PA 800 PLUS PHARMACEUTICAL ANALYSIS SYSTEM PA 800 PLUS PHARMACEUTICAL ANALYSIS SYSTEM Capillary Electrophoresis

Designed for the needs of the biopharmaceutical industry 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. Research Analysts handling therapeutic proteins need: • Automated, qualitative and quantitative analysis • Simplified functionality and maximum operational efficiency • Robust, validated applications that can be transferred globally The PA 800 Plus Pharmaceutical...

Simplified operation 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

High-resolution, quantitative data Quantitative protein purity analysis with SDS-gel capillary electrophoresis IgG Purity and Heterogeneity Assay The PA 800 Plus Pharmaceutical Analysis System automates size separation of proteins and provides high-resolution, quantitative data. The CE SDS-gel application has become the gold standard for protein purity analysis in biopharmaceutical laboratories, replacing manual, low resolution SDS-PAGE. Denatured proteins can be reduced or left intact for separation and subsequent analysis. The PA 800 Plus IgG Purity and Heterogeneity Assay Kit (p/n A10663)...

More information on the SDS-gel application is available in the following application bulletin: “Assay of IgG Purity and Heterogeneity Using High-Resolution Sodium Dodecyl Sulfate Capillary Gel Electrophoresis” (AIB A-1973A). The table below summarizes the results of 18 consecutive SDS-gel analyses of a reduced mouse IgG standard. The relative standard deviation (% RSD) of both the light chain and heavy chain mobility was < 1%, while the quantitative determination of the % light chain (LC), heavy chain (HC) and non-glycosylated heavy chain (NGHC) was also < 1%. Resolution between the NGHC and...

Quantitative protein charge heterogeneity analysis High precision and quantitative separations Accurate determination of a protein’s charge heterogeneity helps establish identity and stability. Capillary Isoelectric Focusing (cIEF) is a powerful technique that allows quantitative analysis of proteins separated by isoelectric point (pI). Capillary Zone Electrophoresis (CZE) provides high speed charge heterogeneity analysis using simple sample preparation. The PA 800 Plus Pharmaceutical Analysis System automates advanced cIEF and CZE technology to achieve high precision and quantitative separations....

Successful transfer and implementation of characterization assays between laboratories is based on a method’s ability to minimize environmental and operator variability. An important indicator of the necessary robustness is intermediate precision. Performing advanced cIEF and CZE on the PA 800 Plus system provides: • Detection of impurities below 0.1% • Repeatability of IgG mobility <1% RSD (1) Salas-Solano O et al. (2011) Intercompany Study to Evaluate the Robustness of Capillary Isoelectric Focusing Technology for the Analysis of Monoclonal Antibodies. Chromatographia. 73:1137-1144 (2) Moritz...

Simplified processing Carbohydrate profiling and analysis for microheterogeneity determination Glycosylation on a protein is an important posttranslational modification that can affect its function, clearance and stability. The PA 800 Plus Pharmaceutical Analysis System simplifies the complex process of profiling carbohydrates associated with glycoproteins. By providing specific and accurate quantitation of glycosylation levels, differences in glycoform quantities and distribution can be determined. Key benefits to carbohydrate profiling using capillary electrophoresis include: • Quantitation...

Oligosaccharide distribution associated with a protein yields a fingerprint that can be used in protein identification. The PA 800 Plus provides easy, quantitative and robust determination of protein microheterogeneity, with a typical analysis time of less The United States Pharmacopeial Convention has included glycan analysis by CE for determination of IgG Microheterogeneity analysis in upcoming Chapter 129 - Analytical Procedures for Recombinant Therapeutic Antibodies, (source: United States Pharmacopeial Covention; www.usp.org) The Carbohydrate Labeling and Analysis Assay is described in more...

Select from below: Detection Mode: Direct Instrument Status and Direct Control Time Remaining: Sample Cover Open 1. Application 2. Samples/Vials 3. Acquisition Output data patti: Print Sequence Report: Pfint Method Report: Summary Kurt Reps rnject Inlet Sample ID Vial Legend W-iZO Wttte £0S& .Wiii* W*U{ *'e:i« Select application Load samples and application reagents The PA 800 Plus software quickly guides users from set-up through routine system operation. Large icons provide intuitive guidance for navigation, while on-screen cues indicate system progress at a glance. Insightful Help menus and...

Video Play List Changing Coolant Tubing Changing Detector Installing Aperture Installing Capillary Installing Cartridge Measuring Capillary Rebuilding Capillary Cartridge Removing Capillary Removing Cartridge Replacing Ejector and Electrode Short Term Capillary Cartridge Storage Trimming Capillary Use the Help and video menu as needed. PA 800 Plus software features include: • Automated sequence table and reagent calculations • Validated applications for SDS-gel, clEF and carbohydrate analysis • Enhanced Help menu and instructional videos • Technical controls enabling regulatory compliance • On-screen...