Therapeutic proteins make up a rapidly growing segment of global pharmaceutical production. These complex molecules require accurate characterization of product purity, heterogeneity and identity. This includes data regarding their stability, shelf life and related manufacturing processes.

Automated and Quantitative Analysis of Biologics

The PA 800 plus Pharmaceutical Analysis System* was designed in collaboration with biopharmaceutical development and QC groups. This platform provides analysts with robust and easy-to-use characterization, integrating quantitative, qualitative and automated solutions for protein purity, charge isoform distribution and glycan analysis. During the design of the PA 800 plus, Beckman Coulter emphasized assay portability, enhancing the overall system utility in multi-user, multi-instrument facilities.

Automated applications provide reproducible and quantitative results:

• High resolution SDS-gel separation for protein purity determination
• Automated, Quantitative IgG Purity Analysis
• Advanced capillary Isoelectric Focusing (cIEF) for charge heterogeneity analysis
• Carbohydrate profiling for assessment of glycoprotein microheterogeneity

Simplified operations and a robust platform enhance operational efficiency:

• Specialized software quickly guides routine users from set-up through results
• Innovations in system design ensure dependable operation and durability, with minimal maintenance
• Modular UV, photodiode array and laser-induced fluorescence detectors can be easily interchanged
 
The PA 800 plus Pharmaceutical Analysis System provides a comprehensive, automated, and quantitative solution for the characterization and analysis of proteins. Innovative system design ensures dependable operation and durability. The PA 800 plus application menu includes SDS-gel molecular weight analysis, charge heterogeneity analysis utilizing advanced capillary isoelectric focusing technology, and carbohydrate profiling for the assessment of glycoprotein microheterogeneity. Modular design provides for the simple interchange of detectors.

The PA 800 plus System includes:

• High-resolution Separation Module
• High-sensitivity UV, PDA, and Solid-state Laser-induced Fluorescence Detection
• Sample Storage Temperature Control
• High-speed System Controller with 32 Karat™ Version 9.0 and PA 800 plus software
• Validated Applications for SDS-MW, IgG, cIEF, and Glycan Analysis
• Starter Kit Containing Necessary Hardware Supplies to Operate the System
• Installation Qualification and Operation Qualification of the System
• System Application Installation and Training