Preclinical Biologics Development
Core Preclinical Biologics Services
As a laboratory testing partner, our team at WuXi Biology and Testing will customize a preclinical testing program based on your needs to help determine the appropriate studies that will provide meaningful results.
We have experience with many biomolecules, including mAbs, vaccines, peptides, and intact proteins, and can integrate supplemental endpoints, such as safety pharmacology, into general toxicology study designs or as individual projects. Study designs may also be enhanced with pharmacodynamics and immunogenicity analyses, local tolerance evaluation (Draize measurement), and immunomodulating assessment via KLH challenge (TDAR).
Our fully GLP-compliant analytical support includes analytical method development and validation. Plus, with in-house laboratories fully equipped for biologics and biomarker analysis, we can expedite the development of your biosimilar — minimizing the time to clinical trials.
Species Selection and Regulatory Safety Studies
Our in vitro assays and in vivo biology capabilities can help determine the animal species needed for your preclinical studies and, when necessary, human and animal tissue cross-reactivity assays are available. To minimize study lead time and because specialized models are often the most pharmacologically relevant systems for biologic development, we maintain large colonies at our AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care)-accredited sites.
Our toxicology studies and services are compliant with U.S. regulatory agencies, OECD, and NMPA GLP.
Studies
- Pharmacokinetics (PK)
- Dose-ranging or Maximum Tolerated Dose (MTD)
- Single dose (acute toxicity)
- Repeat dose (subacute, subchronic, and chronic)
Immunology Services
- Tissue Cross-Reactivity (TCR)/immunohistochemistry
- Immunochemistry
- Flow cytometry
Other Services
- Analytical chemistry – method development, validation, and sample analysis
- In vitro hemolysis study
Preclinical Immunology Services
To support the development of your therapeutic, our experienced immunology team provides a full range of services, including immunohistochemistry (IHC), immunochemistry, tissue cross-reactivity, and vaccine development.
Immunohistochemistry
Our IHC services include a variety of IHC/IF staining methods to support toxicology and pharmacodynamics studies. To localize the protein of interest, we use your supplied or commercial antibodies on fresh-frozen sections, PFA-fixed frozen sections, and formalin-fixed paraffin-embedded sections.
Our services include:
- Customized assays
- Staining protocol optimization
- Standardized staining with commercially available or research antibodies
- Immunostaining results interpretation
- Comprehensive findings report with microscopic images and morphometry analysis system
Tissue Cross-Reactivity (TCR) Studies
Our comprehensive TCR studies support your research efforts and provide definitive information for regulatory submission.
Our services include:
- Good Laboratory Practice (GLP) compliance to support regulatory submission
- Fresh-frozen tissue panels from three unique donors to meet U.S. regulatory agency, European Medical Agency (EMA), and National Medical Products Administration (NMPA) requirements:
- Normal human
- Non-human primate and rodent
- Other species, customized by interest
- Biosafety Level (BSL) 2 biosafety laboratory certificate
- Rapid scheduling and reporting (14 weeks for entire project)
- Expert team of study directors, pathologists, and technicians
- Experience with a variety of antibodies including monoclonal, bispecific, Antibody Drug Conjugate (ADC), and nano-antibody
Explore Solutions for Your Program
Explore solutions by development phase, drug modality, therapeutic area, or integrated discovery needs.
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