View our comprehensive portfolio of products for drug development and patient diagnosis and monitoring
Our products are trusted worldwide in research, clinical, and commercial laboratory settings.
Functional and biomarker assays for the exploration of every angle of the complement system
Our cell-based bioassays are based on iLite® technology – a cleverly designed cell-based assay system with reporter gene readouts
AAV Neutralizing Antibody (NAb), Total Antibody (TAb), and Complement Activation assays designed to provide a comprehensive view of vector immunogenicity
Solutions for detecting and semi-quantitating IgG antibodies against CCP
Our extensive CRO Services offer bioanalysis, biomarker discovery, and GMP QC testing.
With over 30 years of experience in autoimmune diagnostics, our ISO15189-certified specialist laboratory can help you reach the correct diagnosis. We also provide testing services and support for therapeutic drug monitoring.
Let us develop a custom iLite® cell line tailored to your needs.
Our cell services are highly reliable and innovative, tailored to your manufacturing needs
We deliver robust characterization solutions for biosimilars and biobetters with our side-by-side assay panels, Fc-effector function testing, and iLite® bioassays.
Biosimilar and Biobetter Characterization
Characterization is critical for proving that a biosimilar matches its reference product or that a biobetter offers improved functionality. Functional assays and regulatory-compliant formats provide the evidence needed for approval and market success.
We provide specialized characterization solutions for biosimilars and biobetters that help meet regulatory expectations with confidence. Our Our iLite® cell-based bioassays, Fc-effector function panels, and customized services help demonstrate similarity, assess potency, and support optimization of product performance throughout development.
Our biomarker profiling solutions support you with:
Regulatory Compliance: Generate evidence that supports EMA and FDA requirements for biosimilar comparability.
Functional Insight: Confirm mechanism of action and Fc-effector function.
Custom Solutions: We develop tailored panels for your drug’s unique attributes.
Reporter gene assays quantify pathway activation linked to therapeutic mechanism of action (MoA) across many targets. Ready‑to‑use cells and standardized protocols enable rapid method transfer and reproducible results.
ADCC, ADCP, and CDC assays measure effector mechanisms that drive clinical performance of antibodies. Assays are optimized for sensitivity and can be qualified for comparability, stability, and lot release programs.
We tailor assay selection, design, and analysis plans to the attributes of your molecule and target product profile. Deliverables include study plans, data packages, and tech transfer for internal or external QC labs.
Write us a message and a product specialist will get in touch
