Pre-Clinical & Product Development Assays

Scorpius offers Toxicokinetics (TK) in the form of bioanalytical sampling to examine the systemic exposure, its relationship to dose level, and to characterize the disposition of a target compound during time-course toxicity studies in animals. TK is closely related to pharmacokinetics (PK), defined as the process of drug absorption, distribution, metabolism, and excretion (ADME) in a living organism.

Scorpius can develop highly sensitive methods for quantitation of your target analyte in various biological matrixes using ELISA, Biacore^™, HPLC or Luminex^® technologies.

In all phases of therapeutic product development, potency testing is essential in determining a product’s specific ability to produce a biological response. Cell-based potency assays enable determination of how a particular dose of the product will react in a given biological system. The assays enable monitoring of the biological activity of a product by assuring the identity, purity, strength, and stability of the product through all phases of clinical study.

Using our in-house knowledge and expertise, our team has developed cell-based potency assays for a number of cell therapy products and have qualified them for routine QC product release assays that meet the required regulatory standards.