Introduction A well-executed End-to-End Biosimilar Analytical Package establishes molecular comparability between a proposed biosimilar candidate and its reference product through […]
Introduction Chiral Purity Testing and D-Amino Acid Quantification in a synthetic octapeptide active pharmaceutical ingredient (API) requires high-resolution liquid chromatography
Introduction Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) serves as a label-free biophysical approach for investigating peptide conformational dynamics, solvent accessibility, and
Introduction Scaling Poly(lactic-co-glycolic acid) PLGA Microsphere Manufacturing from a 1g laboratory bench batch to a 500g cGMP-compliant pilot scale requires
Introduction: Peptide-Oligonucleotide Conjugates for Blood-Brain Barrier Delivery are being explored because conventional oligonucleotides generally struggle to reach therapeutic concentrations in
Introduction Poly(lactic-co-glycolic acid) PLGA Nanoparticle Development offers an advanced biomaterial platform for the encapsulation, stabilization, and delivery of fragile subunit
Introduction The Accuracy and Precision Requirements for a Validated Bioanalytical Method define the quantitative performance limits that analytical assays must
What Are the Accuracy and Precision Requirements for a Validated Bioanalytical Method? Read More »
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: 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 »
