Alcami Capacity Update October 2024: Small Molecule

Alcami, a U.S.-based contract development and manufacturing organization headquartered in North Carolina, brings over 45 years of experience advancing pharmaceuticals and biologics from development through delivery. Our capabilities include comprehensive oral solid dose (OSD) development, solid-state characterization, clinical manufacturing, batch scale-up, and commercial manufacturing. Our OSD facility supports DEA Schedule I-V materials, Safebridge 3b compounds, and operates low-humidity suites qualified to less than 30% RH. Additionally, we offer a cutting-edge OSD development suite equipped with small-scale versions of our commercial manufacturing equipment, a non-GMP analytical testing lab, stability chambers, and blistering equipment, all designed to expedite product development. The facility supports commercial blends up to 650 kg.

We also provide extensive packaging services, including bottling, blistering, vial labeling, and pre-filled syringe labeling with plunger rod insertion. Alcami’s packaging solutions ensure full serialization and aggregation from the sellable unit through palletization. Our secondary packaging capabilities are wide-ranging, offering carding, walleting, cartoning, and kit assembly. With specialized expertise in clinical labeling, Alcami can manage open, blinded, and double-blinded clinical materials to meet diverse study requirements.