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Related Experiment Video

Updated: Dec 22, 2025

Protocol for the Solid-phase Synthesis of Oligomers of RNA Containing a 2'-O-thiophenylmethyl Modification and Characterization via Circular Dichroism

Protocol for the Solid-phase Synthesis of Oligomers of RNA Containing a 2'-O-thiophenylmethyl Modification and Characterization via Circular Dichroism

Published on: July 28, 2017

Technical Considerations for Use of Oligonucleotide Solution API.

Jale Muslehiddinoglu¹, Robert Simler², Malcolm L Hill³

¹Janssen, Beerse, Belgium.

Nucleic Acid Therapeutics

|May 8, 2020

Summary

This summary is machine-generated.

Manufacturing oligonucleotides can skip the solid active pharmaceutical ingredient (API) isolation step. This approach, similar to biologics, focuses on API solution stability and other factors for efficient drug product formulation.

Keywords:

lyophilization oligonucleotides solution API

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Area of Science:

Pharmaceutical Manufacturing
Oligonucleotide Therapeutics
Drug Product Development

Background:

Traditional oligonucleotide manufacturing involves isolating the active pharmaceutical ingredient (API) as a solid via lyophilization before formulation.
This solid API is then dissolved to create the final aqueous drug product.
This process is analogous to the established manufacturing of large molecules (biologics), where API isolation is not always required.

Purpose of the Study:

To provide technical considerations for formulating oligonucleotide APIs directly from solution.
To explore the feasibility of eliminating the solid API isolation step in oligonucleotide manufacturing.
To evaluate the advantages and disadvantages of solution versus powder API for oligonucleotide drug substances.

Main Methods:

Discussion of technical considerations for oligonucleotide API in solution.
Analysis of solution stability as the primary factor.
Consideration of additional factors including viscosity, concentration, end-to-end manufacturing, microbiological control, packaging, and storage.

Main Results:

The study outlines key technical factors for using oligonucleotide API in solution.
Solution stability is identified as the critical parameter for this manufacturing approach.
Other crucial aspects like viscosity, concentration, and process controls are also detailed.

Conclusions:

Eliminating solid API isolation for oligonucleotides is a viable manufacturing strategy.
Careful evaluation of solution stability and other process parameters is essential.
This approach offers potential advantages for oligonucleotide drug product development and manufacturing.