杂质分析

Sample Preparation

Elemental impurities regulations outline three types of sample preparation:

• Sample dissolution in water
• Dissolution in organic solvent
• Closed vessel digestion (to ensure accurate measurement of volatile Hg)

The JANUS^® G3 BioTX Pro and Pro-Plus workstations automate the tedious and time consuming liquid handling steps of sample preparation. These platforms are consumable-agnostic, meaning they can accommodate multiple modes of purification. The intuitive and flexible WinPREP^® software is easy to use yet capable of running your custom protocols and integrating seamlessly into your existing LIMS. Automate dispensing and fractionation within specific wells with the Plate Shuttle tool to create true, walk-away capabilities which allow you to dedicate your resources to processes that can’t be automated. 

Through our portfolio, we offer solutions for all three. For insoluble samples that require closed-vessel acid digestion, our Titan MPS^™ system is the ideal solution.

Autosampling

For automating the USP <233> process, our NexION^® 350 ICP-MS and Optima^® 8x00 ICP-OES systems can be coupled with the prepFAST intelligent sampling system. When coupled with the prepFAST, our high-performing ICP-MS or ICP-OES systems exceed all USP <233> validation criteria for stability, repeatability, ruggedness, and accuracy.

Measurement

With our industry leading instrumentation, you will be complying with USP and ICH regulations in no time. Our NexION^® 350X ICP-MS is perfectly suited for implementing elemental impurities testing. With easy setup, increased uptime, and superior performance, your lab can comfortably implement and comply with USP <232>/<233> and ICH Q3D.

Where appropriate, ICH and USP allows for the use of ICP-OES technology. The world’s most popular ICP-OES, the Optima^® 8x00 series, delivers breakthrough performance using a series of cutting-edge technologies that enhance plasma stability, simplify method development, and dramatically reduce operating costs.

We also offer alternative atomic spectroscopic techniques, such as flame or graphite atomic absorption. These instruments can be used provided they meet USP and ICH’s stringent requirements for accuracy, specificity, precision, repeatability, and other performance factors detailed in USP and ICH chapters.

Quantitation and Sizing

Resolution matters in manufacturing and QC settings. The Protein Clear^™ assay on the LabChip^® GXII Touch^™ automated capillary electrophoresis platform provides high resolution relative impurity concentrations in minutes. 21 CFR 11 compatible software ensures that digital records and audit trails comply with regulatory requirements.

The Protein Clear assay  is designed for biotherapeutic proteins from 14-250 kD and can detect contamination in non-reduced mAb samples with a limit of detection of 5 ng/µL, or 1% of the main peak. The incorporated IntelliChip^™ assay optimization technology automatically corrects for inter-run chip loading differences, providing the reproducibility and data confidence your QC workflow requires.

The LabChip GXII Touch platform uses microfluidic technology that reduces sample requirements to just 2 µL, and achieves total sample separation  in under 120 seconds, significantly faster than traditional CE methods and SDS-PAGE gels.

Data Analysis

With the new USP/ICH Toolkit, you can rest assured that complying with these limits and procedures will be easier than ever. The Toolkit provides:

• Tools to assist with standard preparation and method development
• Method validation reporting tool
• Standard Operating Procedures (SOP)
• Sample preparation methods
• NexION^® software information

The Toolkit includes a J Value Calculator for accurate calculations of Target Limits (J values) of elemental impurities, making standard preparation and method development easier. It also helps improve efficiencies with the Method Validation Report Tool, which calculates and summarizes method validation data instantly.