In Vivo Implantation Animal Testing

In Vivo Animal Testing for Biomaterials

Bring your biomaterial from bench to body with rigorously designed, ethically conducted in vivo studies. We partner with the Division of Laboratory Animal Resources (DLAR) at Stony Brook University and other accredited animal facilities to design, review, and execute in-vivo studies aligned with your regulatory pathway. We help you demonstrate local tissue response, systemic safety, and functional performance in relevant animal models—aligned with global regulatory expectations.

When in vivo testing is appropriate

Regulators expect a risk-based biological evaluation (ISO 10993-1). Many questions can be answered with chemistry and in-vitro methods, but in vivo studies are appropriate when you need to evaluate:

• Local tissue effects at and around the implant site (ISO 10993-6).
• Systemic toxicity (acute, subacute, subchronic per ISO 10993-11) when exposure can't be fully addressed by chemistry/in-vitro data.
• Irritation & sensitization when validated non-animal methods are not applicable for your material/indication (ISO 10993-10 / 10993-23).
• Functional performance of devices and coatings (e.g., osseointegration, patency, wear debris).
• Degradation behavior in vivo for resorbable and bioactive materials.

What we test

We test a broad spectrum of biomaterials, including biodegradable polymers (PLA, PLGA, PCL), hydrogels, bioadhesives, hemostats, and wound dressings; metallic implants such as titanium alloys and nitinol stents; and ceramics like hydroxyapatite, tricalcium phosphate, and bioactive glass composites. Our expertise also covers surface treatments and coatings—drug-eluting, antimicrobial, osteoinductive, or anti-fouling—and combination products at the interface of devices, biologics, and drug delivery systems.

Study types & models

• Subcutaneous or intramuscular implantation (rodent/rabbit): local tissue response, encapsulation, degradation profiles.
• Orthopedic models (rabbit/sheep/swine): bone defect filling, screw/pin fixation, spinal, dental.
• Vascular models (rabbit/swine): stent and graft deployment, patency, thrombogenicity, endothelialization.
• Dermal & wound models (rat/swine): irritation, healing kinetics, infection control, dressing adherence.
• Soft-tissue/organ specific models: hernia meshes, adhesives, ophthalmic (as justified), urologic, GI.
• Systemic toxicity: single-dose acute; repeat-dose subacute/subchronic with clinical pathology, TK (if applicable).

Typical species

Mice, rats, rabbits, guinea pigs (for sensitization), and—when justified by anatomy/scale—mini-pigs, sheep, or swine. Species are selected based on biology, device size, and ethical considerations.

Endpoints & assessments

Our assessments span clinical, pathological, imaging, and mechanical endpoints. We monitor in-life parameters such as body weight, temperature, behavior, and wound scores, complemented by hematology and serum chemistry for systemic evaluation. Imaging modalities including radiography, micro-CT, and MRI track integration and remodeling, while gross necropsy and histopathology deliver ISO 10993-6 scoring for inflammation, fibrosis, and neovascularization. Mechanical and degradation analyses quantify strength, adhesion, mass loss, molecular weight shift, and tissue residue, ensuring a complete performance profile.

How a project runs

1. Scoping & Biological Evaluation Plan (BEP): Please let us know your map material, contact type, duration, and data gaps to the right studies.
2. Protocol design: We will rely on your expertise to build the objectives, model, sample size justification (powering), humane endpoints, statistics.
3. Ethics review & approvals: We will assist your specific IACUC submissions with refinement strategies.
4. Study execution: Our veterinarian team will take care of the implantation/dosing, in-life monitoring, interim timepoints, post-surgery assessments.
5. Terminal workup: imaging, necropsy, histology, special assays.

Data package deliverables

Your final deliverables include the approved protocol, IACUC decision, complete in-life records, pathology datasets, imaging files, and histopathology reports signed by board-certified pathologists. Biostatistical analysis and a comprehensive final report with all required raw data and results.

Ready to translate your biomaterial from concept to compliant in vivo validation? Share your device or material details, intended use, contact type, duration, and existing data. We'll design a right-sized, regulatory-aligned study plan to accelerate your path to approval.

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