A key challenge for companies developing biologics is the control of particles in the final formulation. Managing product contamination from intrinsic and extrinsic particles, and protecting patients from the associated risk, is increasingly important.
When ligand binding is part of the functional activity of a biopharmaceutical, FDA and EMA guidelines require this property be quantified. The Biacore T200 provides real-time and label-free biomolecular interaction analysis and binding assays.
To ensure a long product shelf-life for biopharmaceutical drug products, a stable storage environment is critical. We describe the use of various biophysical techniques as formulation screening tools, to elucidate protein conformation/dynamics.