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 »
Introduction: Peptide Synthesis vs Protein Manufacturing is an important distinction in pharmaceutical development, biotechnology, and analytical science, and the two
Is Peptide Synthesis the Same as Protein Manufacturing? Read More »
Introduction Selecting between an integrated contract development and manufacturing organization (CDMO) and multiple specialized vendors depends on whether a drug
Is It Better to Use One Integrated CDMO or Multiple Specialized Vendors? Read More »
Introduction Glycan profiling analysis for biosimilar characterization provides valuable insights into how critical N-glycoforms, particularly afucosylation, sialylation, and high mannose
Introduction Higher Order Structure Analysis for Biosimilar Characterization is essential because proteins with identical primary amino acid sequences can adopt
