ONGOING QUALITY SUPPORT
Ongoing Peptide Quality Support
Recurring quality infrastructure for commercial and late-stage peptide programs. From reference material supply to routine analytical testing and stability monitoring.
Discuss Ongoing Quality SupportFOR
SERVICES
Recurring Quality Services
Recurring Reference Material Supply
Ongoing supply of parent and impurity reference materials. New lot preparation, characterisation and qualification.
New Lot Characterisation
Analytical characterisation and qualification of new reference material lots. Lot-to-lot comparison and documentation.
Routine Analytical Testing
Scheduled analytical testing of drug substance or reference materials. Purity, identity and impurity profiling.
Impurity Monitoring
Ongoing monitoring of known impurity profiles. Detection of new or emerging impurities. Trend analysis.
Stability Support
Scheduled stability study intervals. Analytical testing at defined time points. Stability data reporting.
Analytical Troubleshooting
Investigation of unexpected analytical results, method failures or new impurity observations.
Method Lifecycle Support
Method updates, revalidation support and analytical method transfer assistance.
DISCUSS ONGOING QUALITY SUPPORT
Discuss Ongoing Quality Support
Describe your peptide program and current quality support requirements. PeptiQore will propose an appropriate recurring support structure.
Discuss Ongoing Quality Support