New antibody standard could aid biopharma development

The National Institute of Standards & Technology has a repository of approximately 1,200 reference materials that scientists can purchase to calibrate their instruments and establish quality-control protocols. The newest reference material, a monoclonal antibody, may be the agency’s most extensively characterized yet. The Y-shaped protein, which NIST released in late July, has undergone a battery of tests to comprehensively assess its composition, purity, and long-term stability. The reference material—dubbed NIST RM 8671—will give biopharmaceutical companies, technology developers, and regulators a common substance for comparing the performance of existing analytical technologies and for testing new ones. The extensive characterization is the outcome of more than three years of collaboration between NIST and the biopharmaceutical industry, says John Schiel, the NIST chemist who led the effort. The reference material, which costs $858 for 800 μL of a 10 mg/mL solution, is made of an immunoglobulin G antibody donated by MedImmune. Richard Rogers, a scientist at Just Biotherapeutics, is leading a consortium that hopes to replace many of the quality-control assays that biopharma companies usually perform when releasing protein-based products with a so-called multi-attribute method based on mass spectrometry. He plans to use the NIST standard to evaluate the method.