Octet application "Assays under GxP Regulatory Environment"
By using tools compliant with GxP and simple operations, we enable productivity improvements in the analysis development and quality control of pharmaceuticals under regulatory environments.
As a regulatory requirement, biopharmaceuticals must be QC tested using methods that are robust and appropriately qualified and validated under GMP conditions. The Octet system for analyzing biomolecular interactions is a reliable system that facilitates method development for in-process testing and lot release testing, and it can be easily transferred to QC. Due to its ease of use and high throughput characteristics, it can achieve up to 40 times the productivity of ELISA and up to 16 times that of SPR equipment in specific GMP applications. ■ The Octet CFR software and FB server functionality maintain secure and traceable electronic records. ■ The IQ/OQ/PQ package guarantees the required conditions and operations. ■ Validation support services for software and biosensors are provided. *For more details, please refer to the PDF materials or feel free to contact us.
- Company：ザルトリウス・ジャパン
- Price：Other
