Guide to Making Useful Measurements of Monoclonal Antibodies (mAbs) with Dynamic Light Scattering
Dynamic light scattering (DLS) is a powerful technique that is amenable to measurement of biological samples, particularly proteins and biopolymers. One of the fastest growing classes of pharmaceutically active biologics are antibodies. These highly versatile proteins are used as the major functional element in immunoassays and other rapid diagnostics, in vaccine production, and as the primary component of a wide array of injectable protein drugs. In all these applications it is essential that antibodies remain intact, and monomeric. Failing to adhere to these strict and exacting standards compromises the processability, activity, and shelf stability of antibody-based products. When DLS is used to its full potential, aggregation of proteins can be detected and the size of monomeric protein can be determined to a very high degree of certainty. In order to demonstrate this principle, we compare aggregation studies conducted on pharmaceutical-grade monoclonal antibody (mAb), with results obtained for a common protein, serum albumin (BSA).