ポスター：プロセス開発向け統合プラットフォームにおける灌流培養プロセスの解析

Festival of Biologics Basel
October 9, 2023

Genedata Bioprocess^®は、細胞株構築ならびにプロセス開発においてワークフローの自動化とスループットの増大を可能にするバイオプロセス開発データ管理システムです。プロセス開発キャンペーンで収集された多種多様なデータをキャプチャするよう設計されています。

We have built and extended a bioprocess development data management and workflow system to support automated workflows and increase throughput in cell line and process development. The data model of the platform has been designed to capture the heterogeneous data collected during process development campaigns. The platform has been extended to track analytical samples, harvested fractions, and time-series data of perfusion processes at any scale. We enabled the automatic addition of process and analytical data via online, at-line, and offline instruments, and manually via data submission forms. Submitted data are also automatically processed, aggregated, and visualized. We present concrete use cases showing how the platform supports clone evaluation and process development when perfusion processes are applied. We demonstrate the barcoded sampling and analytics workflow along this process and show how online and offline process and product quality data are processed and visualized. We show how the platform enables the correlation of process parameters with key performance indicators of the processes (e.g., specific productivity) and the product quality attributes (e.g., aggregation, glycosylation profiles). The impact of raw material batch-to-batch variation is also illustrated. In addition, the registration of harvested fractions and handover to the downstream processing is presented.