Platform Provides Quantitative Determination of Biologic Purity and Heterogeneity

Beckman Coulter, Inc. introduces the PA 800 plus Pharmaceutical Analysis System, a next-generation capillary electrophoresis (CE) platform designed in collaboration with biopharmaceutical development and QC groups.

System advances provide users with a robust and easy-to-use characterization platform that integrates quantitative, qualitative and automated solutions for analysis of protein purity, charge isoform distribution and glycan structure. An emphasis on the portability of assays between laboratories enhances system utility in multi-user/multi-instrument facilities.

“The PA 800 plus automated environment facilitates precise quantitation in SDS-gel analysis, isoelectric focusing and glycan characterization of monoclonal antibodies and other therapeutic proteins,” said Mark Lies, PA 800 plus product manager.

“Capillary electrophoresis is rapidly becoming the gold standard for these applications. This new platform will significantly increase operational efficiency for biotherapeutic characterization in development and QC.”

New PA 800 plus software quickly guides users from set-up through operation in routine applications. Intuitive navigation is achieved through visual cues and insightful help messages. Innovations in system design ensure dependable operation and durability, with minimal maintenance requirements. Modular ultraviolet, photodiode array, and solid-state, laser-induced fluorescence detectors are readily interchanged, allowing a variety of applications to be run on an instrument with a compact footprint.

This system incorporates Beckman Coulter’s new advanced capillary isoelectric focusing (cIEF) technology. Universal methods address gradient stability and protein solubility, and new synthetic pI markers attain the highest levels of precision in pI calculation and isoform quantitation. “The cIEF solution enables biopharmaceutical researchers and technicians to easily implement quantitative isoelectric focusing in a QC environment,” added Dr. Lies.