Trans-pseudotyping Recombinant AAV Production

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current methods for producing adeno-associated virus (AAV) particles require the continuous provision of AAV genome in trans, which is inefficient and limits the production of AAVs that do not efficiently infect production cell lines such as HEK293 cells.

Innovation Solution

The process of trans-pseudotyping, where first recombinant AAV particles are produced in first host cells with a tropism towards production cell lines, and then second recombinant AAV particles are produced in second host cells with a different tropism towards therapeutic target tissues, using co-infection with adenovirus expressing rep and cap genes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If AAV particles with specific capsid tropism are used to infect target cells, then therapeutic specificity is improved, but production efficiency in standard cell lines deteriorates

Engineering Contradiction:
Improvetherapeutic specificityVSAvoidproduction efficiency
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The production process is divided into two distinct stages: first, production of AAV particles with production-efficient capsid (e.g., AAV2) in standard HEK293 cells to generate high viral titers; second, use of these particles to infect target cells where a different capsid (e.g., AAV9) is provided in trans to achieve therapeutic specificity. This segmentation allows optimization of production and therapeutic function separately.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

AAV particles produced with one capsid type serve as an intermediary vehicle to deliver the genome to target cells, where the capsid type is then replaced through co-infection or transduction with particles expressing the desired therapeutic capsid. This intermediary approach enables decoupling of production efficiency from therapeutic specificity.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If AAV genome is provided in trans continuously, then production flexibility is improved, but production efficiency deteriorates

Engineering Contradiction:
Improveproduction flexibilityVSAvoidproduction efficiency
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The AAV genome is provided in trans before the production step, allowing the production cell line to be pre-prepared with all necessary viral components except the capsid. This preliminary setup enables efficient production without the need for continuous provision of the genome during the production process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The production system is designed to use the provided AAV genome and helper functions to autonomously produce viral particles with the desired capsid type, eliminating the need for continuous external provision of the genome and reducing production bottlenecks.

Inventive Principle:
Principle #25Self-service

3Object-affected harmful factors

If rep and cap genes are removed from AAV genome, then vector safety is improved, but production complexity deteriorates

Engineering Contradiction:
Improvevector safetyVSAvoidproduction complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The rep and cap genes are extracted from the AAV genome to create a replication-defective, non-integrating vector that is safer for therapeutic use. The extracted cap gene is then provided separately in trans during production, allowing the genome to remain simple and safe while production complexity is managed through the separate provision of necessary components.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The AAV genome is designed to be universal and replication-defective, relying on helper functions provided in trans for production. This multi-functional design allows the same genome to be used for different capsid types and production methods, simplifying the vector design while managing production complexity through standardized helper systems.

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

Data Source

PatentEP4200428B1Method of making recombinant aavs
Publication Date: 2025.02.19 OXFORD GENETICS
  • EP4200428B1 patent drawingFigure 1
  • EP4200428B1 patent drawingFigure 2

AI summary

The present invention relates to a process for producing recombinant adeno-associated virus (AAV) particles, described herein as trans-pseudotyping. The process involves the production of recombinant AAV particles in first host cells and then in second host cells, wherein first and second AAV cap genes are expressed in the first and second host cells, respectively, thus producing first and second recombinant AAV particles which are encapsidated by first and second AAV capsid polypeptides. The first and second recombinant AAV particles have different cell tropisms, preferably towards production cell lines (for high efficiency production of AAVs) and for cells associated with a therapeutic indication (for treatment of such an indication), respectively.