TS_AES - Comprehensive and Critical Support for CMC Strategy and CIEF Method Lifecycle - Presentation Sponsored by Advanced Electrophoresis Solutions Ltd.

Advanced Electrophoresis Solutions Ltd (AES) is a total solution provider in iCIEF and related cutting-edge technologies. AES has been collaborating with leading biopharmaceutical companies answering their diversely urgent needs. AES stays with customers to give supports for their CMC strategy and entire method development cycle.

AES provides critical reagents including high-performance carrier ampholytes for mAb, ADC, bispecific, and fusion protein with a good lot to lot consistency, which saves millions of dollars for our customers for essential QA/QC of commercial products and facilitates file applications to regulatory agencies. AES also offers a critical reagent service to customize reagent/consumables based on customers’ criteria.

AES’ patented capillary diameter transformation technique (CDTT) allows achieving high resolution and highly efficient iCIEF fractionation. CEInfinite automated preparative system solves a bottleneck existing in the application of iCIEF in the biopharma industry. The obtained fractions by preparative iCIEF can be used for downstream analysis such as native protein characterization, reaction study, and peptide mapping. This multifunctional platform can be robust for iCIEF-MS online coupling to perform rapid characterization and charge isomer identification. The high resolving power of iCIEF combined with routine analytical methods becomes a powerful tool for new therapeutic protein discovery, formulation studies, and stability study, etc.

AES’ CEInfinite analytical iCIEF system is utilized for the direct transfer of any existing iCIEF platform methods across product development and QC. Equivalent or better applications performance can be achieved compared to the existing iCIEF instruments. CEInfinite is 21 CFR Part 11 compliant, it is ready to be established as a routine method for protein characterization and purity determination from formulation to manufacturing QC.