Expert software is the first element of plan to further develop the bioanalyser system into a compliance solution for customers in regulated environments
Agilent Technologies has introduced new software with compliance features that enable the Agilent 2100 bioanalyser 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 bioanalyser 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, comprising more than a quarter of all new drug approvals.
The Agilent 2100 bioanalyser, combined with the Protein 50 or Protein 200 Plus LabChip kits, provides a fast and easy method of analysing 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 now also provides a consolidated platform for all Agilent 2100 bioanalyser 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 2100 expert software is available now as part of the Agilent 2100 bioanalyser desktop (US$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 31 January 2004.
