Alcami Corporation
2320 Scientific Park Dr.
Wilimington, NC 28405
T: (800) 575-4224
W: www.alcaminow.com

 

Partnering with Alcami as your contract development and manufacturing organization connects you to a US-based team of dedicated professionals with over 40 years of experience advancing products through every stage of the development lifecycle. Whether you are a virtual start-up or a large organization, you and your patients deserve subject matter experts who take ownership of your program from clinical trials through commercial supply. Alcami serves biologics and pharmaceutical companies of all sizes providing customizable and innovative solutions for development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, and analytical services.

Quality & Compliance

  • Experience supporting over 500 IND filings and over 30 NOA/ANDA approvals
  • In-house quality team and regulatory support
  • Successful regulatory inspection history
  • Controlled substance capabilities at all facilities

Analytical Services

  • Analytical development and validation for small and large molecules/biopharmaceuticals
  • Environmental monitoring and cleanroom services
  • Stability storage and testing
  • Routine/compendial chemistry and microbiology testing
  • Elemental impurities
  • Abuse-deterrent studies, pediatric food studies, and other specially services

Oral Solid Dose Manufacturing

  • Clinical formulation development and commercial dosage form design
  • Low shear, high shear, spray granulation, roller compaction, and direct compression
  • Powder in capsul/bottle, modified release, mini-tablets, sprinkle capsules, orally disintegrating, chewables, and other pediatric and specialty dosage forms
  • Flex suites for novel manufacturing processes

Parenteral Manufacturing

  • Formulation development of parenteral dosage forms and placebos
  • Manufacturing of sterile solutions, suspensions, and emulsions
  • Prefilled syringes and glass vials
  • Fill-finish of large molecules/biopharmaceuticals
  • Aseptic/sterile processing, terminal sterilization, and lyophilization