Preclinical Development of Biologics
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Preclinical studies for biologics are customized to your product and designed to generate meaningful results through the performance of a thorough scientific and regulatory-compliant program.
Our scientific team is highly experienced in assisting you with program requirements, study design based on your product’s mechanism of action and incorporating aspects such as the biologic’s clinical dosing route and regimen.
WuXi AppTec provides extensive experience in preclinical assessment of your biologics and can help you determine the appropriate studies and species to assure scientific relevance. We have experience with many biomolecules including mAbs, vaccines, peptides and intact proteins. Supplemental endpoints such as safety pharmacology can be integrated into general toxicology study designs or as individual projects depending on the nature of the test article. We also provide fully GLP-compliant analytical support including analytical method development and validation as well as an assessment of the test article’s potential immunogenicity or immunotoxicity.
Study designs may typically be enhanced with pharmacodynamic and immunogenicity analyses, local tolerance evaluation (Draize measurement) and immunomodulating assessment via KLH challenge (TDAR). WuXi AppTec’s laboratories are equipped for in-house analyses of biologics and biomarkers and our robust study designs enable us to expedite the development of your biosimilar minimizing the time to clinical trials.
Species Selection for Preclinical Studies
WuXi AppTec’s capabilities for in vitro assays and in vivo biology can help determine the relevant animal species for preclinical studies. In addition, tissue cross-reactivity assays with both human and animal tissues are available where needed to provide further guidance. The non-human primate (NHP) may be the most pharmacologically relevant species for biologic development so we maintain large colonies of cynomolgus NHPs at only AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) accredited sites in China to minimize the study lead-in time. The unique challenges encountered in some complex therapeutic approaches (such as human- or disease-specific cell and tissue activity) can be discussed and alternative approaches may be used on a case by case basis. We work with you as a team to develop the best studies answering the critical safety assessment questions.
Our preclinical studies for biologics are customized for each product and designed to generate meaningful results through the performance of a thorough scientific and regulatory compliant program.
U.S. FDA, OECD, NMPA GLP Compliance Across a Range of Studies:
- PK studies
- Dose-ranging or Maximum Tolerated Dose (MTD) studies
- Single dose (acute toxicity) studies
- Repeat dose (subacute, subchronic and chronic) studies
- Other services available:
- Analytical chemistry–method development, validation and sample analysis
- In vitro hemolysis study
- Tissue Cross-reactivity (TCR)/immunohistochemistry
- Flow cytometry