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maXis II for Biopharma Analysis

maXis II for Biopharma Analysis
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maXis II for Biopharma Analysis • mAb Development made easy BioPharma Innovation with Integrity

maXis II: Unmatched Performance Determining the monoisotopic mass for large molecules (> 25 kDa) and related variants is essential for mAb developability assessments during early stage development. The maXis II UHR-QTOF mass spectrometer together with the SNAP-II deconvolution algorithm possesses an intrinsic edge for the rapid profiling of large proteins and their heterogeneities. Sub-unit characterization (e.g. de-amidation) using the power of True Isotopic Pattern (TIP) raw data True Isotopic Pattern (TIP) Asp30 or isoAsp30 The maXis II acquires True Isotopic Pattern (TIP) raw data that...

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The ‘de facto’ standard for biologics Mass spectrum of a heavy chain with resolved isotopes Mr mono (meas) = 50613.041 Da Mr mono (expected) = 50613.004 Da ∆Mr/Mr = 0.73 ppm Higher Order Analysis MaxEnt deconvolution spectrum measured in blue. Simulated mass spectrum in black. Increase speed to clinic with the maXis II: • Understand and predict PK properties of antibodies by thorough characterization of glycans • Accurately determine deamidation • Rapid drug-antibody ratio (DAR) analysis • Reduce downstream manufacturing risks • Monitor batch to batch variability The maXis II comes with...

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Superior Glycan Profiling Performance Glycosylation is a crucial quality attribute for many biopharmaceuticals, as small changes in glycosylation profiles can have significant impact on stability, efficacy and/or safety. Confidently determine: • Relative abundances (The most glycan IDs and Identifying, monitoring and controlling the glycosylation levels is key for successful biopharmaceutical development and the maXis II confidently addresses these key challenges in many pharmaceutical labs today at the intact, subunit, glycopeptide and released glycan level. • Composition (glycopeptide or...

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Increased Confidence in Released Glycan Analysis • Empirical spectra library comprising accurate mass and MS/MS spectra of 2AB and RapiFluor® labeled glycans (25 glycoproteins including most IgG subtypes and over 15 cell lines) • Optimized LC and MS acquisition method • Data processing with built-in expert knowledge. Scoring based on fragment intensities and quantitation of coeluting glycans • Report generation including MS and fluorescence based data with minimized user intervention • Workflow can be applied to regulated environments Sample Preparation • Enzymatic release of glycans from...

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The maXis II easily detects and quantifies micro-heterogeneities directly on intact antibodies including under native conditions. This makes the maXis II the perfect platform to rapidly develop assays for drug distribution and average drug loading (DAR) without waiting for HPLC methods to be established. Comparability with orthogonal methods and robustness makes it possible to validate these methods for GLP operations. Method Reproducibility Assessment Validation of drug distribution and DAR assay under native conditions on the maXis II UHR-QTOF • Interday • Intersite • Under GLP

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One software platform including features such as intact protein and sub-unit analysis or peptide screening and quantitation workflows, which routinely provide artifact free quantification with highest dynamic range, fully integrating LC-UV, MS and MS/MS data. Integrated data acquisition. Simple GUI for starting and monitoring acquisition runs. Predefined, customizable report formats, supports 21 CFR Part 11 requirements. Butterfly plots for easy comparison of chromatograms and spectra Top-Down sequencing using ETD tr*> WOWii IU. MMhaci N-lftiCoifcn) t-wrtafnM <i»ki ta*iwa W[l; V|t|...

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• 80,000 FSR (Full Sensitivity Resolution) with high intra-scan dynamic range • True Isotopic Pattern (TIP) not limited by space charge effects for accurate DAR analysis • SNAP-II algorithm for accurate monoisotopic mass determination for large biologics • Supports 21 CFR Part 11 • Electron Transfer Dissociation • Native mass spectrometry enabled • Glycan analysis with Glycofiler library For research use only. Not for use in diagnostic procedures. # Bruker Daltonik GmbH Bremen ■ Germany Phone +49 (0)421-2205-0 Fax +49 (0)421-2205-103 Bruker Daltonics Inc. Billerica, MA ■ USA Phone +1 (978)...

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