How ICP-MS Supports Elemental Impurity and Extractables and Leachables E&L Investigations
Introduction: Why ICP-MS Is Essential in E&L Investigations Whenever a drug product comes into contact with a container-closure system, manufacturing […]
How to Prove PLGA Polymer Sameness for ANDA Submission: Analytical Strategy and Regulatory Expectations
Introduction: For manufacturers pursuing approval of a generic PLGA-based injectable depot product, demonstrating PLGA polymer sameness for an ANDA submission
Nitrosamine Impurities in Biologics and Biotechnology-Derived Products: Regulatory Status and Testing Approach
Introduction: The Expanding Regulatory Landscape for Nitrosamine Impurities in Biologics The nitrosamine crisis that affected the small-molecule pharmaceutical industry between
Stability Studies and Leachables Monitoring: What Sponsors Should Know
Introduction: Why Leachables Monitoring Must Be Central to Your Stability Program Many sponsors still approach stability studies primarily as a
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Buprenorphine Depot PLGA Characterization: High Drug Load Challenges in Long-Acting Injectables
Summary: 1: Introduction: Buprenorphine PLGA Depot Characterization is critical for the development of long-acting injectable formulations intended for opioid dependence
Characterization of Long-Acting Biologics in PLGA Systems
Introduction: Why Characterization of Long-Acting Biologics in PLGA Demands a Dedicated Framework The characterization of long-acting biologics encapsulated within poly(lactic-co-glycolic
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Circular Dichroism (CD) Spectroscopy for Peptide Secondary Structure Characterization
Introduction: Why CD Spectroscopy Continues to Be the Gold Standard for Peptide Secondary Structure Characterization When evaluating the secondary structure
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Glycopeptide Characterization: Analytical Approaches for Glycosylated Therapeutic Peptides
Introduction: Glycopeptide Characterization is a critical analytical process used to identify, quantify, and structurally analyze glycosylated therapeutic peptides. Glycosylation is
How Glass Transition Temperature (Tg) of PLGA Affects Drug Release and Formulation Stability
Introduction The Glass Transition Temperature (Tg) of PLGA is far more than a routine material specification. It functions as the
Disulfide Bond Mapping in Therapeutic Peptides: LC-MS Strategies and Analytical Challenges
Introduction: Disulfide Bond Mapping in Therapeutic Peptides is a critical analytical process used to verify the structural integrity and biological