Introduction Non-enzymatic Deamidation and Aspartate Isomerization in Therapeutic Peptides are significant chemical degradation pathways that can modify peptide backbone structure, […]
Introduction Ion Mobility Mass Spectrometry enables the resolution of co-eluting isomeric peptide impurities by distinguishing gas-phase peptide ions according to
Ion Mobility Mass Spectrometry for Separating Isomeric Peptide Impurities Read More »
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
