Cell-Free DNA Mini-Circle Synthesis via Rolling Circle Amplification

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Solution Overview

Problem

Current methods for generating high-quality circular nucleic acids for therapeutic applications are limited by contamination risks, laborious purification processes, and low transformation efficiencies, particularly due to the rapid degradation of linear DNA molecules by nucleases and the complexity of converting concatamers to circular forms.

Innovation Solution

A cell-free system using rolling circle amplification and site-specific recombination proteins like Cre recombinase to generate circular nucleic acids from templates engineered with recombination sites, such as loxP sites, allowing for efficient conversion of tandem repeat sequences into circular forms without bacterial contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If linear DNA molecules are used for therapeutic applications, then they are easier to synthesize, but they are rapidly degraded by nucleases limiting their use

Engineering Contradiction:
Improveease of synthesisVSAvoidstability against nuclease degradation
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The linear DNA is segmented into multiple smaller linear fragments through controlled partial digestion or design, which are then circularized individually. This segmentation allows each fragment to be more stable while maintaining ease of synthesis through modular assembly

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of attempting to stabilize linear DNA directly, the invention inverts the approach by converting the linear DNA into circular form after synthesis. The circularization transforms the unstable linear ends into stable continuous structures, resolving the degradation issue while preserving synthesis ease

Inventive Principle:
Principle #13The other way round (Inversion)

2Productivity

If bacterial cell culture methods are used to generate circular nucleic acids, then large-scale production is achieved, but contamination risks and purification complexity increase

Engineering Contradiction:
Improvelarge-scale production capabilityVSAvoidpurification process complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention extracts the circularization step from the bacterial culture process entirely. By performing chemical or enzymatic circularization on synthesized linear DNA in vitro, it removes the source of contamination (bacterial cells) while maintaining production capability, thereby simplifying purification requirements

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces an intermediary circularization step using chemical reagents or enzymes as mediators between linear DNA synthesis and final circular product formation. This intermediary process enables large-scale production without bacterial contamination, reducing purification complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If rolling circle amplification is used to generate concatamers, then amplification efficiency is improved, but transformation efficiency decreases due to linear tandem repeat structures

Engineering Contradiction:
Improveamplification efficiencyVSAvoidtransformation efficiency
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The invention performs preliminary circularization of the concatamer structures before transformation. By circularizing the amplified DNA products in advance, the transformation-competent circular form is prepared beforehand, maintaining the high amplification efficiency of RCA while enabling efficient transformation

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Instead of attempting to transform linear concatamers directly, the invention inverts the approach by circularizing the concatamers first and then transforming. This reversal of the typical linear-to-circular conversion timing preserves amplification efficiency while achieving transformation competence

Inventive Principle:
Principle #13The other way round (Inversion)

4Reliability

If multiple enzymatic reactions are used to convert concatamers to circular nucleic acids, then circularization is achieved, but process time and cost increase

Engineering Contradiction:
Improvecircularization completenessVSAvoidconversion process time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention merges multiple enzymatic functions into a single reaction step or uses a single enzyme that performs both cleavage and circularization functions. This consolidation maintains complete circularization while significantly reducing process time and operational complexity

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention employs a universal enzyme or reagent system that can handle different concatamer structures and perform circularization in a single step. This multi-functional approach achieves complete circularization without requiring multiple specialized enzymatic reactions, reducing time and cost

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 produces high-quality circular nucleic acids with enhanced transformation efficiencies and simplified purification, reducing contamination risks and production costs, making them suitable for large-scale therapeutic applications like DNA vaccines and gene therapy.

Implementation Method 1

amplifying the circular nucleic acid template by rolling circle amplification to form a concatamer

Methodology Applied
Scientific EffectRolling circle amplification:

Implementation Method 2

incubating the tandem repeat nucleic acid sequence with a recombination protein to generate a circular nucleic acid

Methodology Applied
Scientific EffectSite-specific recombination:

Data Source

PatentEP4012027A1DNA mini-circles and uses thereof
Publication Date: 2022.06.15 GLOBAL LIFE SCI SOLUTIONS OPERATIONS UK LTD
  • EP4012027A1 patent drawingFigure 1
  • EP4012027A1 patent drawingFigure 2
  • EP4012027A1 patent drawingFigure 3

AI summary

Methods and kits for generating circular nucleic acids in a cell-free system, and uses for the generated circular nucleic acids are provided. The methods comprise in vitro amplification of a nucleic acid template comprising a recombination site to produce tandem repeat nucleic acid sequence, and employ a recombination protein to generate the circular nucleic acids from the tandem repeat nucleic acid sequence.