Preclinical research is at the core of effective drug development. Hera BioLabs is a contract research organization (CRO) utilizing revolutionary gene editing technologies to create improved preclinical models. Combining these transformative models with toxicology and efficacy studies to produce high-confidence, translational data; is what we call Precision Toxicology™ & Screening.

Both the FDA and EPA, through their integral involvement in the TOX21 collaboration are invested in the modernization and transformation of toxicology and efficacy testing by encouraging less reliance on traditional animal models and the development of alternative models that are mechanism based, provide higher through-put and are of greater clinical relevance. To this end, Hera has successfully developed several fully severe combined immunodeficient (SCID) rat lines with applications in tumor cell line xenografts and patient derived xenograft (PDX) efficacy screening, allowing our clients to achieve accurate results.  Furthermore, the humanization of the liver and immune system in Hera’s rat models is also underway, which is expected to revolutionize human specific liver toxicity screening, the availability of human hepatocytes, and the industry’s ability to test for human specific metabolites.

News & Events

Lexington based toxicology lab, Hera BioLabs, partners with the NIH to use firefly proteins for drug discovery research

Hera BioLabs, a Lexington based contract research organization (CRO), announced today a patent license and Cooperative Research and Development Agreement (CRADA) with the National Center for Advancing Translational Sciences (NCATS). The agreement is centered around a technology that uses a protein from fireflies called Luciferase, to image the activity of drugs and other chemicals in biological systems such as cell [...]

Hera BioLabs, Inc. licenses SH-SY5Y neuroblastoma cell line and introduced neurotoxicity services

Lexington, KY - February 25, 2016 – Hera BioLabs, Inc. (Hera), a privately-held toxicology contract research organization (CRO), announces the licensing of the SH-SY5Y neuroblastoma cell line, developed at Memorial Sloan Kettering Cancer Center (MSK).  Hera will apply its genome editing technologies to develop Precision Toxicology™ SH-SY5Y cell models and services. The new precisely engineered cell models will be used [...]

Hera to exhibit and present at the 2016 SOT ToxExpo

Hera will be located at booth 1103 of the SOT ToxExpo in New Orleans March 14-16. Visit us to learn about utilizing gene editing to develop more predictive and high throughput in vitro and in vivo models, requiring less reliance on traditional animal models. Hera is working to develop better in vitro models of neurotoxicity, hepatotoxicity and off target hormonal effects with high throughput [...]

Studies & Applications

‘Humanized’ Mouse Detects Deadly Drug Side Effects – Humanized liver mice could have predicted liver toxicity and prevented a failed clinical trial that led to 5 patients dying for investigational hepatitis B drug known as fialuridine (FIAU). The drug caused severe lactic acidosis which was detected by the humanized mouse model employed by researchers in the publication in PLOS Medicine (download Peltz et al. PLOS Med 2014). Humanized liver mouse models could be a versatile tool to study liver toxicity and fundamental questions about metabolism and drug induced toxicity.

hNP1™ a human ES cell derived neuroprogenitor which has improved sensitivity to chemical-induced apoptosis over differentiated neurons, for use in a developmental neurotoxicity screening

Hera’s ACT 2015 Poster: GFP+ HUMAN STEM CELL DERIVED NEURONS AMENABLE TO HIGH CONTENT NEURITE OUTGROWTH AND HIGH THROUGHPUT TOXICOLOGY ASSAYS(download Hera’s ACT 2015 Poster)

Abstract:
High throughput (HTS) and high content screening (HCS) assays often utilize primary or stem cell sources, which are not amenable to large-scale screening and can require extensive cell culture and processing prior to imaging. Our goal was to develop GFP+ human stem cell derived neural progenitors to provide a scalable solution to the previously labor intensive, single-end-point, and hence limited nature of discovery and toxicology assays, while preserving the breadth and quality of data. Human neural progenitors derived from embryonic stem cell (WiCell h9) were modified with a non-viral vector encoding a Green Fluorescent Protein (GFP) reporter gene using a selectable piggyBacTM system to produce the ArunA/Hera genetically modified hNP1GFP+TM line. Upon differentiation and selection, MAP2 expression increased to >90%, resulting in more mature neurons that exhibit significantly longer neurite length post-thaw. A cytotoxicity profile was generated for the hNP1GFP+™ human neural progenitors to ensure response to toxins, and detection and quantification under assay conditions. Cell viability and cell migration, two established neurotoxicity endpoints, were measured in cultures exposed to a panel of five compounds. A CellTiter96™ viability assay and a high throughput Cell Migration/Proliferation assay were used. hNP1GFP+™ cells exhibit detectable dose dependent response to toxins tested, (cytotoxicity and cell migration) providing a sensitive cell based human neurotox assay platform. Positive and negative controls produced results as expected, and can thus be used to normalize multi-plate data in larger screens. Overall, we conclude that hNP1™ Human Neural Progenitor Cells can be genetically modified and expanded to produce HCS and HTS assay ready cells.

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A reproducible brain tumor model established from human glioblastoma biopsies
Summary:  Xenografts of patient biopsy spheroids of glioblastoma tumors where transplanted into nude rats with a high success rate of engraftment. The larger size of the rat brain allows for easier injections and allows for other procedures and experiments which are limited in mice.
Huszthy, et al.  PLoS ONE, 2015 August.  10(8), e0136089.

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