HPLC Qualification
Protocol employing orthogonal separation techniques
• An HPLC qualification protocol can be initiated as a stand-alone service, or as part of a cGMP development project
• HPLC isn’t just a tool – it’s a principle that defines chemistry at Macrocyclics
• Qualification includes verification of detector response, retention time consistency, injection precision, and method robustness
• Results provide assurance that the purity method is fit for purpose and can justify innovative CMC strategies to regulators
Impurity Identification
Synthesis analysis and structure elucidation
• Drug Substances advancing to late-stage clinical development require stricter controls on product impurities
• Macrocyclics uses NMR, HRMS, HPLC, and orthogonal spectroscopic tools to characterize impurities.
• Structural elucidation provides actionable guidance for process optimization and impurity reduction
Chelate Antibody Ratio
Platform test using High Resolution Mass Spectrometry
• CAR values influence target binding, stability, aggregation, and biodistribution
• HRMS analysis provides an empirical way to confirm chelator conjugation without requiring radioactivity
• Macrocyclics performs CAR analysis as a standalone service or alongside residual chelate analysis and SEC-UV protein concentration
Stability Programs
Assessments of temperature and formulation
• Accelerated and long-term stability studies evaluate how materials maintain integrity under various storage conditions
• Testing can include HPLC purity, chelate integrity, appearance, pH, and moisture analysis
• Stability data helps determine shelf-life, packaging requirements, and suitability for downstream applications
• Customized protocols available for early research materials through GMP-bound intermediates