Case study: Scale siRNA manufacturing efficiently via a fragment and enzymatic ligation approach

As demand for siRNA therapeutics continues to grow, manufacturers face increasing pressure to deliver larger quantities of drug substance efficiently, economically, and sustainably. This case study explores how Bachem and Codexis are advancing an alternative manufacturing approach that combines short-fragment synthesis with enzymatic ligation to improve process efficiency, scalability, and manufacturing economics while maintaining product quality comparable to conventional synthesis methods.

Using vutrisiran as a model siRNA, the study demonstrates how enzyme and fragment design together with innovative and scalable manufacturing technologies can achieve high ligation efficiencies, simplify purification, and support multi-kilogram GMP production. The result is a flexible manufacturing strategy that helps customers address scale-up challenges and prepare for increasing commercial demand.

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