Introduction to Technologies
for Continuous Manufacturing of Drug Products

Continuous manufacturing system does not require scale-up during development. It enables us to significantly reduce the use of valuable and expensive APIs because what you must do is only add APIs of the amount needed to obtain drug product you require. Scale-up studies are not necessary for commercial manufacturing. Therefore, the development period can be shortened, and study resources can be reduced.
The amount of the drug product can be freely changed in the commercial manufacturing to accommodate changing supply demand.
During both development stage and commercial manufacturing, processes are monitored in real time and continuously operated. Therefore, time loss is not expected, and period of development or commercial manufacturing are shortened. PAT (Process Analytical Technology) tools are used at each principal process to monitor CQA (Critical Quality Attribute) or CMA (Critical Material Attribute) to ensure high quality of the product.
In the continuous manufacturing system, smaller equipment is connected to each other. It has many advantages such us smaller equipment footprint, less operators, reduction of human errors and lower risk of contamination by foreign particles. On the other hand, it has some issues to be solved: new investment in equipment, establishment of high-level quality monitoring systems using PAT tools, and fewer NDA or ANDA applications in the past. Shionogi Pharma has introduced a continuous manufacturing system and will file NDA applications for products manufactured by this system as early as possible. Shionogi Pharma’s experiences in the continuous manufacturing will be used for customer support.

The picture below is CTS-MiGRA continuous manufacturing system developed by Powrex Corporation. Since Shionogi Pharma introduced this system, it can seamlessly manufacture both clinical trial drugs and commercial products, without site changes accompanied by many kinds of losses.

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