Introduction Under the FDA’s Draft Guidance on Comparative Efficacy Studies, prospective biosimilar applicants may be able to avoid routine Phase […]
Introduction Under Section 351(k) of the Public Health Service (PHS) Act, the U.S. Food and Drug Administration (FDA) defines a
Introduction On March 9, 2026, the U.S. Food and Drug Administration (FDA) officially announced the withdrawal of its 2015 biosimilarity
Introduction: Oligonucleotide CDMO Services give drug developers a single, analytically grounded route from sequence design to GMP drug substance, and
Introduction Statistical Approaches to Analytical Similarity encompass quantitative, risk-based frameworks used by regulatory authorities and biopharmaceutical developers to establish that
Introduction Residual uncertainty in biosimilar development determines the scope of regulatory clinical trials by requiring each successive stage of testing
Introduction: Peptide-Oligonucleotide Conjugation Yield Optimization is the systematic improvement of the reaction and recovery processes used to make a peptide-linked
Case Study: Improving Conjugation Yield in a Complex Peptide-Oligonucleotide Program Read More »
Introduction: Data Integrity at CDMOs: ALCOA+ and 21 CFR Part 11 is the foundation of trustworthy outsourced development and manufacturing,
Data Integrity at CDMOs: ALCOA+ Principles and 21 CFR Part 11 Expectations Read More »
Introduction: ICH Q3D elemental impurities risk assessment is a critical part of pharmaceutical quality management, because metals can enter drug
ICH Q3D Elemental Impurities Risk Assessment: How a CDMO Builds the Control Strategy Read More »
Introduction: Immunogenicity Risk Assessment of Peptide Impurities is a key part of pharmaceutical development whenever an unexpected impurity appears in
Case Study: Immunogenicity Risk Assessment of a New Impurity in a Generic Peptide ANDA Read More »
