Capped Oligonucleotide Primers for Homogeneous 5'-Capped RNA Synthesis

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Solution Overview

Problem

Current methods for synthesizing 5'-capped RNAs are laborious, inefficient, costly, and result in low yields with significant production of heterogeneous products, requiring additional enzymatic steps for Cap 1 and Cap 2 structures, and are difficult to control, especially in large-scale manufacturing.

Innovation Solution

A complex comprising an initiating capped oligonucleotide primer with a specific structure and a polynucleotide template is used, allowing for co-transcriptional synthesis of 5'-capped RNAs, reducing bi-directional initiation and eliminating the need for additional enzymatic reactions to incorporate Cap 1 and Cap 2 structures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If conventional enzymatic capping methods are used to synthesize 5'-capped RNAs, then the Cap structure can be introduced, but the process becomes laborious, inefficient, and costly with low yields

Engineering Contradiction:
Improvesynthesis efficiencyVSAvoidprocess complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The Cap structure is pre-installed on the initiating oligonucleotide primer before transcription begins. This preliminary action eliminates the need for subsequent enzymatic capping steps, directly resolving the contradiction by improving synthesis efficiency while reducing process complexity.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The capping step is extracted and removed from the transcription process. By using a pre-capped primer, the complex enzymatic capping procedure is completely eliminated, leaving only the essential transcription step, thus improving efficiency and simplifying the process.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If additional enzymatic steps are performed to incorporate Cap 1 and Cap 2 structures, then translation efficacy and nuclease stability are improved, but the process becomes more laborious and difficult to control

Engineering Contradiction:
Improvetranslation efficacyVSAvoidease of control
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The 2'-O-methylation modification is pre-installed on the primer nucleotides before transcription. This preliminary action ensures high translation efficacy and nuclease stability while avoiding the need for additional enzymatic methylation steps, thereby maintaining ease of operation and control.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The enzymatic methylation steps are extracted and removed from the process. By using pre-modified primers with Cap 1 and/or Cap 2 structures, the complex multi-step enzymatic process is replaced with a single transcription step, improving both reliability and ease of control.

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If large-scale synthesis is performed using conventional methods, then production capacity increases, but the process becomes difficult to control and yields heterogeneous products

Engineering Contradiction:
Improveproduction capacityVSAvoidproduct homogeneity
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The Cap structure and modifications are pre-installed on the primer before large-scale transcription. This ensures that every RNA molecule produced inherits the correct structure from the beginning, maintaining high product homogeneity even at large production scales.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The synthesis process is segmented into two independent stages: (1) preparation of pre-capped and pre-modified primers, and (2) large-scale transcription. This segmentation allows optimization of each stage independently, ensuring product homogeneity while achieving high production capacity.

Inventive Principle:
Principle #1Segmentation

4Manufacturing precision

If bi-directional initiation is reduced by using symmetric mCAP analogs, then product homogeneity improves, but the cost increases due to large molar excess required

Engineering Contradiction:
Improveproduct homogeneityVSAvoidreagent consumption
Core Design Contradiction:
Manufacturing precisionVSQuantity of substance

Solution Approach 1:

The Cap structure is pre-installed on the initiating primer with defined sequence and structure. This eliminates the need for symmetric mCAP analogs and large molar excesses, achieving both product homogeneity and reduced reagent consumption.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Instead of using symmetric mCAP analogs, the invention employs an asymmetric pre-capped oligonucleotide primer with a specific sequence (e.g., 5'-Cap-pGpG or 5'-Cap-pGpU). This asymmetric design provides directional initiation with high homogeneity while eliminating the need for large reagent excess.

Inventive Principle:
Principle #4Asymmetry

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This method achieves higher yields of 5'-capped RNAs with reduced costs and labor, minimizing heterogeneous products, and allows for the synthesis of RNAs with modified nucleosides and affinity tags, suitable for various biological and therapeutic applications.

Implementation Method 1

transcription by the RNA polymerase of the polynucleotide template

Methodology Applied
Scientific EffectTranscription:

Implementation Method 2

B1 in the initiating capped oligonucleotide primer is complementary to the first nucleoside base and B2 is complementary to the second nucleoside base

Methodology Applied
Scientific EffectHybridization:

Data Source

PatentEP4424835B1Compositions and methods for synthesizing 5'-capped rnas
Publication Date: 2026.01.21 TRILINK BIOTECH LLC
  • EP4424835B1 patent drawingFigure 1~2
  • EP4424835B1 patent drawingFigure 3~5
  • EP4424835B1 patent drawingFigure 6~7

AI summary

A complex comprises an initiating capped oligonucleotide primer and a polynucleotide template, the initiating capped oligonucleotide primer comprising the following structure: wherein: B1 is adenine, B2 is guanine, R1 is OH, R2 is OH, and R3 is O-methyl, wherein the polynucleotide template comprises a first nucleoside base at transcription template position +1 and a second nucleoside base at transcription template position +2, and wherein B1 is complementary to the first nucleoside base and B2 is complementary to the second nucleoside base. In a primer per se, B1 is N6-methyladenine, and methods of synthesizing RNA use a primer in which B1 is adenine or N6-methyladenine.