Utility of High Throughput Screening Techniques to Predict Stability of Monoclonal Antibody Formulations During Early Stage Development.

Selecting optimal formulation conditions for monoclonal antibodies for first time in human clinical trials is challenging due to short timelines and reliance on predictive assays to ensure product quality and adequate long-term stability. Accelerated stability studies are considered to be the gold standard for excipient screening, but they are relatively low throughput and time consuming. High throughput screening (HTS) techniques allow for large amounts of data to be collected quickly and easily, and can be used to screen solution conditions for early formulation development. The utility of using accelerated stability compared to HTS techniques (differential scanning light scattering and differential scanning fluorescence) for early formulation screening was evaluated along with the impact of excipients of various types on aggregation of monoclonal antibodies from multiple IgG subtypes. The excipient rank order using quantitative HTS measures was found to correlate with accelerated stability aggregation rate ranking for only 33% (by differential scanning fluorescence) to 42% (by differential scanning light scattering) of the antibodies tested, due to the high intrinsic stability and minimal impact of excipients on aggregation rates and HTS data. Also explored was a case study of employing a platform formulation instead of broader formulation screening for early formulation development.

Psychometric evaluation of the Energy Conservation Strategies Survey.

OBJECTIVE: To examine the internal consistency and test-retest reliability of the Energy Conservation Strategies Survey (ECSS), a tool that was specifically designed to determine if people with multiple sclerosis who attended the six-week energy conservation course actually implemented the strategies taught to them. DESIGN: The instrument ECSS was administered at six weeks and seven weeks post intervention to evaluate the test-retest reliability, while data from six weeks post intervention were utilized to assess the internal consistency of the ECSS. SETTING: Community locations in Illinois and Minnesota, USA. SUBJECTS: Data from 53 participants with multiple sclerosis living in the community were utilized for the psychometric study. MEASURES: Energy Conservation Strategies Survey. RESULTS: The internal consistency of 0.92 reveals that all the items are consistent with each other and measure a single construct. Inferential analyses using intraclass correlation coefficient indicates good test-retest reliability (intraclass correlation coefficient (ICC) = 0.79). CONCLUSION: Findings of the study suggest that the ECSS exhibits high internal consistency and good test-retest reliability. The study implies that the ECSS could be valuable in measuring changes in behaviour over time among people with multiple sclerosis after the completion of the six-week energy conservation course provided by occupational therapists.