What are the major technical obstacles to develop gene and cell therapy?

The main obstacles in the development of gene and therapy are manufacturing, affordability, and regulatory issues. 

Manufacturing

It can be very challenging to grow, source, and transport the cells. For this reason, many companies are developing solutions to overcome this problem and scale-up production. For example, TreeFrog Therapeutics has created an alginate encapsulation system to culture and transport stem cells in the ideal environment for their growth.

Affordability

Cell therapy, especially CAR-T cell therapy, can be expensive. The price of Kymriah in The USA is $475,000. This is due to the complex manufacturing process. Improving logistics would reduce the manufacturing cost and help to bring down the final cost of these drugs. When gene-editing is involved,

there is always a concern with the off-target effects and their consequences. 

Regulatory agencies are also trying to understand how to standardize different sections of the development process, such as manufacturing, as well as the supply chain to ensure proper quality control. 

References

https://www.labiotech.eu/in-depth/cell-therapy-obstacles-widespread-use/