cGMP

cGMP

Almac has built a significant cGMP manufacturing track record, with Quality Systems that are integral to our business. We routinely apply this expertise to ensure that your product is suitable for clinical use.

Radiolabelled Drug Product Manufacture & QP Release

Aligned with our supply chain solutions, we provide formulated and labelled drug product which can be released by Almac’s on-site QPs and shipped directly to your clinical trial facility.
We provide:

  • Solid dosage form
  • IV dosage form

State of the Art Facilities

  • Access controlled
  • Dedicated GMP areas
  • QA input into facility design
  • MHRA approved
  • Extensive analytical capability within our Isotope Chemistry facility

Validated Quality Critical Equipment

  • Tri-Carb 2900 scintillation analyser
  • 3, 5, and 6 point analytical balances
  • Agilent HPLC with radioflow, UV, fluorescence detection
  • Agilent semi-prep HPLC
  • 2-8°C, -20°C and -80°C fridges and freezers
  • Buchi rotavapors
  • Mini series beta and brehmstrahlung detectors
  • FlashMaster chromatography system
  • Hot plate stirrers
  • Hanna pH meter
  • Vacuum manifold
  • Vacuum oven
  • NMR / MS / LC-MS / GC

Download our library of expertise including case studies, presentations and publications

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