12
Quality Control
During the course of clinical trials, as well as during scale-up and
mass marketing, it is crucial to maintain uniformity across batches.
Changes to the production process or even the environment the
biologic is produced in can affect the stability and impacts the quality
of different batches. Long-term storage stability can be predicted by
using DLS to perform accelerated stress tests, wherin researchers
extrapolate denaturing conditions for biologics stored in freezers for
long periods of time. By determining the dispersity and aggregation
profile of a biologic prior to scaling up production, researchers can
use the ideal parameters to prevent loss of quality when production
changes are introduced.
From function to formulation to quality and storage, DLS data provides valuable
information for decision-making in biologics discovery and development. Above
we laid out in broad strokes where DLS can be useful, particularly in the field of
biologics research. In the sections that follow, we will zoom in and look at the
scientific theory behind DLS (Section 2), how it is applied to generate useful data
(Section 3), and what the data means for your biologics (Section 4).
