Rodent Models
Preclinical in vivo

Welfare-led, non-GLP solutions for early pharmacological profiling and drug development.

Preclinical in vivo Rodent Models

Designing a convincing pre-IND dataset requires more than reliable protocol execution. It requires study designs built around the biology of your compound, the regulatory expectations of your programme, and the practical constraints of your timeline and budget.

Axis Bio (a QIMA Life Sciences company) brings over 12 years of preclinical CRO experience to non-GLP pharmacokinetic, dose range finding, biodistribution, and safety profiling studies in mice and rats, with scientific oversight from the study director from design through to final report.

In vivo studies are conducted in a purpose-built facility in Northern Ireland, completed in 2026, under the Animals (Scientific Procedures) Act 1986, with the 3Rs embedded at the design stage and data packages structured for downstream regulatory use.

Our Rodent Pharmacology Capabilities at a Glance

Study Types

  • PK/PD characterisation
  • Bioavailability
  • Toxicokinetics / exploratory safety
  • Dose range finding / MTD
  • Biodistribution
  • Biomarker profiling
  • Formulation and dose route comparison
  • Drug-drug interaction

Species & Models

  • Mice (all strains, including immunocompromised)
  • Rats (all strains)

Naive or tumour bearing study configurations are available.

Genetically altered (GA) mice may be bred on site.

Dosing Routes

  • Intravenous (IV)
  • Oral Gavage (PO)
  • Subcutaneous (SC)
  • Intraperitoneal (IP)
  • Intranasal (IN)
  • Intratracheal (IT)
  • Intramuscular (IM)
  • Intradermal (ID)
  • Topical application
  • Osmotic mini pump
  • Intratumoral (where relevant)

Quality & Compliance

  • ASPA 1986 (UK, Northern Ireland)
  • Home Office licensed establishment
  • >15 personal licence holders
  • AWERB-reviewed programmes
  • 3Rs-embedded study design
  • ARRIVE guideline compliant
  • Non-GLP with regulatory-aligned documentation

How We Work

Our in vivo programmes are built around the realities of early-stage drug development: studies that need to start quickly, data that needs to be scientifically robust, and a partner who can adapt quickly. A lean, single-site structure means fewer handoffs, faster decisions, and a direct line to the scientists running your study, from the first scoping call through to the final report.

Study design built by scientists, with direct communication

Your study director is your point of contact from protocol design through to the final report. There is no translation layer between your team and ours, the scientist who designs your study is the scientist who runs it. If you need to adjust a dosing schedule mid-run, interpret an unexpected result in the data, refine a study detail, or request an ad hoc update, you speak directly to the person responsible throughout the study.

Regulatory rigour without GLP overhead

Every study we run operates within the UK Home Office regulatory framework under ASPA, with welfare oversight through an AWERB and severity limits enforced at protocol level. Non-GLP does not mean unregulated, it means flexibility at the discovery stage, with scientifically defensible data structured for downstream use. Work under our project licences has helped progress over 11 novel therapeutics into clinical trials.

Flexibility to match your stage, budget, and timeline

Our studies are scoped and matched to your programme stage. Whether you’re profiling a lead candidate before formal safety spend, generating data for investor due diligence, or building pre-IND data against a regulatory deadline, study design, deliverable format, and payment milestones are structured accordingly. We have particular experience supporting spinouts and early-stage biotechs with limited runway and timelines.

Preclinical Rodent Studies and Core Services

The service modules below describe core study types applicable across therapeutic areas and compound classes. Although these studies are most often run in naïve mice, most readouts can also be integrated into our disease models to compress timelines and maximise output per study. The exception is initial dose range finding for treatments, where baseline tolerability should be established before progression into other models.

For dedicated disease model portfolios with more granularity on specific models, see our Oncology and Immunology and Inflammation pages.

PK & Bio-availability StudiesDose Finding & TolerabilityBio-distribution StudiesSafety Biomarker ProfilingFormulation & Vehicle Screening
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Pharmacokinetics and Bioavailability

Our pharmacokinetic studies characterise the concentration-time profile of your test agent following single or multiple dose administration in mice or rats, generating the exposure parameters needed to inform dosing interval, route selection, and efficacy study design.

Study designs

Serial sampling: Multiple blood samples collected from the same individual animal at defined post-dose timepoints. Provides complete individual PK profiles. Appropriate where the number of timepoints and blood volumes per sample fall within per-animal welfare limits.

