Pathology and Preclinical Immunology
Accelerate Preclinical Testing with Comprehensive Pathology
Get comprehensive preclinical pathology services to support your drug development, including necropsy, histology, histopathology primary reading and peer review, immunopathology, and clinical pathology. With advanced techniques and global expertise, WuXi Biology and Testing’s expert pathology team provides the detailed, high-quality data you need to accelerate preclinical testing and regulatory submission.
Global Pathology and Preclinical Immunology Services
Our preclinical pathology team brings proven experience and expediency to your toxicology testing. We evaluate 210,000+ tissues per month across a variety of animal species and can provide a solution tailored to your specific drug discovery and development needs.
- Small & large molecules (peptides/proteins/antibodies)
- Cell and gene therapies
- Expert team staffed with American College of Veterinary Pathologists & Chinese College of Veterinary Pathologists
- Expertise in multiple areas, for all types of drugs
Toxicologic Pathology
Our toxicological pathology testing provides a detailed evaluation of the effects of drugs or compounds on organ systems and tissues, helping assess potential toxicities, detect adverse reactions, and identify target organs for toxicity.
- General toxicologic pathology: acute, subchronic, and chronic toxicity
- Carcinogenicity
- Irritation pathology (dermal, ocular, vascular)
- Developmental & reproductive pathology
- Genetic toxicology studies
- Ocular pathology
Immunopathology
Tissue Cross Reactivity Assay
- Full tissue bank of non-human primate (NHP) and other species
- Frozen tissues for TCR studies
- Study-specific protocols prepared based on your requirements
- Comprehensive, high-quality audited reports
- Rapid scheduling and reporting
- U.S. FDA & EMEA panel normal human tissue bank (provided by U.S. and European vendors)
Immunohistochemistry
We also provide standardized staining with commercially available antibodies and research antibodies. Here are some examples of our validated Immunohistochemistry (IHC) assays/markers:
- Immune cells (CD3, CD4, CD8, CD19, CD20, CD38, CD138, CD68, CD159a, MPO, MBP)
- Cell proliferation (Ki67)
- Glial cells (Iba-1, GFAP)
- Pancreases (Glucagon, Insulin, Polypeptide, Somatostatin)
- Customized marker development
- Epidermal growth factor receptor (EGFR)
Clinical Pathology
We analyze blood, urine, and other biological fluids to assess organ function, detect biomarkers of toxicity, and monitor the effects of drug treatments. We offer a complete range of clinical pathology services in a variety of animal species:
- Routine and non-routine serum hematology, chemistry, coagulation and urinalysis
- Non-routine cerebrospinal fluid (CSF) chemistry
- Urine microscopic examination
- Urine chemistry evaluation
- Bone marrow smear differentials and M:E ratio
Necropsy & Histology Testing
Our full-service necropsy and histology laboratories are staffed by experienced technologists who provide trimming, embedding, sectioning and special staining to support the evolving needs of our clients’ programs.
Necropsy
We thoroughly examine tissues and organs after death, helping to identify the cause, evaluate drug toxicity, and detect organ-specific adverse effects during preclinical studies.
- Variety of Animal Species
- Tissue Collection and Fixation
- Full Tissue Collection, 10% NBF and Modified Davidson
- Special Collection
- Snap Freezing, Collections for Ribonucleic Acid (RNA), IHC, Electron Microscopy (EM), CSF and Perfusions (whole body/cranial)
Histology
Average baseline slide production is over 80,000+ slides monthly. Special stains include:
- Periodic Acid-Schiff (PAS)
- Cresyl Echt Violet
- Masson’s Trichrome
- Gomori Trichrome
- Mallory Phosphotungstic Acid Haematoxylin (PTAH)
- Prussian Blue
- Von Kossa Calcium
- Alcian Blue-PAS-Hematoxylin
- Periodic Acid-Methenamine Silver
- Alcian Blue
- Van Gieson Picric Acid-Acid Fuchsin
- Sirius Red
- Oil Red O
- Modified Safranin O-fast Green
- Acid-Fast Stain (AFB)
Explore Solutions for Your Program
Explore solutions by development phase, drug modality, therapeutic area, or integrated discovery needs.
You May Also Be Interested In
Get a Quote
Ready to plan your next study? Share your program needs with our team for a tailored estimate.
Frequently Asked Questions
Preclinical pathology testing provides detailed insights into the safety and efficacy of drug candidates. It helps identify potential toxicities, organ-specific effects, and pharmacodynamic responses, enabling drug developers to make informed decisions.
Pathology results guide modifications in dosing, formulations, or compounds, ensuring that only the most promising candidates advance to clinical trials. This reduces risks, accelerates development timelines, and supports regulatory submissions by offering essential data required to demonstrate drug safety and effectiveness.
Preclinical pathology testing provides detailed, audited reports and study-specific protocols, which help clients meet U.S. FDA, EMA, and other regulatory requirements for drug development.
WuXi Biology and Testing provides toxicologic pathology, immunopathology, clinical pathology, necropsy, and histology services, supporting drug discovery and development for various molecule types and therapies.
WuXi AppTec has US and China board-certified anatomic and clinical pathologists (DACVP and DCCVP).
Our pathology team provides the following specialty services: bone, joint, and skeletal muscle pathology, neuropathology (i.e., AAV compound), reproductive pathology, ocular pathology, and carcinogenicity.
We work with a variety of animal species, including non-human primates, rodents, and other common laboratory animals.
Key services include acute, subchronic, and chronic toxicity studies, carcinogenicity, irritation pathology, and developmental & reproductive pathology.
We specialize in tissue cross-reactivity (TCR) studies, IHC assay development, and use a wide range of validated markers to support antibody and nano-antibody research.
WuXi AppTec offers serum hematology, chemistry, urinalysis, CSF chemistry, and specialized bone marrow analyses.
Our necropsy services include comprehensive tissue collection, fixation, and specialized techniques like snap freezing, electron microscopy, and RNA collections.
We provide advanced staining options such as PAS, Masson’s Trichrome, Prussian Blue, and many more to meet specific study needs.
Our histology labs produce over 80,000+ slides monthly, ensuring efficient, high-quality processing with special stains available for diverse research needs.