Ensuring Robust CMC & Process Development Strategies for Scalable and Regulatory-Compliant Oligonucleotide Manufacturing
26 Jun 2025
CMC & Process Development
-
Optimizing process characterization and scalability by addressing purification, yield, and consistency challenges in oligonucleotide production
-
Understanding regulatory expectations and analytical standards and meeting evolving FDA and EMA guidelines for impurity profiling, mass spectrometry, and release testing
-
Addressing manufacturing bottlenecks overcoming synthesis, formulation, and stability challenges to ensure seamless transition from clinical to commercial scale