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.  

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.