Low Volume, High Throughput Subvisible Aggregate Analysis
Today, formulations development is increasingly important as many drugs are administered subcutaneously at high concentrations (>100 g L-1) and low volumes. At this stage a candidate will be assessed for solubility in various pH- and salt-conditions, excipients, stability in platform formulations under representative stress conditions, such as increased temperature, shaking, and freeze/thaw, as well as compatibility with the primary container. Ideally as much information as possible can be obtained with maximum throughput and minimal material consumption.
The Aura™ and Horizon® system’s 96-well automated format is highly suited to DoE approach to formulations development. Analysis takes about 1 minute per sample, so that several parameters can be tested in a short amount of time with no dilution or sample preparation required. Perform an excipient screen, pH screen, or test buffer conditions in a matter of hours. Since only 5 μL volume is needed per test, analysis does not consume large amounts of material even with replicates.