ProteOn™ XPR36 System Regulatory Tools

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ProteOn XPR36 System Regulatory Tools


Tools are available with the ProteOn XPR36 protein interaction array system to facilitate regulatory compliance in the drug discovery and development workflows. ProteOn Manager software, Security Edition, and the ProteOn XPR36 installation qualification/operation qualification (IQ/OQ) kit assist the user in adhering to the good practices rulings observed by the pharmaceutical industry. These rulings require procedural (notification, training, and operational), administrative, and technical (software-related) control changes.

ProteOn Manager Software, Security Edition
New compliance features enable the user to turn on security features that comply with U.S. FDA 21 CFR Part 11 regulations. Features of the Security Edition software include audit trails, electronic signatures, data validation, user logins and permissions, and closed-system security. Signatures can be verified, ensuring data consistency within the instrument.

ProteOn XPR36 IQ/OQ Kit
The ProteOn XPR36 IQ/OQ kit is designed to test critical system functions and to ensure the reliability and consistency of system performance. Key features include:

  • Intuitive wizard-driven software
  • Printable electronic reports for document control
  • Electronic log of IQ/OQ and test results
  • Ready-to-use reagents
  • Sensor chip for testing system performance with walk-away unattended operation
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ProteOn XPR36 Regulatory Tools Package

1764225
Regulatory tools, includes 1-user license for ProteOn Manager software, security edition (#176-0210), ProteOn XPR36 IQ/OQ kit (#176-4200)

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ProteOn Manager™ Software, Security Edition

1760210
1-user license, security edition software for ProteOn XPR36 instrument control, allows U.S. FDA 21 CFR Part 11 compliance, CD-ROM, includes HASP key

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ProteOn XPR36 Installation Qualification/Operation Qualification (IQ/OQ) Package

1764200
Regulatory tools, includes ProteOn Manager software, ProteOn IQ/OQ software, ProteOn OQ kit (#176-4220)

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ProteOn Operation Qualification Kit

1764220
Instrument performance verification and validation kit for the ProteOn XPR36 system, includes ProteOn OQ kit 1 and OQ kit 2, GLC sensor chip

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Number Description Options
6550 Building New Anti-HIV Molecules with Bio-Rad’s ProteOn XPR36 System, Rev A Click to download
6476 ProteOn Success Guide, Rev A Click to download
5679 Applications of the ProteOn GLH Sensor Chip: Interactions Between Proteins and Small Molecules, Rev A Click to download
5540 Screening, Ranking, and Epitope Mapping of Anti-Human IL-9 Supernatants, Rev A Click to download
5449 Applications of the ProteOn NLC Sensor Chip: Antibody-Antigen, DNA-Protein, and Protein-Protein Interactions, Rev B Click to download
5358 Mechanisms of Protein-Protein Binding: Double-Mutant Cycle Analysis Using the ProteOn XPR36 System, Rev A Click to download
5368 Anaylsis of Multiple Protein-Protein Interactions Using the ProteOn XPR36 Protein Interaction Array System, Rev B Click to download
5367 Rapid Optimization of Immobilization and Binding Conditions for Kinetic Analysis of Protein-Protein Interactions Using the ProteOn™ XPR36 Protein Interaction Array System, Rev A Click to download
5360 Rapid and Detailed Analysis of Multiple Antigen-Antibody Pairs Using the ProteOn XPR36 Protein Interaction Array System, Rev A Click to download
3172 Rapid and Efficient Determination of Kinetic Rate Constants Using the ProteOn XPR36 Protein Interaction Array System, Rev B Click to download
5412 Antibody Characterization and Development: ProteOn XPR36 Protein Interaction Array System Application Guide, Rev C Click to download
5413 ProteOn XPR36 Hardware Product Information Sheet, Rev B Click to download
5410 ProteOn Protocol Development Kits Product Information Sheet, Rev B Click to download
5404 ProteOn™ Sensor Chips Product Information Sheet, Rev F Click to download
5538 Analyzing Protein Interactions With the ProteOn XPR36 Protein Interaction Array System, Rev D Click to download
5390 ProteOn XPR36 Protein Interaction Array System Brochure, Rev D Click to download
5409 Protein Interaction Analysis Ordering Information Sheet, Rev E Click to download
5434A ProteOn XPR36 Protein Interaction Array System Folder. (Contains bulletins 3172, 5358, 5360, 5367, 5368, 5390, 5404, 5409, 5410, 5413, 5538, and 5465 DVD, depending on availability)
6449 Novel Liposome-Capture Surface Chemistries to Analyze Drug-Lipid Interaction using the ProteOn XPR36 System, Rev A Click to download
6414 ProteOn™ XPR36 Experimental Design and Application Guide, Rev B Click to download

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