AGILENT TECHNOLOGIES’ NEW SOFTWARE FOR AGILENT 2100 BIOANALYZER
PALO ALTO, Calif., November 03, 2003 — Agilent Technologies Inc. (NYSE: A) today introduced new software with compliance features that enable the Agilent 2100 bioanalyzer to be used for the development and manufacture of protein-based therapeutics in regulated environments, such as the pharmaceutical and biotechnology industries. It also offers significant improvements in usability, data analysis, results handling and reporting.
The new Agilent 2100 expert software is the first element of Agilent’s plan to further develop the Agilent 2100 bioanalyzer system into a compliance solution for customers in regulated environments, specifically those involved in the QA/QC and manufacturing of antibodies and other protein pharmaceuticals. Since 2000, regulators in Europe and North America have approved 64 protein-based drugs(1), comprising more than a quarter of all new drug approvals. The Agilent 2100 bioanalyzer, combined with the Protein 50 or Protein 200 Plus LabChip® Kits, provides a fast and easy method of analyzing protein size, concentration, purity and integrity.
As part of this introduction, Agilent is providing software support for installation qualification (IQ) and operational qualification/performance validation (OQ/PV) in a dedicated validation context. Agilent is also introducing IQ and OQ/PV services and “Declarations of Conformity” for reagents and chips. Declarations of Conformity state that during final verification, a product’s functional characteristics are individually tested for conformance with the manufacturer’s internal specifications.
Agilent next plans to introduce a security software pack, which will enable full 21 CFR Part 11 compliance for electronic signatures, audit trails and user authentication.
The software introduced today also provides a consolidated platform for all Agilent 2100 bioanalyzer assays. These assays, used to assess the quality and quantity of DNA, RNA and proteins, as well as monitor cell parameters, had previously required two dedicated software modules. The software’s other enhancements include:
- improved integrator and manual integration capabilities;
- normal and advanced user modes;
- color-coded result flagging tool;
- enhanced reporting, export and printing functions; and
- customizable result tables and gel-like images.
US Pricing and Availability
The 2100 expert software is available now as part of the Agilent 2100 bioanalyzer desktop ($19,855) or laptop ($21,400) system. An electrophoresis set ($4,738) and/or a flow cytometry set ($6,180) may need to be purchased depending on the application. The revision is also available free of charge to all existing customers until January 31, 2004.
About the Agilent 2100 Bioanalyzer System
The Agilent 2100 bioanalyzer is the market-leading microfluidics-based system for automated quality control, sizing and quantification of nucleic acids or proteins, and simple flow cytometric analyses. The system uses micro-fabrication technology to transfer laboratory processes onto miniature glass chips. Integrating sample preparation, fluid handling and biochemical analysis, the system offers several advantages over traditional gel electrophoresis in terms of speed, automation, sample use and data quality.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global technology leader in communications, electronics and life sciences. The company’s 35,000 employees serve customers in more than 110 countries. Agilent had net revenue of $6 billion in fiscal year 2002. Information about Agilent is available on the Web at www.agilent.com.
