Assay development and validation

Method development & validation

Analytical methods require development, validation, and controls. Assays and measurement systems must be viewed as a process. This measurement process is made up of methods, software, reagents, analysts, sample preparation, environmental conditions, and instrumentation/equipment. At ABL, stringent quality risk management techniques are used to identify factors that may influence precision, accuracy, linearity, signal to noise, limits of detection and quantification, or any other assay attributes to achieve optimal assay results. We can develop or transfer a method, optimize and qualify customized assays in multiple application fields: biomarker detection and quantification, immunophenotyping, anti-drug antibody detection, pharmacokinetic studies…

Our assay qualification methods are conducted following applicable FDA, EMA and ICH guidelines on validation of bioanalytical methods


Production of microparticle-based reagents

Leveraging our long-time know-how in coupling biomolecules onto several kinds of beads (magnetic, latex, or fluorescent), we produce, for multiple clients, lots of bead-based reagents for microagglutination, antigenicity or serology assays.

Microparticles can be coated either with your specific biologics or reagents from commercial suppliers. ABL can for example develop suitable reagents for Luminex or Simoa™ (Quanterix).

We are notably the provider of the world largest supplier of Spherotest microparticle-based kits. These assay kits measure the specific concentration of antibodies by an easy and rapid microagglutination technique.

Want to learn more on our assay development capabilities?

Contact us