MilliporeSigma has launched its BioReliance Product Characterization Portfolio of tests for quality assessment of biologics. This new suite of tests provides critical information biologic manufacturers need to design production processes. The purity, safety and efficacy of a drug must be identified and continuously monitored in order to support development and meet regulatory requirements necessary for commercialization. Manufacturers can better understand their molecule’s function through comparison of structure and activity. 
 
This portfolio of assays enables the characterization of mAbs, including physicochemical and immunochemical properties, biological activity, stability and purity as outlined in the ICH Q6B guidelines, as well as EMEA and FDA regulatory requirements. Also, capabilities, such as hydrogen-deuterium exchange technology and highly sensitive surface plasmon resonance instrumentation, are available.
 
BioReliance services offer risk-mitigating approaches, critical testing services and customized solutions.