Composite serial sampling: Separate groups of three (or more) animals each sampled at staggered timepoints; the concentration-time curve is reconstructed from group means. Reduces per-animal blood volumes while maintaining statistical confidence across the full profile. Standard design for toxicokinetic (TK) and tissue distribution studies with many timepoints.

Parallel sampling: Separate cohorts of animals per timepoint. Higher total animal numbers, but maximises plasma and tissue yield per animal. Used where large-volume matrices are required for downstream analysis.

Bioavailability (F%): Absolute oral bioavailability calculated from paired IV and PO arms within a single study. Provides early ADME characterisation without the overhead of a separate study.

Drug-drug interaction (DDI): Co-administration of a test agent with a second compound to assess whether PK parameters are materially altered. Study design agreed case-by-case based on the intended combination regimen and available prior PK data.

Key Parameters Reported

  • Cmax
  • Tmax
  • AUC0–t
  • AUC0–∞
  • t½
  • CL (clearance)
  • Vd (volume of distribution)
  • F% (where IV arm is included)

Bioanalysis

We conduct the complete in-life phase: compound formulation, dosing, blood and tissue collection, and sample preparation. Matrices may be processed by QIMA Life Sciences or transferred to specialist bioanalytical partners. Clients may specify bioanalytical partners if preferred; we coordinate all sample handoff and chain of custody documentation.

Blood sampling limits (ASPA, UK Home Office)
  • ≤10% total blood volume per single bleed
  • ≤15% total blood volume over any 28-day period
  • Maximum 8 blood samples per animal over the study duration.

Composite designs are used wherever the planned timepoint schedule would otherwise approach these limits for individual animals.

Dose Range Finding and Non-GLP Tolerability

Before committing to a full efficacy study, confirming that your test agent can be administered at a pharmacologically relevant dose without causing irrecoverable harm is a necessary de-risking step. We offer structured single-dose escalation for maximum tolerated dose (MTD) determination, multi-dose tolerability studies replicating intended therapeutic schedules, and route-finding designs where the clinical administration route has not yet been established.

Study designs

Single-dose escalation: Sequential dose administration starting at a sub-toxic level, escalating in defined steps until the maximum acceptable mean weight loss (~10%) is approached or a stopping criterion is met. Designed to identify the MTD with the minimum number of animals. Primary outputs: bodyweight trajectories, body condition scores, clinical observation log, gross necropsy findings at termination. In tumour-bearing animals, body condition score supplements bodyweight as a primary welfare metric, as tumour growth can mask compound-related weight loss.

Repeat-dose administration / non-GLP tolerability: Test agent administered on a defined multi-dose schedule replicating the intended therapeutic dosing regimen. Study duration and dosing frequency agreed with the client prior to initiation. Provides early characterisation of whether cumulative exposure alters the safety profile relative to single-dose findings.

Route finding: Comparative single-dose design across two or more administration routes to assess relative tolerability and, where PK matrices are collected, initial exposure differences. Appropriate where the clinical route of administration is not established or where IP or SC routes are being considered as early proof-of-concept alternatives to IV.

Standard Add-ons

  • In-life and terminal haematology (Woodley Insight V5, 23-parameter CBC)
  • In-life and terminal blood biochemistry (Woodley V-CHEM, 15-parameter, 32+ profiles)
  • Organ weights and gross necropsy observations
  • Histopathology on target organs (with proprietary digital scoring approaches)

Biodistribution

Biodistribution studies confirm whether your test agent reaches the target tissue at relevant concentrations and whether off-target organ accumulation is present. Study design, and the analytical approach required, depends on the modality of the test agent.

Small Molecules

Naïve or tumour-bearing animals are dosed and terminated at defined post-dose timepoints. Organs are isolated, homogenised, and transferred to QIMA Life Sciences analytical labs or bioanalytical partners for LC-MS/MS quantification of compound concentration in target and off-target tissues. Composite designs using three groups of three animals at staggered timepoints are often standard for tissue distribution studies, generating full concentration-time data across tissues.

Fluorescently labelled molecules can be tracked longitudinally by non-invasive in vivo imaging, using a Vilber Newton 7.0, and fluorescence can be resolved in organs ex vivo to provide orthogonal readouts of accumulation.

Biologics, ADCs, Cell Therapies, and Gene Delivery Vectors

Distribution of large molecules, cell-based therapies, and gene delivery systems often cannot be reliably tracked by LC-MS/MS alone.

