Safety Assessment Services
With 130 animal rooms and occupying 18,000 m² of laboratory space, Charles River’s AAALAC-accredited facility in Lyon, France, conducts in vivo safety assessment by both routine and non-standard routes of administration. In addition, we offer full support in pathology and lab sciences with an increased focus on immunology and large molecules. Our Lyon site is home to both Research Models and Services (RMS) and Safety Assessment (SA), offering a unique advantage in the CRO industry in animal supplying for developmental and reproductive toxicology (DART) and juvenile studies.
For your drug development, the Scientific Advisory Services group (SAS) will help with specific questions on your study design and drug development project. An innovation group is available to listen to your needs and anticipate developments in our industry. In addition, the Lyon site is preparing to launch BSL2 capabilities specific to rodent safety assessment studies.
General Toxicology Acute to Chronic Toxicology
Offering the full range of standard rodent and nonrodent models, the expert general toxicologists at our Lyon facility design and conduct both standalone studies and expertise as well as full development programs. Standard study designs, such as single dose, sub chronic, chronic, and carcinogenicity (including TgRasH2) are available.
Our Lyon site uses the following non-standard routes:
• Continuous/intermittent intravenous infusion, using ambulatory pumps
• Subcutaneous infusion
• Intravitreal
• Intrathecal/intracerebral
• Intraarticular
• Intranasal
• Intravesical
• Intradermal and dermal, including wound healing
The staff at our Lyon site has specific and extensive experience in:
Intravenous Infusion
Charles River offers both intermittent and continuous infusion models for both rodent and nonrodent species. Our vast infusion experience and cutting-edge infusion technology ensure high quality to your most complex and challenging study designs. Our experts in surgery continuously improve their techniques to meet your requirements. Thanks to our experience, we can conduct continuous and intermittent intravenous infusion from rat, in reproductive toxicology studies, in pre- and post-juvenile studies.
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Vaccine
Charles River has comprehensive experience in conducting developmental toxicity as well as local and repeated dose toxicity studies in rabbits, rats, and mice.
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Cell and Gene Therapy
Charles River is a single service provider for in vivo studies and Laboratory Sciences (preclinical and clinical).
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Developmental and Reproductive Toxicology (DART)
Charles River provides overall DART program planning (embryo-fetal, fertility, pre- and post-natal developmental, and juvenile studies) along with individual study designs to conduct safety assessments for your products according to internationally recognized guidelines, including ICH for pharmaceutical compounds and OECD for chemical compounds.
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Safety Pharmacology
Safety pharmacology programs can help advance drug development by investigating the potential undesirable effects of a compound on physiological functions in relation to exposure in the therapeutic range and above. As every compound is unique, it takes specialized knowledge of regulatory guidance to develop the most appropriate drug safety program.
The scientists at our facility in Lyon can customize your in vivo safety pharmacology study to address both your program and compound-specific needs or include our core safety parameters in toxicology studies as an efficient means of meeting regulatory expectations.
Studies can be conducted with most routes of administration for:
• Central nervous system
• Respiratory system
• Cardiovascular system
• Renal / urinary system
• Gastro-intestinal system
Our laboratory experts can support your toxicology study by partnering with you to develop the best translational path for your therapeutic, provide detailed regulatory expectations, and offer technical expertise in required assay formats.
Immunology
Our team can provide scientific expertise on immune system function, an up-to-date knowledge of regulatory expectations, and established immunology testing. Navigate the challenges of selecting the most appropriate immune-related endpoints by leveraging our knowledge and experience. Interested in learning more about our immunology expertise?
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Large Molecule Bioanalysis and Immunogenicity
The expert scientists at our Lyon site routinely develop or transfer, optimize, validate, and apply quantitative bioanalytical methods to measure drug and metabolite concentrations for samples in most biological fluid including plasma, serum, cerebrospinal fluid (CSF), urine, tissue, and unconventional matrices like ocular, muscle, and bile.
