◆ Clinical Laboratory Testing Services

● Introduction to Lewwin Pharm Laboratory Animal Pathology and Clinical Testing Platform and Team

Laboratory Animal Pathology and Clinical Testing is one of the core disciplines at Lewwin Pharm. The team has extensive expertise in veterinary pathology, with years of deep experience in non-clinical safety pathology evaluation of chemical drugs, traditional Chinese medicine, biologics, cellular and genetic therapies, as well as pathology assessment of animal efficacy models. In pathology research, in addition to experience with common laboratory animals like mice, rats, rabbits, dogs, pigs, and monkeys, the team has accumulated substantial clinical pathology and histopathology data from special animal models, including juvenile animals, severely immunocompromised animals, and transgenic animals. We have established mature pathological evaluation methods for models of ophthalmic diseases, cardiovascular and cerebrovascular diseases, metabolic disorders (diabetes, hyperuricemia, NASH, etc.), localized and systemic infectious diseases, arthritis, primary tumors, and metastases. We have built multiple quantitative and semi-quantitative pathological evaluation systems using routine staining, special staining, and immunohistochemistry. Our professional toxicologic pathology and pharmacodynamic model pathology evaluation systems provide a solid foundation for drug assessment. We are also highly experienced in the pathological evaluation of medical devices, offering pathology assessment services for various types of devices such as implants, tissue ablation devices, and medical adhesives, helping clients successfully obtain clinical trial approvals. Over the years, the team has consistently received satisfactory/excellent certificates in pathology assessments and clinical laboratory proficiency testing organized by authoritative institutions, including the National Institutes for Food and Drug Control, the Toxicologic Pathology Society of the Chinese Pharmaceutical Association, and the China National Accreditation Service for Conformity Assessment (CNAS). The laboratory holds CNAS accreditation. We provide comprehensive, one-stop pathology evaluation services, covering general toxicity, reproductive toxicity, carcinogenicity studies, pharmacology, ocular (including retinal whole mount), respiratory system, nervous system, and various other local/systemic pathology and molecular pathology assessments.

The Lewwin Pharm Pathology Team comprises numerous experienced pathologists and skilled technicians, holding Chinese Certified Veterinary Pathologist (CCVP) qualifications. We collaborate with experts holding American College of Veterinary Pathologists (DACVP) certification to provide peer-review services. The laboratory is equipped with advanced instruments from renowned brands such as Leica and Thermo Fisher and has established a digital pathology diagnostics platform. In recent years, Lewwin Pharm Pathology Team has gained continuous domestic and international recognition, receiving accreditation as a Local Animal Pathology and Medical Laboratory Testing Engineering Technology Research Center. Furthermore, the internationally recognized Good Laboratory Practice (OECD GLP) standards highly endorse the Lewwin Pharm Veterinary Clinical Pathology and Histopathology Research Platform, granting it OECD GLP accreditation in “Veterinary Histopathology and Veterinary Clinical Pathology.”

● Animal Clinical Laboratory Department

The Animal Clinical Laboratory Department is equipped with internationally advanced testing equipment from Hitachi, Sysmex, and others. All analytical instruments and testing methods have undergone systematic and scientific validation, ensuring sample homogeneity and stability, providing a foundation for consistent result evaluation. It enables the detection of all clinically relevant functional indicators in animals.

• Biochemical Testing (over 80 parameters including liver function, kidney function, blood lipids, etc.)

• Electrolyte Testing (Sodium, Potassium, Chloride ions)

• Hematology/Body Fluid Analysis (Complete Blood Count, Five-Part White Blood Cell Differential, Reticulocyte Count, etc.)

• Coagulation Function Testing (TT, PT, APTT, FIB, etc.)

• Coagulation Factor Testing

• Urinalysis (Routine Urinalysis, Urine Sediment, Urine Electrolytes, etc.)

• Bone Marrow Examination (Bone Marrow Cell Morphological Classification)

• Hemorheology and ESR Testing (Blood Viscosity and Erythrocyte Sedimentation Rate)

• Glycated Hemoglobin (HbA1c) Testing

Extensive Background Database for Laboratory Animal Pathology and Clinical Chemistry

• Rats, Mice, Rabbits, Dogs, Monkeys, Pigs

• Juvenile Animals, Severely Immunodeficient Animals

• Model Animals with Solid Tumors and Hematologic Malignancies

Equipped with Advanced Technologies and Automated Instruments

• Hitachi 7180 Fully Automated Biochemistry Analyzer

• Sysmex XN1000 Blood and Body Fluid Analyzer

• Sysmex CS-1300 Coagulation Analyzer

• Fully Automated Erythrocyte Sedimentation Rate Analyzer

• URIT-1500 Fully Automated Urine Analyzer, etc.

●Clinical Laboratory Department Equipment

● Clinical Laboratory Department Qualification Certificates

◆ Pathology Testing Services

● Animal Pathology Department

The Animal Pathology Department is equipped with internationally advanced instruments from Leica, Thermo Fisher, Olympus, and others. All instruments and analytical methods have undergone systematic and scientific validation, ensuring sample homogeneity and stability, which provides a foundation for consistent result evaluation and enables various pathological studies.

• Routine Histopathology Processing (Dehydration, Embedding, Sectioning, H&E Staining)

• Special Staining (PAS, Masson’s Trichrome, Nissl Staining, Oil Red O Staining, etc.)

• Tissue Cross-Reactivity (TCR) Studies

• Pathological Diagnosis and Analysis

• Immunohistochemistry (IHC)

• Immunofluorescence (IF)

• Frozen Sectioning

Equipped with a Range of Internationally Advanced Pathology Equipment from Leica, Thermo Fisher, Olympus, etc.

• Fully Automated Tissue Processor (Dehydrator)

• Paraffin Embedding Station

• Semi-automated Rotary Microtome

• Frozen Section Microtome (Frozen Section Microtome)

• Fully Automated Slide Stainer and Coverslipper

• Immunohistochemistry (IHC) Stainer

• Whole Slide Scanner (Digital Pathology Scanner)

• Biological Microscopes, Image Analysis Systems, and other advanced instruments

 ● Pathology Research Department Equipment

● Routine Histopathological Tissue Sections from Laboratory Animals

● Special Histopathological Tissue Sections from Laboratory Animals

● Histopathological Tissue Sections from Common Disease Models in Laboratory Animals

● Digital Pathological Analysis of Drug Pharmacodynamics Evaluation (IHC and HE Staining)

● Pathology Department Qualification Certificate

National Institutes for Food and Drug Control and National Recognized Proficiency Testing Certificate for Clinical Laboratory and Pathology