In such cases, we choose from in vivo bioluminescent and fluorescent imaging and a range of ex vivo approaches (histology, qPCR, ELISA)  to assess distribution, tissue persistence, and target engagement. For example, luciferase mRNA may be used to evaluate gene delivery systems, and cell therapies may be labelled in-house prior to use, while a simple ELISA on organ homogenates can be used to economically assess a biologic.

Luciferase-expressing cell line variants are available for relevant oncology indications.

Standard Add-ons

  • Tissue-to-plasma ratio
  • Tissue Cmax
  • Tissue AUC
  • Off-target organ accumulation profile
  • Clearance kinetics from target tissue (readout method-dependent)

Safety Biomarker Profiling

Haematological and blood biochemistry profiling at study termination provides a systems-level view of compound tolerability that body weight monitoring alone cannot capture. A terminal blood panel integrated into any dose range finding, tolerability, or efficacy study adds substantive safety signal at minimal additional animal cost. With molecular endpoints layered in, the same matrices (and tissue samples) can support target engagement confirmation and translational PD biomarker development.

Haematology

  • Red cell series: RBC count, Haemoglobin, Haematocrit, MCV, MCH, MCHC, RDW, Reticulocytes
  • Platelet series: Platelet count, MPV, PDW
  • White cell series: Total WBC, 5-part differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils)

For greater resolution, flow cytometry can be used to immunophenotype populations, and functional insights may be added by intracellular cytokine staining (ICS).

Blood Biochemistry

Hepatic: ALT, AST, ALP, GGT, Total bilirubin, Total bile acids, Total protein, Albumin

Renal: Creatinine, BUN

Metabolic: Glucose, Triglycerides, Total cholesterol, Amylase, CO2

Electrolytes/minerals: Calcium, Phosphorus, Magnesium

Muscle/cardiac: Creatine kinase (CK)

Findings are often interpreted alongside bodyweight, body condition, and clinical observations to build a safety narrative and identify target organs for histopathology.

Molecular and Tissue Biomarker Techniques

  • RT-qPCR
  • Western blot
  • ELISA
  • Multiplex immunoassay
  • Flow cytometry/FACS
  • Immunohistochemistry (IHC)
  • Immunofluorescence (IF)
  • In situ hybridisation*
  • Histopathology (H&E, including digital image analysis)
  • Transcriptomics*
  • Proteomics*
  • Metabolomics*

Molecular endpoints are agreed at the study design stage; our team can advise on collection, stabilisation, and storage to ensure matrices are fit for downstream analysis.

*Samples are transferred to specialist analytical labs for these endpoints.

Formulation Support and Vehicle Screening

We can formulate client-provided test agents in-house prior to dosing, removing the logistical overhead of preparing and shipping pre-formulated test article. Formulation capability covers the standard vehicle matrix used in early-stage drug development for the most common routes and physicochemical profiles.

What We Provide
  • Formulation of the client-supplied active test agent to the agreed concentration and vehicle composition.
  • Confirmation of pH, visual appearance, and physical stability at time of use per internal SOPs.
  • Advice on vehicle selection based on compound physicochemistry, intended route, and any prior in vivo or in vitro compatibility data available.
  • Formulation comparison studies across multiple vehicles where the optimal vehicle or route profile has not yet been established (e.g., oral methylcellulose suspension vs. solutol/DMSO solution).
What We Do Not Provide

We do not synthesise compounds. All active test material must be supplied by the client or their designated chemistry or manufacturing partner.

Regulatory Framework and Animal Welfare

We operate as a UK Home Office designated establishment under the Animals (Scientific Procedures) Act 1986 (ASPA). All regulated in vivo work is authorised under named project licences held by senior scientists, each of which requires a formal harm-benefit analysis reviewed and approved before any work begins. Every individual performing a regulated procedure holds a personal licence issued by the UK Home Office, awarded only following accredited training and demonstrated competency in the specific authorised techniques.

Our team currently includes over 15 trained personal licence holders on site, with regular in-house training sessions to maintain and expand competency across the technique portfolio. The full ASPA named persons structure is maintained, these roles provide a continuous welfare oversight layer that operates independently of individual study teams.

All proposed in vivo programmes are reviewed by our Animal Welfare and Ethical Review Body (AWERB) before study initiation, providing independent scrutiny of study design, harm-benefit balance, and welfare provisions.

