Introduction The fundamental distinction between a fit-for-purpose and a fully validated bioanalytical method is determined by the extent of experimental […]
Introduction: Choosing between analytical platforms is an important decision in biologic drug development because the assay ultimately determines what is
When Should You Use a Ligand Binding Assay Instead of LC-MS/MS for a Biologic Drug? Read More »
Introduction Quantitative NMR (qNMR) for peptide reference standard characterization is an increasingly important analytical approach for establishing the quantitative content,
Introduction: Understanding biosimilar vs biologic is important for pharmaceutical companies developing follow-on biological products, researchers evaluating biologic comparability, and healthcare
What is the Difference Between a Biosimilar and a Biologic? Read More »
Introduction: The FDA Regulatory Pathway for Peptide-Oligonucleotide Conjugates is not determined simply by identifying a product as either a peptide
What FDA Regulatory Pathway Applies to Peptide-Oligonucleotide Conjugate Therapeutics? Read More »
Introduction: For any company preparing to file an Abbreviated New Drug Application (ANDA), a Comparative Dissolution Study for ANDA is
Introduction Stabilising a Growth Hormone Protein API within poly(lactic-co-glycolic acid) (PLGA) microspheres requires the control of several degradation mechanisms, including
Introduction Developing a Nitrosamine Testing Program from scratch for a multi-product generic drug portfolio requires a well-organized, cross-functional strategy that
Introduction: USP <1663> and <1664> E&L Testing is the analytical backbone that connects a packaging or delivery-system material to a
Introduction Executing NDSRI Identification, Potency Prediction, and Confirmatory Quantification represents an important regulatory milestone for obtaining New Drug Application (NDA)
