cGMP
Almac Sciences has built a cGMP manufacturing track record over more than a decade – with Quality Systems that are integral to our business. We apply this expertise to the compound labelling process, ensuring that your product is fit for your
ADME
studies and 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:
- IV dosage form
- Solid dosage form
State of the art facilities
- Access controlled
- Dedicated GMP areas
- Bunded worktops
- Extensive analytical capability within our Isotope Chemistry facility
- Validated quality critical equipment
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
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