predictions, often causing drug candidates to be wrongfully abandoned as toxic, or worse, mistakenly classified as safe.' She added: 'Having established our DILI assay as an industry leading option to garner more valuable insights across the development pipeline, we were in an ideal position to expand its capabilities and address this crucial gap in understanding hepatotoxicity using the most commonly used animal models. Partnering with us to utilize this powerful service not only ensures robust and reliable results but also provides access to a team of Organ-on-a-chip experts, who are invested in your success; to de-risk your pipeline and move it forward with confidence.'
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
a few seconds ago
- Yahoo
This popular energy drink may accidentally contain alcohol—what parents need to know
A packaging error involving two well-known beverage brands has triggered a safety recall—and raised new concerns for parents who keep Celsius energy drinks in their homes. According to a press release from High Noon, some of its vodka seltzer was accidentally packaged in cans labeled as Celsius Astro Vibe Sparkling Blue Razz energy drinks. The mislabeled cans contain alcohol but were distributed under non-alcoholic branding, with no external indication that they include vodka. The error occurred when a shared packaging supplier mistakenly sent empty Celsius cans to High Noon, which then filled them with vodka seltzer. The affected cans were shipped out between July 21–23, 2025, and sold in Florida, Michigan, New York, Ohio, Oklahoma, South Carolina, Virginia, and Wisconsin. 'Consumption of the liquid in these cans will result in unintentional alcohol ingestion,' the press release stated. Related: 5 million backyard pools recalled after fatal child drownings—what parents need to know Why this matters to moms If you're pregnant, breastfeeding, or have teens or tweens in the house who may be grabbing a Celsius from the fridge, this recall matters. It's possible that a can meant to provide an energy boost might instead contain alcohol—with no visual clues besides the lid color and lot code. Although no injuries or illnesses have been reported so far, the FDA has been notified, and High Noon is urging anyone with the affected cans to avoid drinking them and dispose of them immediately. Unintentional alcohol consumption can have serious implications for developing babies, young children, and adolescents. According to the Centers for Disease Control and Prevention (CDC), 'There is no known safe amount of alcohol use during pregnancy or while trying to get pregnant.' How to check your cans Look carefully at both the lot number and the lid color of any Celsius Astro Vibe Sparkling Blue Razz cans in your home. Do not consume if your can has a silver lid and a lot code between: L CCB 02JL25 2:55 to L CCB 02JL25 3:11 Cans with a black lid or different lot codes are not part of the recall and are safe to consume. The affected cans may have come from High Noon Beach Variety Packs, but even individual Celsius cans could be impacted, so it's important to check all relevant products. If you find a can that matches the lot code and silver lid description, dispose of it and contact High Noon Consumer Relations for a refund at: consumerrelations@ Related: Popular nursery chair recalled for overheating hazard—here's what parents need to know What this says about food safety labeling Labeling errors like this are rare but not unheard of. According to the FDA, 'food mislabeling' is one of the most common reasons for product recalls in the U.S. A 2022 study on product recall trends found that undeclared ingredients or wrong product contents are leading causes for consumer safety alerts. For parents juggling busy routines and making quick grocery runs, it's a reminder that we deserve better transparency and safeguards—especially when the consequences could impact kids. What to do next If you've purchased a High Noon Beach Variety Pack or a Celsius Astro Vibe Sparkling Blue Razz can recently: Check the lot code and lid color immediately. Do not consume if the product matches the affected range. Email High Noon Consumer Relations at consumerrelations@ for instructions and refund details. You can also refer to the official High Noon press release for additional guidance: High Noon recall notice. Sources: High Noon announces recall of its vodka seltzer beach pack due to inclusion of CELSIUS® Astro Vibe energy drink cans. July 29, 2025. PR Newswire. About alcohol use in pregnancy. Accessed July 30, 2025. Centers for Disease Control and Prevention. FDA 101: Product recalls. May 11, 2023. U.S. Food and Drug Administration. Undeclared allergens are the leading cause of recalls in 2023. March 15, 2023. Trustwell Blog.
