At Agilent Technologies in Denmark, ensuring data integrity is paramount. The Agilent team knew that whatever analytical instrument they chose needed to meet the required specifications of ISO standards and general Good Laboratory/Manufacturing Practices (GxP). More specifically, they needed to be able to adjust for lot-to-lot variation and ensure that their mono-clonal and poly-clonal antibodies performed as specified. Their first step to accurate validation involved using ForteBio Streptavidin (SAX) biosensors to capture the antigen to give both information on specific binding rates and specificity. Their second step was to find and implement an analytical instrument with quality software for QC testing.
Our solution was the Octet RED96e part 11 CFR21 (GxP) version for QC testing. The Octet CFR software features secure, traceable, electronic record keeping that enable compliant data acquisition and data analysis in laboratories working under GxPand 21 CFR Part 11 regulations.
“The GxP version of the Octet software enables that templates can be locked for modification and that all analysis settings can be monitored and documented. The templates are retired from our quality system and all raw data is served on an internal server where it is not possible to change files unless they are renamed, nor is it possible to delete files. Thereby, the GxP software ensures that our data integrity is secured.” - Rikke Svava-Olsen
ForteBio’s high-precision streptavidin (SAX) biosensors, intended for use with biotinylated ligands, have been developed to ensure minimal lot-to-lot variations in ligand immobilization.
The 8-channel Octet systems perform quantitation of 96 samples in 32 minutes and kinetic screening of 64 samples in 1.5 hours. Analysis can be done using a single channel or up to eight channels, enabling flexibility in sample throughput based on need. An optional microplate evaporation cover that minimizes losses in sample volume is available with the Octet RED96e.
The result for Agilent was a complete qualification, validation, and support solution that ensures compliance in the regulatory space, while allowing for rapid development, optimization, and validation of assay methods.
“All in all, the Octet provides us with the ability to make fast QC tests, with high accuracy and precision and with good GDP quality.” – Rikke Svava-Olsen
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