RSQ-016 - Regulatory CMC submission challenges and recommendations for synthetic oligonucleotides and RNA therapies

• At: Copenhagen (Denmark) (2025)
• Type: Poster
• Poster code: RSQ-016
• By: AGNIHOTRY, Jyotsna (School of Pharmaceutical Sciences, Jaipur National University, India)
• Co-author(s): Ms Jyotsna Agnihotry (School of Pharmaceutical Sciences, Jaipur National University, Jaipur, India)
  Dr Dinesh K. Upadhyay (School of Pharmaceutical Sciences, Jaipur National University, Jaipur, India)
  Dr Sandeep Arora (School of Pharmaceutical Sciences, Amity University, Punjab, India)
  
• Abstract:

  Introduction:
  Synthetic oligonucleotides and RNA-based therapies have emerged as transformative modalities in modern medicine. These therapies, including antisense oligonucleotides, siRNAs, aptamers, and mRNAs, offer highly targeted mechanisms of action. Despite their clinical promise, regulatory Chemistry, Manufacturing, and Controls (CMC)..

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