Since its inception in 2011, ACTIVE BIOMARKERS is supporting multiple biopharmaceutical companies in their preclinical and clinical research programs (Phases I to IV). Operating in BSL2 facilities, and GCLP/ISO 9001:2015 environment, the company currently employs 30 people bringing a wealth of experience in the development, validation, and implementation of bioanalytical methods.
Based on state-of-the-art technologies, encompassing multicolor flow cytometry (Novocyte Quanteon from Agilent), ELISpot (Immunospot from CTL) cellular assay platforms, classical (ELISA), ultrasensitive (SiMoA® from Quanterix), multiplex (Luminex®, SP-X® from Quanterix, MESO QuickPlex SQ 120 from MSD), high-throughput (Ella platform, Gyrolab xPloreTM) and IVD-grade (VIDAS® 3 from bioMérieux) immunoassay platforms, ACTIVE BIOMARKERS provides its partners with multiple fit-for-purpose bioanalytical solutions.
Active Biomarkers services include:
- PK (pharmacokinetics) analyses which aim to measure circulating levels of bioactive therapies
- PD (pharmacodynamics) methods to document their impact on the body
- the quantification of soluble factors/biomarkers
- immunogenicity assessment with the detection and quantification of Anti-Drug Antibodies (ADA)
- phenotypic analyses and functional characterization, in terms of antigen specificity, of immune cell-subsets
This information helps us get a comprehensive knowledge of what the body does to the therapy (PK), and what the therapy does on the body (PD), sheds light on the mechanism of action (MOA) of investigational drugs and their impact on the immune system, and helps identify drug-response biomarkers in terms of efficacy, safety and immunogenicity.
ACTIVE BIOMARKERS is operating in multiple therapeutic areas, particularly in neurodegeneration & neuroinflammation, immune-oncology, inflammatory & autoimmune disorders and infectious diseases. ACTIVE BIOMARKERS is supporting the clinical development of multiple immunotherapeutic products, including preventive and therapeutic vaccines, antibody-based (monoclonal, bispecific antibodies), cell-based (CART cells) and oncolytic virus therapies, but also innovative small molecules.
Furthermore, ACTIVE BIOMARKERS is actively investing in R&D programs to develop, optimize and validate innovative biomarkers / endpoint assays addressing medical needs, based on relevant regulatory guidance.
- Know how in method development and validation
- Large panel of immunoassay and cell-based technological platforms”