Harnessing Sequencing for Digital QC & Impurity Intelligence to Build Actionable & Reproducible Oligonucleotide Manufacturing Control Strategies

• Identifying sequence-related variants that influence batch consistency and downstream complexity to better inform manufacturing control strategies
• Apply high-resolution variant profiling to anticipate impurity shifts during scale-up and tech transfer, to enable more predictable manufacturing
• Integrating sequencing data into comparability assessments to strengthen regulatory confidence across the product lifecycle

Speakers:

Shaimaa Ahmadeen

Scientific evaluation expert

Saudi FDA