Category: Automation and High-Throughput Technologies
A novel, user-friendly, and automated platform for the preparation of biopharmaceutical products for analysis via capillary gel electrophoresis (CGE) was developed. CGE currently stands as a gold standard for quantitative fragment and purity analysis of protein biopharmaceuticals. However, current manual sample preparation methods for CGE are laborious and time-consuming, requiring around 2 hours of hands-on time prior to analysis. Further, these methods require molecule-specific reagents for sample preparation, adding to the complexity and tedium of manual batch analysis of multiple products. The newly developed automated platform leverages the capabilities of an automated liquid handling platform to prepare up to 32 samples from multiple products and conditions in under one hour. The method automatically aliquots sample material from standard sample tubes, dynamically normalizes concentrations, and prepares samples for analysis by selectively adding corresponding buffers based on the respective product's specific requirements. An intuitive graphical user interface (GUI) was developed to guide the user in system setup, as well as to provide an interface for the import of a LIMS query to load information needed for analysis. The results have demonstrated that the automated process is robust and comparable to the standard, hands-on sample preparation. Ultimately, the process serves as a step towards an end-to-end solution for integrated analysis of critical quality attributes within a high-throughput process development environment.
Rod Brian Jimenez– Associate Scientist I, Medimmune Inc., Gaithersburg, MD