Preclinical Development of Biologics
Our scientific team is highly experienced in assisting our sponsors with program requirements and study design based on the product’s mechanism of action, and incorporating aspects such as the biologics clinical dosing route and regimen.
WuXi AppTec has extensive experience in non-human primate PK studies as well as general toxicity studies lasting up to 9 months including intravenous infusion in rodents and non-rodents. We have experience with many biomolecules including mAbs, vaccines, peptides and intact proteins. Supplemental studies such as safety pharmacology can be included in 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 immunogenic or immunotoxic.
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 biosimiliars 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. Usually the non-human primate will be the most pharmacologically relevant species for biologics development so we maintain large colonies of cynomolgus monkeys at only AAALAC accredited supplier in China to minimize the study lead-in time.
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.
FDA, OECD, NMPA GLP-compliance across a range of studies:
- PK studies
- Dose-ranging or 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
- Safety pharmacology–CNS, respiratory and cardiovascular (hERG)
- Flow cytometry