Business Wire
2 minutes ago
- Business Wire
Exicure Completes the Last Patient, Last Visit in Phase 2 Study of GPC-100 for Stem Cell Mobilization in Multiple Myeloma Patients Undergoing Autologous Transplant
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Exicure, Inc. (Nasdaq: XCUR), a clinical-stage biotechnology company developing therapeutics for hematologic diseases, today announced it has completed the last patient, last visit in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT). Topline results from the study are expected in the fourth quarter of 2025. The randomized, open-label, multicenter study is designed to assess whether GPC-100, a small molecule CXCR4 antagonist, can improve CD34+ hematopoietic stem cell mobilization from the bone marrow into the peripheral blood, where they can be collected via leukapheresis for use in ASCT. In data presented at ASH 2024, GPC-100 appears to be well differentiated in terms of the speed with which it mobilizes stem cells compared to currently approved stem cell mobilization treatments. Dr. Muthalagu Ramanathan, Director of the Myeloma Program and Medical Co-Director of the Blood and Marrow Transplant and CAR-T Program at U Mass Memorial Health noted that 'traditionally, patients undergoing mobilization are required to come, as an outpatient, the night before their procedure to receive the mobilization injection — a process that adds logistical challenges. The study drug GPC100 needed to be administered just 45 minutes before stem cell collection and resulted in a successful mobilization, significantly improving the patient experience. This is a true blessing for our frail myeloma patients.' In addition to multiple myeloma and a planned Phase 1 study in acute myeloid leukemia (AML) patients, the company is also in discussions for potential collaborations that would utilize GPC-100's rapid and safe mobilization of stem cells in cell and gene therapy settings. About GPC-100 GPC-100 (burixafor) is a highly selective small molecule antagonist of CXCR4, a chemokine receptor that plays a central role in retaining hematopoietic stem cells in the bone marrow niche. By blocking CXCR4, GPC-100 may enhance the mobilization of these cells into the peripheral blood for collection and use in autologous stem cell transplant (ASCT) procedures. Originally developed by GPCR Therapeutics, Inc., GPC-100 became part of Exicure's pipeline following the company's acquisition in January 2025. In addition to multiple myeloma, GPC-100 is also being considered in acute myeloid leukemia (AML) and other diseases where improved stem cell mobilization could help enable more efficient and effective treatment approaches, such as sickle cell disease, rare diseases requiring autologous transplant, and cell and gene therapy settings. About Exicure Exicure, Inc. (Nasdaq: XCUR) is a clinical-stage biotechnology company developing therapies to address key challenges in hematologic diseases. The company's lead program, GPC-100, is being evaluated for its ability to improve stem cell mobilization in multiple myeloma, sickle cell disease, and in support of cell and gene therapy. It is also being studied as a potential chemosensitizing agent in acute myeloid leukemia (AML). For more information, visit
The Hill
an hour ago
- The Hill
Sam's Club freeze dried fruit recalled over possible Listeria contamination
A recall has been issued for a popular dried fruit snack sold at Sam's Club amid concerns that the packages may be contaminated with Listeria. The snack is Member's Mark Freeze Dried Fruit Variety Pack 15-count. The U.S. Food and Drug Administration announced the recall by Doehler Dry Ingredient Solutions LLC, in a press release Thursday, noting that no illnesses had been reported yet from the possible Listeria monocytogenes exposure. According to the Food and Drug Administration (FDA), the contamination was discovered by the company during 'internal testing of their products.' The potentially affected products were distributed between July 1-25 and were sold at Sam's Club stores across the U.S. The FDA is advising people not to consume the snack if they purchased it during that window of time. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, elderly people, and those with weakened immune systems. Exposure among healthy people can lead to symptoms like fevers, nausea and abdominal pain. Health officials warn that listeria can result in miscarriages and stillbirths among pregnant women.
