Safety Assessment Services
Home to a staff of over 1,000 scientists, technicians, and support personnel, our 44-acre site near Edinburgh, UK features expansive facilities for the development of human and veterinary pharmaceuticals, industrial chemicals, agrochemicals and animal health products, including 112 animal rooms, 28 research grade glasshouses, and 120 acres of fields and paddocks.
Here, toxicologists and analytical scientists work together to streamline your programs and optimize study designs, thus maximizing your budget while mitigating risks. Continued investment in regulatory initiatives such as SEND ensures consistent, timely data submissions.
Acute to Chronic Toxicology
Access a comprehensive range of toxicity studies in all recognized laboratory animal species. Beyond the full range of routine clinical dose routes, our team has extensive experience in non-standard routes of administration and numerous established disease models.
Inhalation
Whether you’re developing pharmaceuticals, industrial chemicals, or agrochemical products, our dedicated inhalation toxicity team can assess the effects of exposure to your compound in numerous formulations, including liquids, vapors, dust, powders and UVBCs. Studies are available in rodent and nonrodent species, from single dose and sub-chronic through chronic and carcinogenic. The team is also skilled in the conduct of radiolabeled aerosol disposition studies as well as specialty neonatal, reproductive, and neurotoxicologic endpoints.
Infusion
Evaluate the efficacy and safety of your parenteral drug formulations with expert design and conduct of robust infusion studies. With decades of experience, our team can help you overcome the challenges and establish the most appropriate method, drawing from our deep knowledge of intravenous and subcutaneous infusion, external delivery systems, implantable osmotic pumps, and programmable micro-infusion pumps.
Developmental and Reproductive Toxicology (DART)
From program planning and individual study design to execution per internationally recognized guidelines like ICH and OECD, our skilled team can help you satisfy complex developmental and reproductive toxicology (DART) requirements.
Available study designs include:
• OECD 414 Prenatal Developmental Toxicity Study
• OECD 416 Two-Generation Reproduction Toxicity
• OECD 421 (Screening) or OCED 422 (Combined) Reproductive Toxicology Study
• OECD 443 Extended One Generation Reproductive Toxicity Study
• OECD 426 Developmental Neurotoxicity Study
Drug Metabolism & Pharmacokinetics
The scientists at the Edinburgh facility can design the optimal DMPK/ADME program to support your drug discovery and development needs:
• In vitro metabolism
• In vivo ADME
• Pharmacokinetics
• Mass balance
• QWBA (tissue distribution)
• Clinical metabolism support
• Biotransformation
• Metabolite profiling and transformation
In Vitro Toxicology
The in vitro scientists at Edinburgh perform a range of studies to support dermal absorption and metabolism, safety pharmacology, and respiratory toxicology. Our world-renowned experts can also leverage bespoke and innovative technologies to design and evaluate new in vitro assays.
Bioanalytical Chemistry
From early discovery and nonclinical development (where developing and refining methods in a variety of species and biological matrices is critical) to the later clinical stage challenges of sample collection, logistics and handling, and significant data management, our expert analysts leverage state-of-the-art technology to ensure a streamlined bioanalytical service that helps you make confident research decisions.
Trust our team to develop or transfer, optimize, validate, and apply quantitative bioanalytical methods to measure drug and metabolite concentrations for samples of almost any biological fluid, including both standard whole blood, plasma, serum, cerebrospinal fluid (CSF), urine, and more unconventional matrices such as liver, brain, kidney, lung, muscle and skin.
eGuide: Bioanalysis from Early-Stage to Clinical Drug Development
Accounting for modality complexity, evolving regulatory expectations, and the critical importance of upfront planning, this eGuide explains how to identify risks early and align your bioanalytical strategy with the needs of your compound, your timeline, and your team.
