Pre-Clinical & Product Development Support

Pre-Clinical & Product Development Assays

Pre-clinical Toxicokinetic Studies (TK)

Bioanalytical Sampling

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.

Technology-Based Assays Offered by Scorpius:

Comprehensive Immune Profiling

Flow Cytometry Technology

Scorpius provides state-of-the-art flow cytometry technology to determine cell phenotype and examine signaling pathways and functional responses to therapeutics at the single cell level as a probe into immune system function. Custom panel design and ex vivo methodologies provide analysis of a wide range of immune subsets to complement the evaluation of in vivo therapeutic effects. Scorpius offers functional assays including apoptosis, tetramer analysis, cytokine expression, and Treg cell suppression.

Cell-Based Potency Assays

Determining Biological Response

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.