Whitepaper
From Clinical to Commercial Supply
Top Six Considerations for Taking Oligonucleotide Therapies from Clinical to Commercial Supply
Explore six considerations for commercial oligonucleotide supply, spanning regulatory engagement, process understanding and lifecycle management.
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About this whitepaper
Taking an oligonucleotide therapy from clinical development to commercial supply involves more than increasing production scale. Decisions about specifications, impurity control, process validation and scale-up shape commercial readiness. This guide discusses six considerations for planning that transition and managing methods and processes after launch.
What you’ll learn
- Early regulatory engagement before process performance qualification (PPQ) and commercial validation.
- Defensible specifications and suitable impurity control.
- Early CDMO involvement to support planning, scale-up and execution.
- Robust process design and characterization.
- Scale-up readiness for commercial manufacturing.
- Method and process lifecycle management after launch.
Who is it for?
CMC, manufacturing, quality and program teams preparing an oligonucleotide therapy for commercial supply.