FPO. BioPharma Compass 2.0. Innovation with Integrity. Accelerate Biopharmaceutical Analysis. Software

Transcription

1 FPO BioPharma Compass 2.0 Accelerate Biopharmaceutical Analysis Innovation with Integrity Software

2 Developed with the Biopharma Industry Award-winning biopharmaceutical analysis platform Commercial and regulatory pressures are having significant impact on the analytical workload of many discovery and development groups. The ability to provide accurate knowledge quickly and confidently without fear of omissions is key. Due to its versatility, Mass Spectrometry (MS) has evolved into the go-to technique for addressing a multitude of characterization and process development challenges. BioPharma Compass* software provides biopharmaceutical scientists working in drug discovery and development with a wizard-driven platform for automated MS data acquisition and processing, together with flexible and powerful data analysis and reporting tools, all integrated within a project-based compliance-ready framework. BioPharma Compass is unique in its ability to seamlessly unify MALDI-TOF/ TOF and ESI UHR-QTOF, as well as fluorescence detection (FLD) and UV data and transform it into meaningful knowledge. *Voted Best New Technology at the 18th Annual Land O Lakes Pharmaceutical Bioanalytical Conference 2017 From Discovery to GxP Taking full advantage of the benefits of Bruker s ultra-high resolution QTOF, the maxis II, and the market-leading MALDI-TOF/TOF platforms, BioPharma Compass 2.0 further extends Bruker s expertise in biopharmaceutical characterization. It provides users with customizable workflows for common biopharmaceutical applications. This powerful suite of tools automates the processes of acquiring, analyzing and reporting data all in a way that supports 21 CFR Part 11 compliance. Bioharma Compass is a wizard-driven workflow based platform, suitable for experts and novices alike. Methods developed in a non-regulated environment can be lockeddown for routine deployment. The customizable workspace permits rapid view into key features, including system status monitoring, method development, and data review, all from the comfort of your office PC.

3 Intact Protein Profiling and Verification Intact Protein Analysis: Glycoforms and Heterogeneity Screening The ultra-high resolution available on Bruker s maxis II UHR QTOF has been proven to be uniquely beneficial to the identification of low level protein isoforms in mab characterization 1. With Bruker's patented SNAP algorithm and True Isotopic Pattern (TIP TM ) calculation, the automatic assignment of molecular formulae of monoisotopic masses up to 50kDa with sub-ppm precision is possible. The cosine similarity score, which provides an automated quality assessment, simplifies batch comparison. Figure 1: Use the leading subunit workflow with BioPharma Compass to automatically generate a screening list based on the protein sequence provided. In this example the NIST mab IdeS digest fragments were LC separated (280 nm trace shown). The selected peak (red) was averaged (spectrum not shown) and underwent charge deconvolution (blue), overlayed with the theoretical isotope pattern (red). SNAP Monoisotopic Mass Calculation readily detects microheterogeneity at the domain level (Fc/2-KG1F). Cosine Similarity Calculation with color coded pass/fail criteria for rapid batch comparison. Top-down Protein Sequencing: Sequence Variant Localization Bruker's market-leading MALDI-TOF/TOF platforms in combination with BioPharma Compass provide rapid top-down, middle down and middle-up protein analysis. The Sequence Validation Percentage (SVP) in combination with N/C terminal fragment ion coverage map readily provides confirmation and localization of sequence variants, mis-incorporations, or other quality attributes 2. Figure 2: The color-coded table shows the ranked proteoform candidates for the cetuximab Fd fragment after N88 deglycosylation analysis. The correct sequence with N-term pyro-glu and N88-deamidation ranked best (SVP =100%) and confirmed by the N/C-terminal fragment ion coverage map.

