ポスター：NGSを活用したCMC戦略 - バイオ医薬品の製造における品質とコンプライアンスの向上

September 16, 2025

次世代シーケンス（NGS）技術は、重要品質特性（CQA）の包括的な評価を可能にし、バイオ医薬品のCMCを革新へ導いています。バリデーション対応のNGSプラットフォームをインハウスで導入し、堅牢なデータ管理と規制準拠により、安全で一貫性のあるGMPグレードの治療薬を迅速に届けることが可能になります。

In the rapidly evolving field of biological drug products, Chemistry, Manufacturing, and Controls (CMC) is instrumental in ensuring product quality, safety, and regulatory compliance. Biopharmaceutical companies are increasingly adopting next-generation sequencing (NGS)-based assays to support their starting material (like cell line or vector) development and characterization. Biological drug modalities, like  antibody-therapies must be rigorously characterized to meet stringent quality standards. 

To mitigate manufacturing risks, such as contaminations or genetic instabilities, and to ensure regulatory compliance, it is essential to characterize Critical Quality Attributes (CQAs) such as identity, integrity, and purity of the production cell line. By leveraging NGS technology, biopharmaceutical companies can enhance the reliability and consistency of their manufacturing processes, delivering safer, more effective, GMP-grade therapies to patients faster. For this to succeed, validated in-house NGS platforms are required. Successful validation demands careful control of method variability, instruments and protocol standardization. Furthermore, robust data handling, and adherence to regulatory compliance is essential. 

Genedata Selector^® is an enterprise software platform that automates and accelerates complex NGS data processing, analysis, interpretation and decision making processes, supporting companies in overcoming CMC challenges in biologics production.