Introduction: Advanced analytical techniques for injectable drugs are the methods used to confirm the identity, strength, purity, safety, and quality […]
Advanced Analytical Techniques for Injectable Drugs Read More »
Introduction: Nitrosamine formation risk in drug products is an important quality and patient safety issue because certain nitrosamines are classified
Does Drug Product Formulation and pH Affect Nitrosamine Formation Risk? Read More »
Introduction: Peptide-oligonucleotide conjugates for oncology are engineered molecules in which a peptide is chemically linked to an oligonucleotide designed to
Peptide-Oligonucleotide Conjugates for Oncology Therapeutics Read More »
Introduction: PLGA Molecular Weight and End-Group Chemistry together determine how quickly a PLGA matrix hydrolyzes and how a drug moves
Introduction Contract Development and Manufacturing Organizations (CDMOs) implement ICH Q2(R2) and ICH Q14 as an integrated, lifecycle-oriented framework that brings
ICH Q2(R2) and ICH Q14: How CDMOs Apply the Analytical Procedure Lifecycle Read More »
Introduction CDMO Quality Agreements function as legally binding quality management frameworks established under Current Good Manufacturing Practice (CGMP) regulations to
CDMO Quality Agreements: What FDA Guidance Requires and What Sponsors Should Include Read More »
Introduction Analytical Method Transfer Between CDMO Sites is a formal and documented process used to qualify a receiving Contract Development
Introduction: D-Amino Acid Impurity Analysis in Peptides is the set of analytical procedures used to detect, locate, and quantify unwanted
Introduction Phase-Appropriate CMC Development at a CDMO represents a risk-managed approach to scaling that aligns Chemistry, Manufacturing, and Controls activities
Phase-Appropriate CMC Development at a CDMO: What Changes from Preclinical to Phase III Read More »
Introduction Analytical Characterization for 505(b)(2) Peptide Products provides the comprehensive physicochemical, structural, and functional profile required to establish product safety,
