TriPharm


Alcami is a US-based contract development and manufacturing organization with over 45 years of experience in advancing pharmaceuticals and biologics from development to delivery. They provide integrated solutions including lab services, drug product manufacturing, and cGMP storage and support services, with a focus on quality, compliance, and innovation. Their mission is to deliver reliable solutions that unlock the potential of transformative medicines, acting as a trusted partner in the pharmaceutical and biotech industries.

Industries

health-care
pharmaceutical

Nr. of Employees

small (1-50)


Services

End-to-end sterile and oral solid dose development and manufacturing services from preclinical through commercial supply, including formulation, aseptic filling, lyophilization, packaging and labeling.

Analytical method development, method validation, routine QC testing, microbiology and specialized biologics/cell and gene therapy analytical services.

Validated cGMP storage for temperature-sensitive products with environmental monitoring, calibration/metrology, validation (CQV), secure access controls and redundant utilities.

Qualification and validation services for controlled chambers, sterilization processes, CTU requalification, thermal mapping, steam quality testing and related CQV deliverables.

ISO/IEC 17025–accredited calibration and metrology, primary standards maintenance and traceable calibrations for mass, temperature and pressure.

Validated regional courier services and transportation options for ambient, refrigerated and frozen shipments with DOT and IATA compliance.

Expertise Areas

  • Drug product manufacturing (sterile and oral solid dose)
  • Analytical method development and QC testing
  • cGMP pharmaceutical storage and stability programs
  • Commissioning, qualification and validation (CQV)
  • Show More (6)

Key Technologies

  • High-performance liquid chromatography (HPLC)
  • Mass spectrometry
  • Selected ion flow tube mass spectrometry (SIFT‑MS) / direct-injection MS
  • Headspace analysis
  • Show More (8)

News & Updates

Alcami announced the appointment of Tori E. Arens as President, Drug Product, on February 12, 2024.


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