Manufacturing your drug product is at the heart of Alcami’s commitment to scalable, cGMP compliant, and inspection-ready supply chain solutions. Our biologics drug product capabilities fit seamlessly into Alcami’s parenteral manufacturing facility to support your preclinical through commercial scale supply. This US- and EU-compliant and DEA-licensed sterile site is fully integrated with our biologics analytical development and testing laboratories.
Alcami is well versed in the technical evaluation, formulations development, and technology transfer process. We offer best-in-class expertise for liquid-in-vial and lyophilized formulation development.
- Asceptic/sterile drug product manufacturing and fill/finish of mAbs, peptides, and protein based therapeutics
- Clinical to commercial scale batch sizes in 2 mL to 50 mL vials
- Formulation development
- Non-standard dosage forms such as suspensions, emulsions, etc
- Lyophilization cycle development
- In-house extractables & leachables evaluations