Supporting Phase I to Phase III clinical production through commercial launch and supply
Specialized to manufacture oral solid dose forms, Alcami’s Wilmington, North Carolina site supports Phase I to Phase III clinical production through commercial launch and supply. Alcami is licensed by the US DEA to manufacture Schedule II-V substances along with highly potent compounds. Our cGMP manufacturing technologies, including low/high shear granulation and spray/fluid bed drying capabilities, are arranged in flexible suites to support advanced and complex solid oral dose products. Embedded within the manufacturing facility, our formulation development experts assist in product development and life cycle management including formulation changes and qualification of additional indications. Alcami’s scientists have experience in developing formulations, as well as designing and executing in vitro studies to fully characterize abuse-deterrent products. Alcami is equipped to support an expanding array of delivery methods, including immediate and extended-release tablets and capsules.
Hard shell capsules
- Powder blends
- Neat filled drug in capsule
- Beads or minitabs in capsules
- Over-encapsulation for clinical blinding
- Immediate release
- Sustained release
- Controlled release
- Orally disintegrating
Powders for reconstitution
Alcami’s overall operational excellence allows for a seamless integration of all our operations including packaging and distribution, an area made all the more critical with the advent of supply chain security initiatives by regulators. We provide custom packaging, labeling, and kitting for materials destined for global trials and markets.
Clinical phase supply is a particular area of focus. Alcami can provide specialized support including manufacturing and packaging of randomized and blinded supplies, as well as placebo, comparator, and crossover study supplies. We also provide reconciliation drug accountability and destruction services as needed.
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