Preclinical tests assess the toxicity of a drug and examine its potential effects on the human body. These tests are conducted and in-vivo (within the living - animal testing) and in-vitro (within the glass- test tubes, etc) and are required by pharmaceutical regulators to ensure that a drug is safe for human use and shows efficacy prior to beginning human clinical trials. In-vitro testing includes e.g. analysis of receptor binding, investigations regarding the mechanism of action and the chemical structure, confirmation of the physical and chemical properties.

Also, therapeutic proteins are frequently immunogenic in animals. Immunogenicity in animal models is not predictive of immunogenicity in humans. However, assessment of immunogenicity in animals may be useful to interpret nonclinical toxicology and pharmacology data. In addition, immunogenicity in animal models may reveal potential antibody related toxicities that could be monitored in clinical trials.

Vela offers the complete analytical portfolio ranging from ELISA (PK) and LUMINEX (cytokine pattern analysis) technologies to SPR (Immunogenicity) methodology to support preclinical testing.