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Advances in genetics and bioengineering have enabled the development of gene therapy and with it, the unprecedented potential to treat diseases caused by recessive gene disorders, acquired genetic diseases, and some viral infections. Technologies for manufacturing and analysis of gene therapy products are evolving with continued efforts to be fully optimized.
Solutions from Thermo Fisher Scientific are evolving as well. Our robust assays are tailored for the analysis of gene therapy products to enable fast results with better accuracy and reproducibility to facilitate the development of your gene therapy product and accelerate its progression to market. There are several recombinant DNA technology protocols, in which the gene-of-interest or healthy gene is inserted into a vector, which can be a viral, plasmodial, or nanostructured.
Messenger RNAs (mRNA) therapies — which upon introduction to the target cell are translated into desired proteins — are being explored in the use of personalized immunotherapy.
A cutting edge collaboration for oligonucleotide analysis and mRNA characterization
Popular products for gene therapy analysis
Adeno-associated virus (AAV) vector gene therapy workflows
AAV production & purification
Premier Thermo Fisher Scientific brands for AAV gene production & characterization workflows
These brands are ideal for developing end-to-end workflows for AAV gene therapy production and characterization.
AAV vector development and production workflow
There are multiple strategies to develop AAV vectors, but typical steps include plasmid development and production, cell expansion, plasmid transfection, viral vector production, purification, and fill and finish. Transient expression of AAV in either adherent or suspension cell lines are most common in pre-clinical and early phase development. An alternative option for AAV production is the development of a stable producer cell line which helps ensure long-term stable supply of the viral vector.
For details, go to: AAV Production Workflows
Innovative chromatography solutions, specifically designed to improve the downstream purification of mRNA and viral vectors such as the Adeno-Associated Virus (AAV), lentivirus, and Adv5.
For details, go to: Cell and Gene Therapy Purification Solutions
AAV gene product and process characterization and quality control
FDA guidance for industry on characterisation requirements for gene therapy products, focus on structure and characteristics of the product, process related impurities, and product related impurities. Below are the optimized workflows utilizing leading Thermo Scientific instruments, consumables, and software for AAV product and process characterization