The team at LGC 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 optimization of analytical methodology for the analysis of process-related impurities to support bioprocess validation, in line with ICH Q6B.
The optimized methods can then be validated either as a limit test or full ICH Q2 (R1) validation performed at LGC’s GMP Laboratories.
LGC can develop methods for the following types of potential impurities listed below, covering all stages of the manufacturing process:
Host Cell Protein
LGC has 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.
Elisa based assays: