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)
Introduction Delivering comprehensive Bioanalytical Support for an AAV Gene Therapy IND requires the validation of highly sensitive molecular and immunoassay
