Views: 0 Author: Site Editor Publish Time: 2023-03-10 Origin: Site
With the rapid development of life sciences, an increasing number of diseases caused by defective genes have been discovered. In recent years, numerous innovative gene therapy technologies and clinical trials have emerged, making gene therapy a new treatment option. Consequently, it is profoundly reshaping the landscape of the healthcare industry.
As an emerging medical field, gene therapy remains relatively obscure. Despite its promising prospects, the road to its development is inevitably fraught with obstacles due to the immaturity of related technologies. Until the early 21st century, technological breakthroughs have significantly enhanced efficacy and safety of the gene therapy by overcoming certain technical limitations. These advancements have propelled the gene therapy industry into a period of rapid development.
Figure 1 Development History of Gene Therapy
How is “gene therapy” defined? The concept of gene therapy was first proposed in the 1970s, involving the replacement and repair of individual pathogenic genes. With advancements in technology, the scientific community has gradually expanded the initial definition of gene therapy. Now, gene therapy refers to the introduction of normal genes into human cells to correct or compensate for genetic defects or abnormalities that cause diseases. It is a fundamental therapeutic strategy that differs fundamentally from conventional treatment methods.
Gene therapy | Conventional therapy | |
Object | DNA | Protein |
Efficacy | To repair defective genes and cure diseases fundamentally | To address phenotypic variations. Certain diseases cannot be cured by modulating proteins. |
Safety | There are still some cognitive blind spots regarding this emerging therapeutic technology. Gene alterations cannot be reversed, hence the use of gene therapy entails certain risks. | Conventional treatment has undergone a long period of development, and its system is relatively mature, with most side effects being relatively controllable. |
Table 1 Gene Therapy Vs Conventional Therapy
Gene therapy includes two basic approaches: in vivo and ex vivo methods.
Figure 2 Process for Gene Therapy
Figure 3 Introduction of Normal Genes into Target Cells by Recombinant Virus
The process for “in vivo” gene therapy is simple, including 3 steps:
Figure 4 Process for “In Vivo” Gene Therapy
The process for “ex vivo” gene therapy is complicated, including 6 steps:
Figure 5 Process for “Ex Vivo” Gene Therapy
Viral vector preparation is indispensable and important in the gene therapy stage, and HEK293 cells are the most commonly used host cells for viral vector packaging and production. Our independently developed EmCD HEK293 Plus media are exclusively designed for human embryonic kidney (HEK293) cells. It supports high-density suspension culture and transient transfection of cells, and can be applied to the production of high-titer adenovirus, adeno-associated virus and lentivirus.
1. Splendid Performance
Compared with commercial media, our EmCD HEK293 Plus media have incomparable advantages in terms of cell growth and transient expression of antibodies. With good cell growth status and stable amplification time, it can meet various needs from customers.
Figure 6 Status of Expi293F Cells Continuously Passaged in EmCD HEK293 Plus Media
Figure 7 Growth and Yield of Expi293F Cells When Transiently Expressed Using EmCD HEK293 Plus Media
2. Reliable stability
Different batches of EmCD HEK293 Plus media are basically consistent in cell growth and yield, ensuring a stable supply of products.
Figure 8 Growth and Yield of Expi293F Cells When Transiently Expressed Using Different Batches of Culture Media
3. More Advantageous Quality System:
● Full animal-free lifecycle supply chain
Selected raw materials and contact materials with a 'Animal-free Statement'
Animal-free control throughout the factory
Animal-free Statement provided for each batch of finished products
● Quality commitment
Culture media are manufactured in compliance with the current GMP, ISO 9001 and ISO 13485.
● Controlled manufacturing environment
Dry powder products are manufactured in a Class D clean environment with special controls on humidity, temperature, differential pressure and airborne particles to prevent contamination, cross-contamination and confusion.
● Diversified manufacturing processes
Needle grinding manufacturing process
Hammer grinding manufacturing process
Multiple batches of EmCD HEK293 Plus media have been manufactured; the batch culture and transient expression have shown that different batches of media are basically consistent in cell growth and yield, and FDA DMF filing has completed, ensuring the safety and consistency of the manufactured recombinant protein or virus particles. In the future, Eminence's high-performance HEK293 Plus media are expected to be widely used in more biopharmaceutical companies.
References:
1 Gene therapy:progress and predictions.2015.
2 Gene therapy in glaucoma-3:Therapeutic approaches.2010