NGS-Powered CMC Strategies: Enhancing Quality and Compliance in Biologics Manufacturing

September 16, 2025

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.