Chemical process development of an active pharmaceutical ingredient (API) or drug substance and the pharmaceutical development of the final, formulated drug product from this API are frequently treated as independent activities in the overall process of developing a new drug.
Continuous manufacturing enables the development of a more diverse pipeline of drug products by greater quality assurance, reduced API usage, and timeline efficiencies. It also reduces scale-up activities as a product increases in volume in the clinical phase through commercial. With that comes the benefits of reduced API usage, and therefore costs. Additional benefits include timeline efficiencies as well as a reduction of technical risks, as continuous manufacturing systems are designed with integrated solutions that allow for real-time analysis and control. The key quality driver with continuous manufacturing is that you understand what the process is doing on a second-by-second basis and judge your material as it is produced rather than in its entirety at the end. Improving quality oversight and thereby reducing rejections also lessens handling and timelines in manufacturing, which helps lower the total cost of ownership. Continuous manufacturing is one node in a more flexible supply chain where production quantities can be flexed based on demand while still maintaining the same assurance of product quality.
As a result of these benefits, we have seen an increase in FDA approvals of oral solid dose drugs produced using continuous manufacturing as well as investments in technology within the pharma industry. Nevertheless, the pace of its adoption still lags when compared to the growing demand for new drug products and the drive to reduce total cost of supply. This delay is not uncommon in an industry averse to change; however, it could also be related to a lack of understanding about the application of continuous manufacturing in both development and commercial manufacturing and/or education about its implementation. Therefore, by gaining a better understanding of continuous manufacturing and its fitness for your oral solid dose product, you could potentially secure more control over the quality and safety of your product and, ultimately, the future of its success.