SCIEX

IgG Purity/Heterogeniety Assay Kit

Reference: ABS-A10663

Includes IgG Control Standard 1-pack and all chemistries.
The IgG Purity/Heterogeneity Assay has been developed for researchers employed in industrial biotechnology who are developing and manufacturing IgG reagents for research, diagnostic and therapeutic use.

This assay has been specified for use on the PA 800 Plus to assess the purity and heterogeneity of IgG reagents in both a reduced and non-reduced state. The methodology involves heat-denaturing a specified concentration of IgG (both reduced and non-reduced) in the presence of SDS, and separating these proteins by size using high-resolution capillary gel electrophoresis technology. This assay will detect impurities as low as 0.1% and includes an IgG control with a designated quantity of non-glycosylated heavy chain to test both the resolution and quantitation suitability of the assay prior to running unknowns

Assay chemistry includes:
• Separation Capillary, 57 cm x 50 µm ID bare fused-silica, (2)
• SDS Gel Separation Buffer (proprietary formulation), 140 mL
• SDS Sample Buffer, 100 mM Tris-HCl, pH 9.0/1% SDS, 50 mL
• IgG Control Standard, 1 mg/mL in SDS sample buffer , 1 mL
• Internal Standard, 10 kDa protein, 5 mg/mL, 0.4 mL
• Acidic Wash Solution, 0.1 N HCl, 100 mL
• Basic Wash Solution, 0.1 N NaOH, 100 mL
• IgG Purity and Heterogeneity Analysis Guide, (1)

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SCIEX

PA800 Plus Pharmaceutical Analysis CE System

Reference : ABS-A66528

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, IgG Purity and Heterogeneity analysis, charge heterogeneity analysis utilizing advanced capillary isoelectric focusing, and carbohydrate profiling for the assessment of glycoprotein microheterogeneity.
Modular detector 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 10.3 on Win10
• Validated applications for SDS-MW, IgG Purity and Heterogeneity, cIEF, and glycan analysis
• Starter kit containing necessary hardware supplies to operate the system
• Installation Qualification (IQ) and Operational Qualification (OQ1) of the system are included.

If required
P/N A81010 must be added to the order for system start-up and installation.
System application installation and training must be added when desired.
Operational Qualification (OQ3) must be added for complete system validation.