Learn More
Immunology and Immunotoxicology
The Edinburgh team can support you with their extensive scientific expertize on immune system function and up-to-date knowledge of regulatory expectations. We’ve implemented specific capabilities to underpin your preclinical and clinical studies:
• Flow cytometry
• Comprehensive library of validated flow cytometry panels available or can design, develop, and validate custom panels
• Immunophenotyping and receptor occupancy assays
• ELISPOT
• T-cell Dependent Antibody Response (TDAR)
• Hemolysis
• Immunogenicity
• Screening, confirmation, and titer assays
• Cell based and plate based neutralizing antibody assays (NAb)
• Cytokine Release Assay (CRA)
• Available in a variety of matrixes (e.g., human, NHP, minipig)
Analytical Chemistry
Experienced analytical scientists at the Edinburgh facility provide support for toxicology, metabolite ID and residue studies:
Formulation Analysis
• Chemical analysis of dose formulations, and inhalation chamber atmospheres
Elemental Analysis
Inductively Coupled Plasma (ICP) is the analytical technique of choice for many industries requiring elemental analysis. Analytical Chemistry Services at Charles River Edinburgh have the facilities to support a wide variety of study types utilizing Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES) and Inductively Coupled Plasma-Mass Spectrometry
(ICP-MS) techniques.
Analytical Chemistry Services can provide analytical support for the following study types at Charles River Edinburgh:
• In Vitro Sciences
• Toxicology
• Bioanalysis
• Field Trials/ Agrochemical
• Clinical
ICP analysis can support many industries for quantifiable elemental detection, including:
• Pharmaceutical API development
• Agrochemical
• Food and Beverage
• Water and Soils
Metabolite profiling and identification services
Pre-dosing
• Radiochemical purity determination and confirmation of structure by radio LC-HRMS
• Monitor compounds which lack a chromophore
• Radiochemical repurification and certification
• Keep your study on track with our rapid repurification service and avoid costly resynthesis and shipping costs/delays
• Certification of commercial formulations (AI-concentration determination) and authentic reference materials
Sample Preparation
• Sample preparation method development for animal, e-fate, and crop matrices
• Our team of experienced chemists have worked with a wide variety of biological matrices
• Extraction and characterization of bound residues
Metabolite Profiling and Identification
• Chromatography method development
• Ground up development of bespoke analytical methods to provide separation of the most challenging analytes
• Radiochromatographic profiling using the latest BetaRam radiodetectors and high throughput offline fraction collection techniques
• 2 dimensional (radio)-LC and 2 dimensional (radio)-LC-HRMS configurations
• Reduce matrix effects, retain and resolve polars from co-eluting endogenous material
• Achieve achiral separation for analytes and resolution of enantiomers in a single injection, avoiding laborious and costly sample preparation.
• Supercritical fluid chromatography coupled to UV and tandem MS/MS for polars and chiral endpoints
• Access to the very latest Orbitrap and Time-of-Flight high resolution mass spectrometers offer the best sensitivity, speed and resolution for challenging sample types.
• Isolation, enrichment and purification of metabolites from biological matrices to assist with their identification using LC-HRMS and NMR
• The latest software packages allow us to detect the lowest concentration analytes amongst background interferences for stable and radiolabelled molecules
• Access to NMR facilities through our sister CRL sites or local academic partnerships for absolute structure determination
• Metabolite derivatization, biosynthesis and electrochemistry
QPCR and ddPCR Services
To support pre-clinical and clinical studies requiring qPCR, RT-qPCR or ddPCR platforms we have a skilled team experienced in developing and validating methods to support bioanalysis, biodistribution, vector shedding and biomarker studies.
Biomarkers
Our team offers a list of validated biomarker assays (e.g., multiplex cytokine panels, hormones, kidney markers). In addition, we have experience in development and CoU validation of custom biomarker assays using a variety of different readouts to support preclinical and clinical studies.
Anatomic and Clinical Pathology
A comprehensive range of specialty, pathology-based services are available at the Edinburgh site:
• Necropsy
• Histology
• Histopathology
• Peer review
• Hematology
• Biochemistry
• Urinalysis
• Immunohistochemistry
• Coagulation
Our Edinburgh facility has been serving the testing and regulatory needs of the world’s agrochemical and biocidal companies for nearly half a century. Trust the registration of your new and existing active ingredients to the team with a proven track record for developing tailored study programs that satisfy regulatory requirements of your intended markets. With access to the full range of chemistry, in vitro and in vivo toxicology, metabolism, environmental studies, field trials, residue analysis, and human exposure studies, we can design and manage entire agrochemical programs that minimize risk and meet your milestones.
Webinar: Reducing Risk in Agrochemical Development
Bringing novel solutions to market in the agrochemical industry is a high-risk journey filled with obstacles. Learn how to minimize risk.
Watch the Webinar