Genedata Selector 9.0 リリース：細胞・遺伝子治療における重要品質特性（CQA）評価を自動化

メジャーソフトウェアアップデートによって、バイオ医薬品研究開発機関の細胞・遺伝子治療開発の全工程における同一性・完全性・力価・安全性を確認するための次世代シーケンス（NGS）を用いた革新的なアッセイをGMP環境下で採用可能に

August 3, 2023
Basel, Switzerland

スイス・バーゼル、2023年8月3日－Genedataはこの日、高い安全性と効能の細胞・遺伝子治療を世界中の患者へ届けようと努める研究開発機関に対して品質管理の自動化サポートを提供するコラボレーション型End-to-endソリューションの最新バージョン「Genedata Selector^® 9.0」のリリースを発表しました。

Genedata Selector is an enterprise platform that automates the identification and monitoring of critical quality attributes during cell and gene therapy development and manufacturing. Equipped with out-of-the-box workflows named Playbooks, the platform enables scientists to perform data analyses accurately and efficiently, independent of data analysts. Bioinformaticians can include proprietary workflows for NGS data processing and analysis and make them available across an organization facilitating automation and improved process standardization. As a modular platform with sample management capabilities, Genedata Selector facilitates sample tracking and provides user-friendly decision-making tools that support in-depth analysis of pass/fail samples. 

Selector 9, the latest release, focuses on providing specialized analytical workflows for biotherapeutic characterization and adventitious agent detection to meet required regulatory standards. In particular, this release has eliminated data handling redundancies and further improved the interoperability of Genedata Selector, for example by enabling easy integration of proprietary Nextflow pipelines into the platform for NGS data processing. This enables users to benefit from best practices for developing innovative cell and gene therapy products. Finally, the tighter integration with high-performance computing environments enables Genedata Selector users to manage system resources while gaining scalability and power. 

Genedata Selector is fully compliant with FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. During CGT product development, biopharmaceutical R&D organizations gather large volumes of highly diverse experimental data, for which Genedata Selector provides a centralized location that integrates those data and connects them to their respective sample metadata. Teams involved in product development can easily access these data, to for example monitor changes in critical quality attributes and make data-informed decisions about which products should proceed in the manufacturing process. Additionally, Genedata Selector is validation-ready for deployment in GxP environments, and if required, Genedata can also provide computer system validation support.

Genedata CEO Othmar Pfannesは次のようにコメントしています。「Genedata Selector 9によって、革新的なバイオ医薬品研究開発機関が患者さんの人生を変える細胞・遺伝子治療製品を上市させるまでにかかる時間を短縮するという目標へ向けて、また大きな一歩を踏み出しました。Genedata Selectorの業界最高クラスの解析機能は、バイオファーマ業界でNGSを導入し、バイオプロセス開発および製造において製品品質の効率的なモニタリングを可能にします。Genedataは、カスタマーが最高品質のバイオ医薬品を効率的に開発できるよう、実験ワークフローの更なる加速と複雑なデータ解析プロセスの自動化へ投資を続けていきます。」