Toxicology

Safety & Toxicology

HBI provides general toxicology studies under internationally recognized regulatory guidelines for the safety evaluation of your small molecule, biotherapeutic drug candidates or medical device. Our experienced scientific team will help you navigate through every step of your R&D program according to your company profile, stage and submission requirements.

Our diverse capabilities enable us to offer flexible, targeted solutions to meet your needs at various phases of your program. We can provide a full safety assessment solution or stand-alone services.

Our team of experts work diligently to provide high-quality data and insights to ensure the safety and efficacy of new drug candidates.

In Vivo Toxicity studies

  • Acute & repeated Toxicity Studies
  • Sub-acute & Sub-chronic Toxicity Studies
  • Chronic Toxicity Studies
  • Pharmacokinetics (PK) / Toxicokinetic (TK)
  • Biodistribution Arm/studies as part of toxicology
  • Local & systemic safety studies after Implantation 
  • Biocompatibility tests

Toxicological pathology:

  • Peer review services
  • Test Site for Histopathology evaluation
  • Micro photographing and image analysis
  • Pathologist attendance at necropsy
  • Advise for processing and trimming

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www.hbi-cro.com | הצהרת נגישות

Consulting Services for Animal Facility Maintenance / Breeding​

At HBI, we offer expert consulting services to optimize animal facility maintenance and breeding programs.

Our CEO Dr. Nati Ezov can help you with tailored solutions to enhance the efficiency, health, and welfare of laboratory animals.

We offer comprehensive assessments of facility infrastructure, including HVAC systems, biosecurity protocols, and environmental enrichment strategies, to ensure optimal conditions for animal welfare and research integrity. Additionally, we provide strategic guidance on breeding program management, genetic diversity enhancement, and reproductive health monitoring to support sustainable and successful animal colony management.

Whether you’re establishing a new facility or seeking to improve existing operations, HBI is dedicated to fostering excellence in animal care and research outcomes.

Scientific consultation

  • Positioning as a full-service, high-quality CRO specifically for preclinical research
  • Supporting clients from discovery through early clinical phases
  • Focus areas of expertise like pharmacology, toxicology, etc.
  • Commitment to scientific excellence through investments, talent, quality control
  • Emphasis on collaboration and customer service
  • End goal of providing data to clients to advance best candidates into clinics

GLP archive

HBI comprehensive Good Laboratory Practice (GLP) Archive Service, is designed to ensure the secure and organized storage of your invaluable scientific data and documentation. It is maintained to meet the stringent standards of GLP, providing a secure and controlled environment for the retention of critical records from your preclinical research studies. 

With a commitment to data integrity and compliance, our GLP Archive Service offers a systematic and traceable approach to document storage, retrieval, and maintenance. 

Whether you require the archiving of raw data, study protocols, pathology slides & blocks, fixed wet tissues, electronic data or quality control records, our service aims to safeguard your research legacy, facilitating regulatory compliance and future scientific inquiries.

Our archiving services can be provided as part of a study or as a stand-alone service.

 

Partner with us for a reliable and tailored GLP archive solution that ensures the longevity and accessibility of your vital scientific records.

Histopathology Evaluation and Reporting​

Toxicological pathology is crucial in the evaluation of potential toxic effects of substances on biological tissues and organs.

This field combines pathology and toxicology to assess adverse effects, identify target organs, and elucidate mechanisms of toxicity.

At HBI Biotech Sciences, we provide comprehensive histopathological evaluation services, offering detailed analysis to support risk assessment, regulatory approval, and the safe development of medical devices, pharmaceuticals, chemicals, and other products. Our expertise in toxicological pathology ensures thorough assessment and helps ensure human and environmental safety by identifying potential hazards before they reach the market.

Histopathology evaluation and reporting can be provided as an integral part of the study execution and report or as a stand-alone service. This service may be GLP-compliant or non-GLP as required and may include incorporation of microphotographs in accordance with FDA requirements (e.g., FDA Guidance for Industry issued on March 28, 2023 – General Considerations for Animal Studies Intended to Evaluate Medical Devices) and may include, upon request, the issue of a Histopathology Phase Report. 

Bio-products

At HBI, we offer a comprehensive range of bioproducts sourced from both laboratory and farm animals (to some extent), tailored to meet the diverse needs of our clients.

Our offerings include blood products, organs, and tissues, each meticulously collected and processed according to your specific requirements.

