Increasing complexity of modern biotherapeutic characterization, monitoring, and quality control assays require even more demanding analytical techniques to accurately define and assess critical quality control attributes (CQAs) related to product safety, stability, and efficacy.
The ACQUITY UPLC H-Class PLUS Bio System provides the same high resolution, high sensitivity separations you have come to expect from UPLC Technology, with the flexibility and ruggedness to run all the chromatographic modes you require – ion exchange (IEX), size exclusion (SEC), hydrophilic interaction (HILIC), or reversed-phase – all on the same system.
The complete flow path is engineered with iron-free, bio inert materials, helping your lab extend the lifetime of your instrument and maintain optimal bioseparations performance.
Auto•Blend Plus Technology
The bioQuaternary Solvent Manager (bioQSM) automatically blends mobile phase combinations and gradients on demand, enabling you to obtain the optimum retention and selectivity requirements for your analysis. Designed with bio-inert materials, the bioQSM accommodates the aqueous, high ionic strength mobile phases and organic solvents used in biopharmaceutical applications.
Auto•Blend Plus Technology automatically blends your mobile phase to a specified pH and ionic strength or organic modifier percentage, for an infinite set of analytical conditions. By blending on-line to the desired pH and ionic strength conditions, you can significantly reduce the number of buffers you need to prepare for method development and for routine use.
Size exclusion chromatography
The ACQUITY UPLC H-Class PLUS Bio System is uniquely designed for size-exclusion chromatography (SEC) and the characterization of proteins and their aggregates.
The ACQUITY UPLC H-Class PLUS Bio, enabled by Auto•Blend Plus Technology, enables automatic calculations and proportioning of buffer stocks, based on pH or ionic strength, making any possible buffer combination available - maximizing productivity by eliminating the labor intensive step of manually mixing buffers.
In addition, Waters ACQUITY UPLC BEH200, 1.7-µm SEC column chemistry utilizes the first commercial sub-2-µm particle giving biopharmaceutical laboratories the ability to separate and quantify monoclonal antibodies (mAb) and their aggregates in less than four minutes, faster than with conventional liquid chromatography, and still meet FDA requirements. Monitor mAb aggregation at speeds up to 10 times faster at comparable or better resolution than before, allowing you to overcome separation challenges and develop novel biotherapeutics in less time and at lower costs.
Ion exchange chromatography
For the analysis of biomolecules including monoclonal antibodies, recombinant proteins, DNA/RNA, and vaccine components, the ACQUITY UPLC H-Class PLUS Bio System and Protein-Pak Hi Res, Ion-Exchange (IEX) columns give biopharmaceutical manufacturers the ability to reproducibly characterize various charge states of intact biomolecules - with greater resolution and speed. This improved monitoring capability helps manufacturers ensure high product quality and efficacy.
Waters IEX columns were developed to assist in the UPLC characterization of recombinant proteins and monoclonal antibodies found in many of today's biopharmaceutical therapeutics. These non-porous, high-ligand density particles overcome the effects of protein diffusion on peak volume and resolution experienced when using traditional porous IEX particles for large molecule separations. In addition, the novel particle and surface chemistry delivers high sample loading capacities and component resolution while minimizing column fouling.
Multi-solvent blending Get the flexibility of multi-solvent blending with the bioQuaternary Solvent Manager (bioQSM), and blend four solvents in any combination or proportion. Expand to up to nine solvents with the optional and integrated solvent-select valve for even greater flexibility. Automated solvent compressibility allows you to run any solvent in any combination without loss in accuracy or precision.
Precise sampling that’s reliably quantitative The system’s flow-through-needle sample manager is accurate and precise with excellent sample recovery and ultra-low carryover, resulting in more reliable and reproducible results.
Versatile column management Support for analytical LC column dimensions up to 300 mm with capacity to automatically select between as many as 6 analytical columns. Equipped with independently controlled temperature zones, active pre-heating, and eCord tracking for each column.
Detection optimized for UPLC separations Any UPLC separation is not complete without a full line of innovative, ultra-low-dispersion detectors designed to maintain peak integrity. Waters offers the widest range of UPLC-optimized detectors – from optical to mass spectrometry – enabling you to meet multiple detection requirements for biological applications.
NEW columns for high resolution size-exclusion HPLC protein separations
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Laboratories around the world are converting to ACQUITY UPLC H-Class.
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