ProteOn™ XPR36 System Regulatory Tools

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Overview

Tools are available with the ProteOn XPR36 system
to facilitate regulatory compliance in protein interaction analysis experiments in drug discovery and
development workflows.

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Description

Description

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

Ordering

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items

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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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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
176-4200_tn.jpg
1764200
Regulatory tools, includes ProteOn Manager software, ProteOn IQ/OQ software, ProteOn OQ kit (#176-4220)
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1764220
Instrument performance verification and validation kit for the ProteOn XPR36 system, includes ProteOn OQ kit 1 and OQ kit 2, GLC sensor chip

Documents

Documents

Number Description Options
6550
Building New Anti-HIV Molecules with Bio-Rad’s ProteOn XPR36 System, Rev A
6476
ProteOn Success Guide, Rev A
5679
Applications of the ProteOn GLH Sensor Chip: Interactions Between Proteins and Small Molecules, Rev A
5540
Screening, Ranking, and Epitope Mapping of Anti-Human IL-9 Supernatants, Rev A
5449
Applications of the ProteOn NLC Sensor Chip: Antibody-Antigen, DNA-Protein, and Protein-Protein Interactions, Rev B
5358
Mechanisms of Protein-Protein Binding: Double-Mutant Cycle Analysis Using the ProteOn XPR36 System, Rev A
5368
Anaylsis of Multiple Protein-Protein Interactions Using the ProteOn XPR36 Protein Interaction Array System, Rev B
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
5360
Rapid and Detailed Analysis of Multiple Antigen-Antibody Pairs Using the ProteOn XPR36 Protein Interaction Array System, Rev A
3172
Rapid and Efficient Determination of Kinetic Rate Constants Using the ProteOn XPR36 Protein Interaction Array System, Rev B
5412
Antibody Characterization and Development: ProteOn XPR36 Protein Interaction Array System Application Guide, Rev C
5413
ProteOn XPR36 Hardware Product Information Sheet, Rev B
5410
ProteOn Protocol Development Kits Product Information Sheet, Rev B
5404
ProteOn™ Sensor Chips Product Information Sheet, Rev F
5390
ProteOn XPR36 Protein Interaction Array System Brochure, Rev D
5409
Protein Interaction Analysis Ordering Information Sheet, Rev E
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
6414
ProteOn™ XPR36 Experimental Design and Application Guide, Rev B