COMPLETE QUALITY PACKAGE
Complete Peptide Quality Package
End-to-end peptide quality infrastructure for new peptide developers, generic peptide developers, biotech companies and academic translation projects.
REQUEST
Discuss a Quality Program
Submit a qualified scientific inquiry to discuss the scope, timeline and requirements for a complete peptide quality program.
Discuss a Quality ProgramPOTENTIAL SCOPE
What a Quality Package Can Include
Quality Risk Assessment
Systematic assessment of impurity risks, degradation pathways and analytical requirements for your peptide.
Impurity Profiling
Comprehensive identification and characterization of process-related, sequence-related and degradation impurities.
Reference Material Strategy
Development of a reference material strategy aligned with your analytical and regulatory requirements.
Analytical Characterization
High-resolution LC-MS and HPLC characterization of your peptide and related impurities.
Analytical Method Development
Development of fit-for-purpose HPLC and LC-MS methods for identity, purity and impurity analysis.
Forced Degradation
Systematic forced degradation studies to characterize degradation pathways and identify degradation products.
Stability Strategy
Stability-indicating method development and stability study design.
Method Validation Support
ICH Q2(R2)-aligned method validation for key analytical methods.
Quality Documentation
Structured quality documentation supporting regulatory submissions.