ABOUT US Partnering with Alcami connects you to a team of highly-intelligent problem solvers that can advance your product through every stage of the development lifecycle. With over 300,000ft² in the US, our team of 700 professionals across four US scientific campuses serves biologics and pharmaceutical companies of all sizes.
Leveraging over 40 years of experience, Alcami provides customizable and innovative solutions for formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services. Whether you are a virtual start-up or a large organization, we can help you deliver breakthrough therapies to patients faster.
ANALYTICAL SERVICES Our network of cGMP centers offers comprehensive testing services for new drug entities, generic drugs, animal health products, over the counter medications, chemicals, and biopharmaceuticals.
• Analytical development and validation for small and large molecules/biopharmaceuticals
• Environmental monitoring and cleanroom services
• Routine compendial chemistry
• Microbiology testing including rapid sterility and microbial in-use studies
• ICP-MS capabilities including elemental impurities, catalyst control, organometallics, and assays
• Abuse-deterrent studies, pediatric food studies, and additional specialty services
• Stability storage and testing
ORAL SOLID DOSE MANUFACTURING Alcami can formulate and engineer robust, scalable manufacturing processes to supply your clinical and commercial oral solid dose manufacturing needs.
• Clinical formulation development and commercial dosage form design
• Low shear, high shear, spray granulation, roller compaction, and direct compression
• Powder in capsule/bottle, modified release, minitabs, sprinkle capsules, orally disintegrating, chewable, and other pediatric and specialty dosage forms
PARENTERAL MANUFACTURING We provide customizable formulation development and sterile fill-finish manufacturing support for small and large molecules from preclinical product development through commercial launch and supply.
• Liquid and lyophilized
• Pre-filled syringes/vials
• Solutions, suspension, emulsions
• Formulation development of parenteral dosage forms and placebos
PACKAGING & LABELING Custom packaging services available from stand-alone projects through full development programs.
• Primary Packaging
• Secondary Packaging
• Storage & Distribution
New brand and identity provides an integrated offering for both drug substance and drug product