Process Residuals Analysis
Highly specific and sensitive techniques for process residual quantification in line with the requirements of ICH Q6B Guidelines.
The ICH Q6B Guidelines state that levels of process related impurities from protein bioprocessing should be determined and acceptance criteria established. These residuals are typically present in trace levels in sample matrices which can be challenging.
Highly specific and sensitive techniques are required for robust quantification to address these challenging method development and validation projects. Intertek apply a range of in-house analytical techniques and instrumentation including GC-MS, HPLC with UV detection, LC-MS or LC-MS/MS, NMR, ICP-MS and UV assay.
Intertek's Process residual analysis services include:
- Kanamycin
- Tobramycin
- Gentamycin
- Amoxicillin
- Chloramphenicol
- Glutathione
- Dithiothreitol (DTT)
- IPTG
- Triton-X
- Antifoaming agents
- Tween / Polysorbate
- DCA
- TCEP
- Heavy Metals
Protein Analysis Services
Request more information to see how Intertek can help your organization with Process Residuals Analysis.