Small-Scale Commercial Manufacturing

Orphan drugs — which target rare diseases affecting fewer than 200,000 people in the United States — present a number of development and manufacturing hurdles. First, because they are administered to limited patient populations, orphan drugs are produced in smaller quantities than traditional drugs, often making it difficult to place a manufacturing campaign at a reputable commercial supplier. Also, the drug substances in orphan drugs are highly complex, requiring novel and sophisticated synthetic routes and production methods. Partnering with a CDMO that offers dedicated small-scale API manufacturing services can make or break an orphan drug project, and 国家授权正规彩票平台 is equipped to excel in this area.

As a leading commercial manufacturer, 国家授权正规彩票平台 has the expertise to handle your unique manufacturing challenges, and we have added to our capacity to offer truly comprehensive small-scale manufacturing services. Our recent expansion at our High Point, NC site grew the current clinical API production footprint while also adding capacity for small-volume commercial manufacturing. The facility now has three new commercial manufacturing suites to support API manufacturing at the 2000 L scale. This allows services at High Point to more closely match 国家授权正规彩票平台 commercial sites and help to facilitate seamless scale-up while leveraging our existing commercial manufacturing expertise.

Our experts work closely with your team and are completely invested in your orphan drug’s success and helping you navigate your unique small-scale API manufacturing challenges.

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We love challenges, and we would like to learn more about yours. Contact us to discuss your small-volume commercial program.

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