Bioanalytical Services

Clinical Trials Services

Scorpius provides comprehensive analytical testing support for all phases of human clinical trials. Our experienced team has an excellent track record in providing rapid and high-quality clinical bioanalytical services, supplying critical data for inclusion in regulatory filings.

Our analytical test methods developed during pre-clinical product evaluation transition easily to clinical-phase testing. In many cases, our scientific staff have been an integral part of our client’s development program from the earliest stages of pre-clinical work, ensuring a comprehensive understanding of our client’s needs.

We offer a wide range of analytical techniques for testing of clinical samples, enabling effective analysis of drug products, metabolites, and pharmacodynamic biomarkers from complex biological matrices. Our offerings include whole blood and PBMC processing and fractionation, PK and PD analysis, immunogenicity testing and functional immune profiling.

Automated Whole Blood Fractionation

Data Integrity

Consistent sample processing is critical for biomarker-driven assays, as the results can be sensitive to pre-analytical variables. Scorpius safeguards the integrity of biomarker assay data through the use of an automated system that enables fast and gentle isolation of any cell subset from whole blood. The autoMACS® Pro Separator provides a robust, standardized whole blood and PBMC processing fractionation.

Sample Processing Capabilities:

PBMC (peripheral blood mononuclear cell) isolations, cryopreservation, characterization and same- or next-day processing
Blood fractionation for isolation of serum, plasma and multiple cell types
Quantity, quality and purity assessment of cell subsets
Custom processing studies
Standardized SOPs for laboratory services that can be customized on demand

Scorpius' autoMACS^® Pro Separator

The autoMACS® Pro Separator enables fast and gentle isolation of virtually any cell type, ideal for downstream applications like flow cytometry.

Our Technologies

Clinical PK / Bioavailability Studies

Studies for Determining Drug Exposure

Pharmacokinetic (PK) studies provide the basis for determining drug exposures in the body over time. PK parameters are used in the evaluation of the drug’s absorption, distribution, metabolism and excretion (ADME) processes. Scorpius develops and validates bioanalytical methods in human biological matrices to provide pharmacokinetic data during clinical trials.

Bioanalytical Methods

Our highly experienced team of scientists can develop robust bioanalytical methods and calculate PK parameters by non-compartmental analysis (NCA) to support PK studies for the analysis of drugs and metabolites in biological fluids. We have implemented validated software for NCA, enabling the generation of formal reports satisfying regulatory agency requirements.

PKPD Analysis

Relationship of Exposure and Efficacy

Pharmacokinetics (PK) describes the fate of a therapeutic in the living organism, while pharmacodynamics (PD) studies the relationship between drug concentration at the site of action and the observed pharmacological response. PKPD analysis assesses the relationship between the drugs’ in vivo exposure and efficacy. Scorpius can provide interpretation of PKPD data for all phases of clinical study using our in-house validated software, WinNonlin®.

Compartmental & non-compartmental analysis using WinNonlin® software:

Bioavailability/Bioequivalence
PKPD analysis
Statistical analysis (SAS^®)
Prediction of human PK via allometric scaling and in vitro scale-up

Immunogenicity Testing

Measuring Adverse Immune Responses

Immunogenicity testing measures any adverse immune response generated by a biologic, such as reduced efficacy or autoimmune, allergic and anaphylactic reactions in the body. Scorpius scientists offer deep expertise in anti-drug antibody (ADA) assays (screening, confirmation and titration).

ADA Assays to Measure Immunogenic Responses

We develop ADA assays to reliably measure and validate immunogenic responses in a variety of biological matrices for your regulatory filing. We offer Biacore^™ and ELISA-based immunogenicity assay development and validation to quantitate the unique ADA effects of antibodies, recombinant proteins, peptides, etc.

Scorpius has extensive experience designing, validating and optimizing immunogenicity assays according to regulatory guidelines.

We use FDA-recommended multi-step approaches to measure ADA response to your drug candidate:

Screening
Confirmation
Titer Determination

All confirmed ADA-positive samples are then tested for neutralizing antibodies using Neutralizing Antibody (NAb) assays.

Flow Cytometry-Based Assays

High-Throughput Quantitative Analysis

Immunotherapeutic product development requires high throughput and robust quantitative analysis of the immune system in the tumor microenvironment, peripheral blood and other host tissues. To meet this need, Scorpius BioManufacturing offers state-of-the-art analytical flow cytometry.

Highly Multiplexed Immunophenotyping for Monitoring Human Immune Biomarkers

Scorpius has developed a standard set of surface marker panels to use surface and intracellular marker combinations for immunophenotyping and can custom-design panels as needed.

Intracellular Cytokine Staining

A short-term consequence of immune cell activation is the production of cytokines by responsive cells. The frequency of responsive cells and the types of cytokines they produce can be useful biomarkers for monitoring immune responses to vaccines or specific antigens, or to monitor immune function as related to disease progression.

MHC-Peptide Tetramer Assays for Visualizing and Quantifying Antigen-Specific T Cells

Samples like PBMCs or whole blood can be mixed with MHC-peptide tetramers for analysis via flow cytometry to detect, quantify and sort CD4+ or CD8+ T cells that are specific for peptide antigens of interest. The flow cytometric signal can also be used to determine the existence and the strength of some cell-mediated immune response to the certain pathogen from which the antigen peptide is derived.

Tetramers Providing a Wider Base of HLA Molecules

Scorpius offers tetramers that will provide a wider base of HLA molecules and enable them to be combined more effectively with functional assays.

The use of combinatorial approaches, both for production of tetramers and for flow cytometric analysis, will provide in-depth characterization, breadth and functional data.

Functional Immune Profiling

Understanding Immune Changes

Scorpius offers a comprehensive approach for analyzing human immune function. The application of immunoprofiling, in the context of clinical studies, allows investigators to understand immune changes that might happen in healthy individuals, those that occur with environmental exposure and the connection between the human immune system and disease.

Methodologies to Comprehensively Monitor and Understand Immune Response:

Conventional & Spectral Flow Cytometry

Isoplexis Technology

Luminex^® Multiplex Assay

ELISpot^® and FluoroSpot Technology