4 Simple. Yet Versatile and Powerful Glycans Correct primary structure assessment Correct primary structure assessment and extensive glyco-profiling of cetuximab and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI middle-down mass spectrometry and bottom-up techniques ESI and MALDI mass spectrometry techniques Daniel Ayoub, 1, * Wolfgang Jabs, 2 * Anja Resemann, 2 Daniel Waltraud Ayoub, Evers, 1, Wolfgang 2 Catherine Jabs, Evans, 2 Anja 3 Laura Resemann, Main, 4 2 Carsten Baessman, 2 Elsa Wagner-Rousset, 1 Detlev Suckau Waltraud Evers, 2 Catherine Evans, 3 Laura Main, 4 2 and Alain Beck 1,* Carsten Baessman, 2 Elsa Wagner-Rousset, 1 Detlev Suckau 2 and 1 Centre Alain d'lmmunologie Beck 1 Pierre Fabre; St Julien-en-Genevois, France; 2 Bruker Daltonik GmbH; Bermen, Germany; 3 Bruker Daltonics GmbH; Fällanden, Switzerland; 4 1 Bruker Daltonics Ltd; Coventry, UK Centre d'lmmunologie Pierre Fabre; St Julien-en-Genevois, France; 2 Bruker Daltonik GmbH; Bermen, Germany; 3 Bruker Daltonics GmbH; Fällanden, Keywords: Switzerland; cetuximab, 4 Bruker sequence, Daltonics Ltd; mass Coventry, spectrometry, UK glycosylation, biosimilar Keywords: cetuximab, sequence, mass spectrometry, glycosylation, biosimilar REPORT Correct primary structure assessment Full validation of therapeutic antibody and extensive glyco-profiling of cetuximab sequences by middle-up mass measurements by a combination of intact, middle-up, and middle-down middle-down and protein bottom-up sequencing ESI and MALDI Anja mass Resemann, spectrometry Wolfgang Jabs, techniques Anja Wiechmann, Elsa Wagner, Olivier Colas, Waltraud Evers, Eckhard Belau, Lars Vorwerg, Daniel Ayoub, 1, * Wolfgang Jabs, 2 * Anja Resemann, 2 Catherine Evans, Alain Beck and Detlev Suckau Waltraud Evers, 2 Catherine Evans, 3 Laura Main, 4 Carsten Baessman, 2 Elsa Wagner-Rousset, 1 Detlev Suckau ISSN: (Print) (Online) Journal homepage: and Alain Beck 1 2,* 1 Centre d'lmmunologie Pierre Fabre; St Julien-en-Genevois, France; 2 Bruker Daltonik GmbH; Bermen, Germany; 3 Bruker Daltonics GmbH; Fällanden, Switzerland; 4 Bruker Daltonics Ltd; Coventry, UK Keywords: cetuximab, sequence, mass spectrometry, glycosylation, biosimilar REPORT 1) Ayoub et al., mabs (2013), 5:5, Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact,middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques 2) Resemann et al., mabs (2016) 8:2, Full validation of therapeutic antibody sequences by middle-up mass measurements and middle-down protein sequencing

5 Peptide Mapping for Sequence Confirmation and Attribute Identification BioPharma Compass simplifies viewing and reporting peptide mapping results. Clear overview and detailed validation screens are available for high quality sequence confirmation and post-translational modifications (PTM) identification. Figure 3: Tryptic digest analysis of the NIST mab: LC (UV or BPC) dataset confirming expected peptides, highlighting unexpected peptides Peptide Screening - Attribute Monitoring and Quantification With BioPharma Compass it is easy to seamlessly generate screening lists from peptide mapping results for comparability assessments, quality attribute monitoring and quantification (using MS or optical chromatograms). Figure 4: Quantitative comparison of oxidation of the NIST mab after treatment under different oxidative stress conditions. Figure 5: Prequalified peptides from the peptide mapping of the tryptic digest of the NIST mab were used to quantify oxidation hotspots.

6 Workflow Selection Automated A and Processi Bruker Blue Ribbon Menu allows control of workflowspecific appearance and easy initiation of analyses Project View with all associated files Main View with identified peptides / proteins Mass Spec View / Chromatogram View Protein sequence information

7 cquisition ng Reporting Data Review

8 Bruker Daltonics is continually improving its products and reserves the right to change specifications without notice. BDAL , Accelerate Biopharmaceutical Analysis Summary Integrated biopharmaceutical workflows from acquisition to reporting for automated characterization, identity confirmation, attribute monitoring, comparative quantitative assessments Protein Screening: Intact, reduced, subunits, including glycan profiles Top-Down Protein Sequencing (ESI and MALDI) Peptide mapping and screening Full suite of ESI and MALDI data processing tools plus UV and FLD support; includes the complete ProteinScape functionality, e.g. Protein database searches Glycan database searches Glycopeptide analysis Protein quantitation Simple user interface for control and navigation including linked data and results views, customizable color-coded pass/fail criteria for rapid data review Integrated reporting engine with configurable, workflow-specific report layouts Regulatory Toolkit for support of 21 CFR Part 11 compliance Order Information BioPharma Compass BioPharma Compass 2.0 Server - Server Hardware - 5 Floating Access Licenses - Client installation on individual client PCs (HW not included) BioPharma Compass 2.0 Workstation - Workstation Hardware - Single User Access License - Server and Client on the same computer Software Upgrade from ProteinScape SW-Upgrade BioPharma Compass 2.0 Server SW-Upgrade BioPharma Compass 2.0 Workstation Upgrade from BioPharma Compass 1.x (incl. Hardware) BioPharma Compass 2.0 Server for BPC 1.X Customers BioPharma Compass 2.0 Workstation for BPC 1.X Customers Functionality for regulated laboratories BioPharma Compass 2.0 Regulatory Toolkit Bruker Daltonik GmbH Bremen Germany Phone +49 (0) Fax +49 (0) Bruker Daltonics Inc. Billerica, MA USA Phone +1 (978) Fax +1 (978) Biopharma Compass 2.0 ms.sales.bdal@bruker.com - Scan QR Code for more details