Scorpius offers a range of services and analytical test methods to support pre-clinical studies for large molecule product development. Our team has a depth of experience and knowledge in bioanalysis including stability, pharmacokinetics (PK), toxicokinetics (TK), immune profiling and cell-based potency assays. We can conduct a wide range of studies within pre-clinical product development and IND-enabling programs.
Bioanalytical Services
Pre-Clinical & Product Development Services
Analytical test methods employed during pre-clinical development should transfer easily to the clinical manufacturing phase. Our scientific staff has the capability and experience to develop and transfer methods efficiently to meet the needs of our clients, and are an integral part of the product development process starting at the earliest stages of pre-clinical evaluation.
Scorpius can evaluate drug candidates for safety and efficacy during animal testing. In-use studies can facilitate the correct dosing of your product and ensure patient safety and product efficacy. By interpreting the results of TK analysis, our experienced team will provide a strategic recommendation for your program. We employ our technology to perform analysis at toxic levels to establish the “no observed adverse effect level” (NOAEL).
PRE-CLINICAL TOXICOKINETIC STUDIES (TK)
Bioanalytical Sampling
Scorpius offers Toxicokinetics (TK) in the form of bioanalytical sampling to examine systemic exposure and its relationship to dose level, as well as 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 matrices using ELISA, Biacore™, HPLC or Luminex® technologies.
Comprehensive Immune Profiling
Flow Cytometry Technology
As a probe into immune system function, Scorpius uses 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. 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 for determining a product’s specific ability to produce a biological response. Cell-based potency assays enable the 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.