The Alcami Advantage

Analytical development and validation for small-molecule, biotechnology, and large molecules

Physical chemistry and material characterization

Stability storage and analysis

Compendial raw materials testing.

More than 300 compounds formulated over 30-plus years

Oral solid dose development

Parenteral (both liquid and lyophilized) formulation development

Oral drug delivery technologies

Kilograms to multitons CGMP production

Up to 2,000-gallon scale

State-of-the-art isolation and containment equipment

Scalability across all sites driven by robust process development, design of equipment system modeling, engineered solutions, and technology alignment

CGMP kilo laboratory up to 2,000-gallon reactor suites

Expert level request for qualification (RFQ) assessment.

Batch sizes ranging from 200 g of active pharmaceutical ingredient (API) for phase 1 powder in capsules on the Xcelodose to large-scale commercial tablet batches up to 650 kg

Potent compound manufacturing

Dry blends, roller compaction, wet granulation (low/high shear and spray), film coating, and tablet and capsule manufacturing

Flex suites for novel manufacturing processes.

Sterile products for small molecules and biotechnology, including proteins, peptides, monoclonal antibodies, and other large molecules

Batch sizes from 220 mL to 340 L

Aseptic filtration/filling, terminal sterilization, and lyophilization.

Custom packaging, labeling, and kitting for clinical trial supplies

Special packaging needs — square bottles, blisters, cartons, vials, ancillary supplies, concomitant medications, cases, and cachets

Temperature- and humidity-controlled storage

Temperature monitoring and validated shipment configurations.

Quality assurance

Regulatory affairs

Stability management.