Streamlining Analytical Development With LabZient™

Abzena’s LabZient™ analytical platform represents a pioneering approach in the field of analytical development, particularly for complex biologics such as immunoglobulins. This platform utilizes optimized procedures to evaluate critical quality attributes (CQAs) across a wide range of immunoglobulins. LabZient™ incorporates cutting-edge analytical techniques, including Size Exclusion High-Pressure Liquid Chromatography, Capillary Electrophoresis Sodium Dodecyl Sulfate Reduced and Non-Reduced, and Imaged Capillary Isoelectric Focusing. These methods have been validated with certified IgG standards to ensure compliance with quality control standards and expedite the analytical workflow.

The operational activities of the LabZient™ platform involve transferring existing analytical data, drafting an Analytical Target Profile (ATP), conducting in-silico similarity assessments, and customizing methods if necessary. Method performance evaluations are then conducted with test materials and scaled-up materials. The goal is to tailor the analytical methods for the specific molecules being analyzed.

LabZient™ offers a cost-effective and efficient path to clinical trial readiness for complex biologics. It minimizes development time and simplifies qualification and verification processes, setting a new standard in biopharmaceutical analysis.