Introduction: Forced Degradation Testing for Biosimilars is an important analytical strategy for understanding how a biosimilar drug substance changes when […]
Introduction: Dexamethasone Injection CMC requirements are a critical part of developing and submitting a generic injectable drug product through the
CMC Requirements for Dexamethasone Injection ANDA Read More »
Introduction: Silicone Lubricant Leachables are chemical substances that can migrate from silicone-lubricated components of a pharmaceutical container or drug-delivery system
Case Study: Silicone Lubricant Leachables in an Auto-Injector Primary Container Read More »
Introduction: The development of a PLGA Long-Acting Injectable Formulation for a GLP-1 receptor agonist can provide an important strategy for
Introduction: Peptide-oligonucleotide conjugate (POC) developers face a question that shapes every downstream decision — from IND strategy to exclusivity planning:
Are Peptide-Oligonucleotide Conjugates Regulated as Small Molecules or Biologics? Read More »
Introduction: CDMO support for ANDS can provide generic drug sponsors with the scientific, analytical, manufacturing, and documentation capabilities needed to
How CDMOs Support Abbreviated New Drug Submission (ANDS) for Health Canada Approval Read More »
Introduction: Generic injectable manufacturers face a unique quality challenge: unlike oral or topical products, injectables can expose patients directly to
Extractables and Leachables (E&L) Testing for Generic Injectable Drug Products at a CDMO Read More »
Introduction: Peptide-Oligonucleotide Conjugates for Blood-Brain Barrier Delivery are being explored because conventional oligonucleotides generally struggle to reach therapeutic concentrations in
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,
