Safety Assessment
Ensure therapeutic safety with our immunogenicity assays, hemocompatibility panels, and complement pathway testing designed to meet global regulatory standards.
Safety Assessment
Safety Assessment
Safety assessment is a cornerstone of drug development. It evaluates how a therapeutic interacts with the immune system and blood components, helping predict adverse reactions and guide formulation strategies.
How we can help
We provide comprehensive solutions for immunogenicity and hemocompatibility testing to ensure your therapeutic’s safety profile is well understood. From anti-drug antibody (ADA), neutralizing antibody (NAb), and total antibody (TAb) assays to complement pathway analysis, we deliver comprehensive bioanalytical solutions that ensure regulatory compliance and patient safety.
Choose from our validated ADA, NAb, and TAb assays, WIESLAB® complement panels, or leverage our CRO services for customized, GMP-compliant testing.
Our safety solutions can help in:
- Risk Mitigation: Detects immune responses such as ADA or complement activation that could compromise efficacy or cause harm.
- Regulatory Approval: Provides critical data for agencies like FDA and EMA to demonstrate product safety.
- Clinical Success: Ensures patient safety and supports informed dosing decisions.
Our Safety Assessment Solutions
-
COMPLEMENT ASSAYSOur hemocompatibility panels evaluate complement activation, coagulation, platelet function, and hemolysis to profile interactions between your product and blood components. The panels reveal inflammatory risk and guide formulation and dosing strategies. Supplied as standardized test packages or tailored to your modality, they are ideal for medical devices, biologics, and gene therapy materials in safety assessment programs.
-
COMPLEMENT ASSAYS
WIESLAB® complement assays provide pathway‑specific readouts for classical, alternative, and lectin activation. The kits generate reproducible, quantitative results that map complement involvement in adverse reactions. In convenient ELISA formats, they streamline hemocompatibility studies, lot release checks, and investigational troubleshooting without complex workflows.
-
CRO SERVICES
Our CRO team develops, qualifies, and executes ADA and NAb assays aligned with regulatory expectations. You receive high‑quality data, risk assessments, and reports ready for regulatory review. Offered under GMP or non‑GMP conditions, these services support screening, clinical timepoints, stability, and post‑marketing surveillance.
-
CELL-BASED BIOASSAYS
Our iLite reporter gene assays offer sensitive, MoA‑reflective readouts for immune activation and pathway signaling. Available as ready‑to‑use kits or customized cell lines, they reduce variability and accelerate assay setup for screening, stability, and lot release.
-
CELL-BASED BIOASSAYS
We create bespoke cell‑based systems that reflect your product’s mechanism of action, from effector function to complement‑mediated outcomes. Assays are delivered qualified or validated for intended use and are suitable for comparability, potency, and safety studies.
-
GENE THERAPY ASSAYS
For AAV therapies, we provide platforms for neutralizing and total antibody detection alongside complement activation analysis to mitigate infusion related risks. Assays are standardized for cross study comparability and are suited to candidate screening, patient eligibility checks, and clinical monitoring.
-
WIESLAB DIAGNOSTIC SERVICES
Wieslab Diagnostic Services offers therapeutic drug monitoring for a wide range of biopharmaceuticals. We measure drug concentrations and anti-drug antibodies (ADA) from patient serum.
Contact our team of experts
Write us a message and a product specialist will get in touch