Whether you need whole blood, plasma, serum, or other derivatives, our expert team ensures that all blood products are handled with the highest standards of care and precision. Additionally, we provide a variety of organs and tissues, harvested and preserved to maintain their integrity and viability for your research applications. Understanding the critical importance of proper storage, we offer flexible solutions, delivering your bioproducts under various conditions—frozen, refrigerated, or ambient—based on the nature of the materials and your project needs.

Our commitment to quality and customization ensures that you receive reliable, high-quality bioproducts that support your research and development goals. 

In vivo procedures

At HBI, we specialize in performing a variety of in vivo stand-alone special procedures essential for preclinical research. Our expert team is skilled in techniques such as cannulation, splenectomy, castration, and ovariohysterectomy, among others. These procedures are critical for studying disease mechanisms, evaluating therapeutic interventions, and assessing physiological responses in animal models.

We adhere to stringent protocols and ethical standards to ensure the safety, well-being, and humane treatment of all animals involved. Whether you require a single procedure or a combination of techniques, we provide precise and reliable services tailored to meet your specific research objectives. Trust HBI to deliver exceptional results with a focus on scientific rigor and ethical animal care practices.

Ex – vivo

Ex vivo studies play a pivotal role in our research methodology, allowing us to explore the intricate details of biological processes outside the living organism. In these studies, we carefully extract tissues, cells, or organs from the organism of interest and conduct meticulous analyses in controlled laboratory settings.
Our ex vivo studies serve as a powerful tool for understanding cellular mechanisms, assessing the effects of interventions, and gaining insights that contribute to the advancement of scientific knowledge. By leveraging ex vivo methodologies, we aim to uncover valuable information that can inform and enhance our understanding of various physiological and pathological processes, ultimately contributing to the development of innovative and targeted solutions.
Ex vivo services/studies – abundant possibilities suited for customer’s needs, including establishment on site and using various species as origin. Examples:

  • Ex vivo tests on skin samples
  • Ex vivo tests on eyes
  • Ex vivo tests on blood products

Health Monitoring for Laboratory Animals​

Various services for live animals delivered or for samples delivered, such as:

  • Gross necropsy of animals including samples collection for bacteriology, serology, dermatophytes and parasitology, in accordance with FELASA profiles per species or according to specific requests.
  • Bacteriology testing from swabs delivered and collected from live animals
  • Serology testing from fresh or frozen samples delivered and collected from immunocompetent or immunosuppressed animals.
  • PCR testing for specific pathogens of Laboratory Animals (either from samples collected on-site or from samples delivered).
  • Sterility testing (e.g., bacterial spore test strips of bacillus stearothermophilus)

Nati Ezov, DVM

Co- Founder and CEO

Dr. Nati Ezov has co-founded Harlan Biotech Israel (known today as HBI Biotech Sciences and Harlan Laboratories) in 1995 and since 1996 he serves as the CEO of both companies. 
As an entrepreneur in the fields of biopharmaceutical research and development, Nati led HBI Biotech Sciences (HBI) from a small CRO (under global ownership) providing specific preclinical research models and services, to be the largest private Israeli CRO company that provides full designated service to meet the requirements of our clients, local and abroad. Taking advantage of the knowledge and experience gained under the different global ownerships, he pioneered with implementation of international quality standards for preclinical trials in Israel, fostering and cultivating global collaborations and partnerships to become a prominent figure in the local preclinical research arena.

Prior to the founding of HBI, Nati was Chief Animal Technician and the Chief Veterinary Officer at Bio-Technology General Ltd. (BTG), where he gained knowledge and experience in maintenance of animals’ facilities and treatment, health care and use of laboratory animals. As a worldwide expert in the field, he provided consultation to many biotechnology companies through their different preclinical and clinical R&D stages.   

Dr. Ezov was among the four veterinarians to establish the Israeli Laboratory Animal Forum (ILAF) in 1998, aimed to serve as the primary professional body in Israel, advancing the fields of laboratory animals medicine and research and the Israeli representative in the European societies.

Throughout the years, Nati has attended workshops and completed professional courses worldwide such as microsurgical procedures workshop (England), pharmacokinetics and bioavailability of drugs (Israel) and laboratory animal sciences course (the Netherland). He has collaborated with many researchers from international institutions and appears in tens of peer-reviewed scientific articles.  

Dr. Ezov holds a degree of Doctor of Veterinary Medicine (DVM) from the Hebrew University of Jerusalem (HUJI), and a M.Sc and B.Sc from the Faculty of Agriculture, HUJI. Additionally, Nati was certified as a diplomate of expertise in laboratory animal medicine from the European College of Laboratory Animal Medicine (ECLAM) and as a Veterinary Specialist in Laboratory Animal in the veterinary services by the Ministry of Agriculture in Israel.