Advantages of CM

Orphan drug application is actually perfectly suitable for PCM processes as you can find today small-scale equipment and with this you can basically develop, manufacture clinical supply as well as first commercial supply with one and the same equipment. This will safe not only time for typical TT but even more importantly expensive API. Typically, CM systems have a much smaller product touching surface area and processing on a 6-Sigma level. This concludes in a better process yield and safe again expensive API. With the support of digital twins process optimization can take place at the same time when products are developed. This is another time saving factor. As continuous processes by reality are closed and highly integrated systems, you have less risk in regards of containment failure and therefore much higher operator safety which is very important for handling this class of APIs. In a summary: Many benefits for the orphan drug application.  

Also, if you are tight on space, or starting a greenfield project it can offer efficiencies there.

Plus, the flexibility inherent in CM processes (scale up or scale down) has the potential to effectively address the fluctuating market demands for such small scale products.

With regards to high value, low volume products there tends to be a desire to carry out small batches to limit processing risks in batch plant. Even at minimum stir volumes, the value of some products can reach millions in commercial batch plant. The use of CM effective eliminates this significant processing risk - you don't need to put effectively put all of your eggs in a single basket.