Capillaire elektroforese

De P/ACE MDQ Plus is een geautomatiseerd, programmeerbaar capillair-elektroforesesysteem dat is ontworpen om complexe monsters snel te scheiden.  Het systeem omvat:

> een modulaire uv/vis-detector met hoge gevoeligheid en selecteerbare golflengte (inclusief filters van 200, 214, 230 en 254 nm om de specificiteit van de te analyseren stof te optimaliseren) met een optische uv-bron, 
> temperatuurgeregelde module voor monsteropslag
> 32 Karat™-software geconfigureerd op een desktopcontroller 
> installatiekwalificatie, operationele kwalificatie 1 (OQ1) en documentatie ter ondersteuning van de softwarevalidatie inbegrepen. 

Zo nodig: 
Applicatieonderssteuning en training beschikbaar. 
Andere detectoren specifiek voor uw toepassing beschikbaar - Optionele DAD en/of LIF

Operationele kwalificatie (OQ3) is NIET beschikbaar voor dit systeem.

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.

A subset of the PA 800 Plus Pharmaceutical Analysis system, the PA 800s Plus provides an automated and quantitative solution for the analysis of protein purity and molecular weight utilizing SDS-gel capillary electrophoresis and IgG Purity and Heterogeneity applications. The innovative system design ensures dependable operation and durability.

The PA 800s system includes:
• High-resolution separation module
• High-sensitivity PDA detection
• Sample storage temperature control
• High-speed system controller with 32 Karat™ Version 10.3 on Win10
• Validated applications for SDS-MW and IgG Purity and Heterogeneity
• Starter kit containing necessary hardware supplies to operate the system is included
• Installation Qualification (IQ) and Operational Qualification (OQ1) of the system are included.

If required:
P/N A81111 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.

For use with the IgG Purity/Heterogeneity and SDS MW Kits.

10 kDa internal standard is used as a mobility marker and all protein mobility is calculated relative to this internal standard.

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 a protein’s isoelectric point (pI). In cIEF, a mixture of sample and ampholyte is introduced into a capillary and subjected to electrophoretic separation. In this process, a pH gradient through which analytes migrate to their respective pI is formed. 

The PA 800 Plus Pharmaceutical Analysis System automates the advanced cIEF technology necessary to successfully achieve high precision and quantitative separations. The use of optimized universal methods and synthetic pI markers attains the highest levels of precision in pI calculation and direct isoform quantitation with on-line UV detection.

This kit provides reagent volumes for analysis of 100 samples and includes: 
• eCap Neutral Capillary, 1 unit 
• cIEF gel 
• cIEF Peptide Marker Kit, 5 vials (pI 4.1, pI 5.5, pI 7.0, pI 9.5, pI 10.0), 240 µL each 
• Sample Loading Solution (SLS), 6 mL 
• CE Grade Water  
 
NOTE: Additional reagents from other vendors are required for this application. Methods and necessary supplies can be referenced in the following AIBs, available for download at www.sciex.com:
• A-11634: Identification of System Parameters Critical for High-Performance cIEF
• A-12015: A Robust cIEF Method: Intermediate Precision for the pH 5-7 Range
• A-12026: High-Resolution cIEF of Therapeutic Monoclonal Antibodies: A Platform Method Covering pH 4-10

Cooling liquid refill for use on temperature controlled instruments, for all Sciex CE systems including the BioPhase, PA 800 Plus, CESI 8000 Plus and P/ACE MDQ instruments (Qty: 1).

Kit Component of P/N 390953 and P/N A10663 (IgG Purity/Heterogeneity Kit.)
For use as an experimental control when separating reduced or non-reduced IgG, with a designated quantity of non-glycosylated heavy chain to test both the resolution and quantitation suitability of the assay prior to running unknowns.

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)

LIF Test Mix, Sodium Fluorescein (20 mL). Test mix for testing the Laser-Induced Fluorescence (LIF) detector and determining the calibration correction factor (CCF) for the system.

Molecular Weight standards (10 to 225 KDa), 16mg/mL (100 µL) for use with the SDS-MW Kit (Part Number 390953) to provide a sizing ladder to reference proteins of interest against.

No more need to mount capillaries. Pre-assembled EZ-CE cartridge (part # A55625) for multiple applications (Purity Analysis, Rapid Charge Variant Analysis, and Fast Glycan Analysis)
> Precision cut tips – ensure uniformity of injection plug from capillary to capillary
> Alignment precision at window – reduces potential failure due to misalignment
> Reduce preparation time for operator – simplifying the process and training requirements