Preclinical Development of Biologics

Preclinical Studies

As your partner, our team of experts will customize a preclinical testing program based on your unique needs to help determine the appropriate studies needed to 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

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 Non-human Primate (NHPs) are often the most pharmacologically relevant species for biologic development, we maintain large colonies of cynomolgus NHPs at our AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care)-accredited sites in China.

U.S. FDA-, OECD- and NMPA GLP-Compliant Toxicology Studies and Services

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