Light Scattering as a Sensitive Tool for Rapid Pre-Formulation and Formulation of Proteins

Purpose: Developing a rapid screening tool for the selection of various excipients in pre-formulation of proteins /peptides is highly desirable to save time and precious API. Current widely used methods in the field are time consuming and formulations must be kept on accelerated stability conditions in order to select a lead candidate. Right angle light scattering (RALS) measures aggregation of formulations in a shorter time and the data correlates to the molecule stability. Methods: Three different antibodies, one 60 kDa protein, and one 3kDa peptide molecule were formulated and the data on right angle light scattering results measured by measuring excitation and 320 nm and emission at 320 nm were compared with conventional screening tool. Results: The data indicated that the RALS provide comparable results during pre-formulation and formulation that involves screening for ions, pH, and stabilizers in much shorter time without time spends in performing accelerated stability in most cases. RALS data correlates with the Z average size of dynamic light scattering data. Conclusion: This technique helps in selecting the suitable formulation in most native condition, as no sample processing is required. This technique is fast and gives very reliable and comparable data to other analytical techniques to develop formulation of protein, and peptides