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Biomarkers
Our comprehensive portfolio of biomarker services covers key toxicological indications and a range of therapeutic areas, including oncology, inflammation, immunology, infectious disease, ocular disease, metabolism, and diseases of the cardiovascular, renal, respiratory, and central nervous systems. From early discovery through clinical support, our biomarker services can help you identify novel biomarkers or select, validate, qualify, and apply known biomarkers to validate a target, prove a mechanism of action, predict therapeutic efficacy, or identify potential toxicity.
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Toxicokinetic Evaluation
The expert scientists perform PK parameter calculations and interpretation in preclinical studies (general toxicology, DART, and safety pharmacology), from bioanalytical data measured in plasma, serum or other biological fluids or tissues. Their expertise area includes small and large molecules (oligonucleotides, mAb with ADA assessment).
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Clinical Pathology
A comprehensive range of specialty pathology-based services are available at our Lyon facility:
• Hematology
• Biochemistry
• Coagulation
• Urinalysis
Analytical Chemistry
Experienced analytical scientists at the Lyon facility provide support in your toxicology studies for both pharmaceutical and agrochemical compounds.
Solutions, suspension, and solid formulations include diet formulation analysis and compatibility trials.
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Laboratory Pathology Services
Anatomic Pathology
Lyon’s pathology lab can perform perfusion fixation of whole animals, genomic-specific procedures at necropsy, automated embedding using harmonized organ blocking, frozen sampling/cryostat, routine H&E staining, histochemistry, and immunohistochemistry. Our pathologists are ACVP- or ECVP-board certified and can provide standalone expertise with oligonucleotides, BiTEs, infusion studies, vaccines, wound healing, and medical devices.
Digital Pathology
Our digital pathology platform provides whole slide scanning via AT2 and GT450 scanners with remote access through e-Slide Manager software and Deciphex (Patholytix)-enabled digital peer review of GLP. By leveraging advanced digital pathology solutions, we enable seamless collaboration and peer review while streamlining the delivery of data that drives decisions.
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Your Go-to Resource for Digital Pathology Services
Designed for pathologists, researchers, and other industry professionals, this eGuide offers insights and practical tools to streamline pathology workflows and accelerate decision making.
Download Your Copy
Crops and Chemicals
For general toxicology:
• OECD 407 Repeated Dose 28-Day Oral Toxicity Study in Rodents
• OECD 408 Repeated Dose 90-Day Oral Toxicity Study in Rodents
• OECD 409 Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents
• OECD 410 Repeated Dose Dermal Toxicity: 90-Day
• OECD 411 Subchronic Dermal Toxicity: 90-Day Study
For DART, study designs available include:
• OECD 414 Rat and rabbit reproduction development toxicity
• OECD 416 Two generation reproduction
• OECD 421 (Screening) or OECD 422 (Combined) reproductive toxicology study
• OECD 426 Developmental neurotoxicity study
• OECD 443 Extended one generation reproductive toxicity study
Still have questions for our experts?
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See What Our Lyon, France Site Can Do for You
Located just outside of Lyon, our site is a large in vivo facility that offers customized and routine GLP regulatory toxicology studies covering a wide range of specialties.
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Frequently Asked Questions (FAQs) About Safety Assessment in Lyon, France
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Which regulations and accreditations are applicable to your activities?
Our preclinical facility operates in compliance with Good Laboratory Practices (GLP) and is included in the national inspection programs of monitoring authorities (ANSM, COFRAC). Our Charles River Lyon site has been successfully inspected every two years by each GLP Monitoring authority since 1985 with delivery of a GLP compliance statement (grade A for full compliance).
Charles River Lyon facility is AAALAC accredited since 2005 and also accredited for receiving, storing, and handling specific products such as controlled drugs and pathogen agents such as toxins, according to our national regulations.
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Is Charles River Lyon working with chemical and pharma companies?
Yes, we are working with a proportion of 30% chemical and 70% pharmaceutical.
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What is your expertise in large molecules?
We have equal expertise in both large and small molecule.
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What expertise do you have for non-standard routes of administration?
At Charles River Lyon we have a group of seasoned experts that are continuously focused on improving their techniques.
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What is your expertise in carcinogenicity study?
We have significantly increased the number of carcinogenicity studies we’ve conducted over the last five years.