“No Clinically Meaningful Differences”: How FDA Defines the Standard for Biosimilar Approval
Introduction Under Section 351(k) of the Public Health Service (PHS) Act, the U.S. Food and Drug Administration (FDA) defines a […]
FDA Withdraws Its 2015 Biosimilarity Guidance: What Replaces It and What Changes for Developers
Introduction On March 9, 2026, the U.S. Food and Drug Administration (FDA) officially announced the withdrawal of its 2015 biosimilarity
Oligonucleotide Drug Development at a CDMO: Analytical Characterization and Impurity Challenges
Introduction: Oligonucleotide CDMO Services give drug developers a single, analytically grounded route from sequence design to GMP drug substance, and
Statistical Approaches to Analytical Similarity: Quality Ranges, Equivalence Testing and How FDA Judges the Data
Introduction Statistical Approaches to Analytical Similarity encompass quantitative, risk-based frameworks used by regulatory authorities and biopharmaceutical developers to establish that
Residual Uncertainty in Biosimilar Development: How the Stepwise Approach Decides What Studies You Need Next
Introduction Residual uncertainty in biosimilar development determines the scope of regulatory clinical trials by requiring each successive stage of testing
Case Study: Improving Conjugation Yield in a Complex Peptide-Oligonucleotide Program
Introduction: Peptide-Oligonucleotide Conjugation Yield Optimization is the systematic improvement of the reaction and recovery processes used to make a peptide-linked
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Data Integrity at CDMOs: ALCOA+ Principles and 21 CFR Part 11 Expectations
Introduction: Data Integrity at CDMOs: ALCOA+ and 21 CFR Part 11 is the foundation of trustworthy outsourced development and manufacturing,
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ICH Q3D Elemental Impurities Risk Assessment: How a CDMO Builds the Control Strategy
Introduction: ICH Q3D elemental impurities risk assessment is a critical part of pharmaceutical quality management, because metals can enter drug
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Case Study: Immunogenicity Risk Assessment of a New Impurity in a Generic Peptide ANDA
Introduction: Immunogenicity Risk Assessment of Peptide Impurities is a key part of pharmaceutical development whenever an unexpected impurity appears in
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Is Peptide Synthesis the Same as Protein Manufacturing?
Introduction: Peptide Synthesis vs Protein Manufacturing is an important distinction in pharmaceutical development, biotechnology, and analytical science, and the two
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