Skip to main content
Loading

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