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Session 4 Track 3: Advance Enzymatic Oligonucleotide Manufacturing: From Scalable Chemistry to Regulatory CMC Readiness
Session Chair(s)
Dominik Altevogt, PHD
Director Regulatory Affairs CMC
Novartis, Switzerland
As therapeutic oligonucleotide modalities expand in complexity and scale, manufacturers are exploring enzymatic approaches to address limitations of conventional solid phase synthesis. This session provides a forward-looking discussion of emerging enzymatic manufacturing concepts, with a focus on how these technologies may impact impurity profiles, scalability, and overall product quality. Speakers will examine key scientific and CMC considerations relevant to enzymatic oligonucleotide production and discuss how potential benefits and risks could be evaluated within established regulatory frameworks. The session aims to foster dialogue between industry and regulators on expectations, open questions, and areas where further alignment or data generation may be needed.
Learning Objective : At the conclusion of this session, participants should be able to: - Evaluate, advantages and limitations of large scale enzymatic oligo synthesis vs. conventional solid phase synthesis
- Assess, readiness for regulatory acceptance of alternative synthesis routes
- Determine when transitioning synthesis technologies can improve long term scalability and manufacturing flexibility.
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