QUALITY DEVELOPMENT PROGRAM
Peptide Quality Development Program
One integrated program connecting impurity strategy, reference materials, analytical development and quality control.
Not every module is required for every program. PeptiQore scopes based on development stage and project requirements.
FILTER BY DEVELOPMENT STAGE
Quality Risk Assessment
Systematic identification of potential quality risks for the peptide sequence — oxidation, deamidation, sequence impurities, degradation pathways and analytical complexity.
Impurity Strategy
Identification, classification and regulatory alignment of process-related and degradation impurities. Reference material planning.
Reference Material Strategy
Assessment of reference material requirements. Custom synthesis and characterisation planning for parent peptide and impurity standards.
Analytical Characterisation
Identity confirmation, purity assessment and initial impurity profiling. LC-MS characterisation where required.
Method Development
Analytical method development for purity, identity and impurity profiling. Forced degradation study design.
Forced Degradation
Forced degradation studies to identify degradation pathways and support stability-indicating method development.
Stability
Stability study design, analytical testing at defined intervals and stability data reporting.
Method Validation
Analytical method validation to ICH Q2(R2) or applicable regulatory guidance. Validation report preparation.
Routine Quality Support
Ongoing analytical testing, reference material supply, impurity monitoring and method lifecycle support for commercial programs.
Showing 6 of 9 modules typically relevant for Preclinical. Final scope is determined by project requirements.
DISCUSS A QUALITY DEVELOPMENT PROGRAM
Discuss a Quality Development Program
Describe your peptide program and development stage. PeptiQore will propose an appropriate program scope.