The 3Rs framework — Replacement, Reduction, Refinement — is applied at study design stage, not as a post-hoc compliance review. In practice: in vitro and ex vivo work is used wherever scientifically valid ahead of in vivo escalation; group sizes are statistically powered to the minimum required to generate reproducible, valid results; humane endpoints are explicitly defined per protocol and applied proactively. All studies are documented and reported to ARRIVE guidelines.

Animals are housed in a purpose-built SPF facility in individually ventilated cages (IVC), with species-appropriate social grouping, environmental enrichment, and clinical monitoring schedules specified per protocol. Animals are bred in-house, sourced from accredited UK and EU suppliers, or from specialist providers for non-standard strains. Genetically altered mice may be bred on site under a dedicated Home Office breeding protocol.

Frequently Asked Questions (FAQS)

Lead times are most often defined by the logistics of service agreement and compound provision, but our team can generally initiate a study within 2-3 weeks of first discussion provided all requirements are met.

To scope and cost a study, the team needs the compound class and intended route, the proposed dose range or any available prior in vivo or in vitro tolerance data, your target timeline and endpoints, and the regulatory milestone the dataset must support.

No pre-formulated test material is required at the scoping stage, formulation approach is agreed as part of the study design process and our team can advise and collaboratively build a proposal where study details are unknown or to be confirmed.

This page provides an overview of our rodent pharmacology services, but our preclinical capabilities extend well beyond those shown here. Most of our studies are bespoke, and we welcome opportunities to co-develop models and tailor study designs to specific research needs. Please contact our team to discuss your requirements and our broader service offering.

Compound requirements depend on dose levels, frequency of formulation, administration route, number of animals, and sampling design. We typically formulate in-house, so clients supply bulk active material, not pre-prepared dosing solutions (although this is entirely possible). The study director confirms minimum quantities during protocol development, or this can be calculated at initial proposal stage, including an overage to ensure formulation accuracy, allowing you to reserve material and manage synthesis or manufacturing timelines accordingly.

A standard study report includes: essential details from the approved protocol and any amendments, formulation notes and examples, raw data (e.g. bodyweight records), relevant clinical observation logs, haematology and biochemistry results where applicable, derived PK parameters, any other designated endpoints with statistical analyses, and an unbiased study director interpretation section. The report format and deliverables can be agreed at study initiation to match sponsor preferences or pre-IND submission requirements.

Yes. In tumour-bearing animals, serial PK blood sampling, biodistribution tissue collection, and safety biomarker panels can be integrated with tumour volume measurement and body condition scoring within a single study design, provided the combined welfare burden remains within acceptable ASPA severity limits. This generates exposure-response data without a separate standalone PK arm, and can support pharmacodynamic analyses. For available oncology disease models, including CDX, PDX, syngeneic, orthotopic, and PBMC-humanised variants, see our dedicated oncology page.

For compounds with limited prior in vivo data, the study director designs a dose escalation conservatively, with stopping criteria (bodyweight loss thresholds, clinical signs, body condition scoring endpoints) defined before work begins. Welfare observations are increased in frequency during the early post-dose window, and escalation decisions are made in real time, with clear and prompt communication to the client. Pipelines can be designed with downstream intended studies in mind, to minimise transition times between each stage.

Both are possible. Sponsors with internal protocol standards, common in larger pharma organisations where standard PK or tolerability templates govern work across CRO networks, can provide their own protocol for us to review and execute, within the constraints of project licence and ASPA requirements. For sponsors without an established protocol, the study director develops the full design from the scoping brief.

It depends on scope. Amendments that fall within the existing project licence and study remit (e.g. adjusting a dosing schedule within already-authorised parameters, adding a terminal tissue collection, or modifying a sampling timepoint) can be implemented on the study director’s authority without regulatory delay, and are implemented with a simple amendment document. Amendments that go beyond the current licence require a formal Home Office amendment before implementation and may not be possible after a study has initiated.

Not at this time. All studies within this service programme are currently non-GLP. Non-GLP status provides the design flexibility appropriate for discovery and pre-IND work, at costs and timelines commensurate with early-stage programmes. Studies are conducted under ASPA regulatory oversight with rigorous SOP-driven documentation, and data packages are structured for downstream regulatory utility. Formal GLP toxicology requirements typically apply at a later programme stage; the Axis Bio team can advise on appropriate scope and timing of GLP package initiation relative to your IND timeline. Our offerings evolve so please contact the team for updates on this capability.

Tell us your compound class, your programme stage, and your timeline. We will scope a study design around your scientific and regulatory objectives.

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