Leveraging Next-Generation Sequencing for CMC of Gene and Cell Therapy Products

April 28, 2025

In the rapidly evolving field of cell and gene therapies (CGTs), Chemistry, Manufacturing, and Controls (CMC) is instrumental to ensure product quality, safety, and regulatory compliance. The development and production of CGTs present significant challenges, including shorter shelf life, manufacturing complexity, high costs, and Critical Quality Attributes (CQAs) assessment under stringent regulatory compliance. By leveraging the next-generation sequencing (NGS) technology, biopharmaceutical companies can address these challenges to produce high-quality CGTs that meet GMP requirements and clinical standards. For this to succeed, validated in-house platforms are required. However, successful validation demands careful consideration of variability in methods, instruments and protocol standardization, robust data handling, and adherence to regulatory compliance.

Genedata Selector^® is an enterprise software platform that automates and accelerates complex NGS data analysis workflows. It establishes a single source of truth across NGS instruments and assays. Genedata also supports biopharma companies in their validation and CMC challenges