Process and product related impurity testing
Capabilities
The team at Drug Development Solutions has extensive method development experience using a wide range of state-of-the-art chromatography and mass spectrometry instrumentation. These instruments are used in the development and optimisation of analytical methodology for the analysis of process related impurities to support bioprocess validation, in line with ICH Q6B.
Techniques
- HPLC and UPLC with PDA, MS, UV
- GC and Headspace GC with FID, ECD, MS (Agilent 7890B GC with Agilent 5977 MSD)
- High resolution LC-MS
- Waters Acquity H-Class (PDA) with Waters Synapt G2 Q-TOF MS (with Ion Mobility Separation)
- Waters Acquity H-Class (PDA) with Waters Xevo G2 XS MS
- Supercritical fluid chromatography (SFC) with PDA, MS
- Inductively Coupled Plasma with Optical Emission Spectrometry (ICP-OES) - Thermo iCAP7600 Duo
- Inductively Coupled Plasma with Mass Spectrometry (ICP-MS) - Agilent 7700x and Agilent 7900
The optimised methods can then be validated either as a limit test or full ICH Q2 (R1) validation performed at our UK GMP Laboratories.
Applications
We can develop methods for the following types of potential impurities listed below, covering all stages of the manufacturing process:
- Antifoams
- Antibiotics
- Growth Promotors
- Redox Reagents
- Detergents
- Process Additives
- Extractables & Leachables
Host Cell Protein
We have the capability to assess host cell protein in both drug substance and drug product as a product related impurity to support bioprocess validation, in line with ICH Q6B.
Techniques
- Elisa based assays
- Perkin Elmer Envision Xcite Plate Reader
- Molecular Devices Spectramax ID5
