The increasing trend of using highly potent active pharmaceutical ingredients (HPAPIs) in new drug development candidates has created a tremendous demand for high containment development and production capabilities.

Alcami is a trusted partner for the development and manufacture of HPAPIs. Our Germantown Center of Excellence for API development, scale up, and commercialization provides an exceptional platform for control strategy at each phase of the development process through a series of investments targeted at infrastructure, workforce, tools, and technology. Alcami’s extensive regulatory expertise allows innovators to execute all parts of development and manufacturing in one US‐based location to support the launch of tomorrow’s medicines.

Alcami will support your companion animal health products with precise attention to quality by design and process development. We have experience advancing over 50 animal health products from concept through commercialization, with services ranging from analytical support to manufacturing of active pharmaceutical ingredients (APIs), oral solid dose (OSD) products, and sterile (liquid and lyophilized) products. 

Over the years, the US Pharmacopeia (USP), International Harmonisation (ICH), Product Quality Research Institute (PQRI), and several other industry consortia have developed guidelines and best practices for these extractables & leachables studies.

Alcami has specialized knowledge of the most common materials of construction such as platinum-cured silicon, halobutyl rubber, cyclic olefins, polyethylene terephthalate (PET), polyvinyl chloride (PVC), and other elastomers. Vial and stopper configurations, spray pumps, and intravenous (IV) bags are among the most common packaging system components we evaluate. We welcome all routes of administration, including the more challenging prefilled syringes, blow-fill sealed vials, and laminated cans.

Specialized to manufacture oral solid dose (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. Our cGMP manufacturing technologies are arranged in flexible suites to support novel, advanced, and complex projects. 

In addition to OSD development and manufacturing, Alcami’s in-house analytical, stability, and packaging services provide an integrated and custom-tailored offering to help your product reach patients sooner.

Alcami's Charleston, South Carolina site is featured in a video produced by the Charleston Regional Development Alliance. Be sure to check out the video to see our facility, meet our team, and learn more about the growth in the Charleston area, and the role that Alcami plays.