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. Our facility 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 has your development needs covered, 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 is predicated on the seamless integration of all our operations and that includes packaging and distribution, an area made all the more critical with the advent of supply chain security initiatives by regulators. With packaging and distribution on site, seamless integration with manufacturing operations is assured. We provide custom packaging, labeling and kitting for materials destined for trials and markets anywhere in the world.
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.