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Raw Material Testing
The Raw Material Testing Center of Excellence (CoE) was established to support the global expansion of WuXi Biologics. Since its inception, the CoE has developed and established world-class and comprehensive raw material testing capabilities (USP, EP, JP, & ChP, etc.) that provide complex, centralized raw material release testing and technical support to our various sites. Not only has the Raw Material Testing CoE continually improved and aligned our raw material testing strategies and procedures, it has also provided critical and timely release testing. These capabilities successfully support our client’s projects from pre-clinical development through to commercial production .
- The CoE has continually developed and implemented new technologies including:
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- Agilent Portable RapID Raman Spectrometer for fast raw material (unopenedcontainer ) identification in the warehouse
- GC/MS analysis for impurities in raw materials
- Halogen Moisture Analyzer for fast moisture determination in raw materials
- LC/MS (QDA) analysis of amino acids for media identification
- The CoE is well equipped with the state-of-the-art analytical technologies including:
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- Spectroscopy (FT-IR, NIR, UV/Vis, and Raman)
- Chromatography (HPLC/GC with multiple detectors and pre/post-column amino acid derivatization HPLC methods)
- Titration (Automatic, Potentiometric, and Karl Fischer) and other common compendial instruments (Melting Point, LOD/ROI, Optical Rotation, Refractivity, Viscosity, etc.)